{"id":12333,"date":"2022-07-25T16:47:11","date_gmt":"2022-07-25T07:47:11","guid":{"rendered":"https:\/\/microncro.com\/?post_type=resources&p=12333"},"modified":"2026-06-11T18:46:06","modified_gmt":"2026-06-11T09:46:06","slug":"ai_cad","status":"publish","type":"resources","link":"https:\/\/microncro.com\/en\/resources\/ai_cad\/","title":{"rendered":"Computer-Aided Detection\/Diagnosis (CAD) Using AI"},"content":{"rendered":"
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Computer-aided detection\/diagnosis (CAD) is generally defined as systems that assist doctors to interpret medical images and make diagnostic decisions. Advancing along with generation by generation, CAD products have been improving their performance to meet the clinical needs. Notably, the accomplishments of CAD are highly expected since artificial intelligence (AI) technology with high image processing ability has been used in system development.<\/p>\n\n\n\n

It is necessary to prove efficacy before a new CAD product can be applied to clinical sites. A good result of the CAD product only by itself may not be enough. (For example, good accuracy in detecting lesions by using the image data is also used in the development.) It may be necessary to demonstrate specifically to acquire the authorities\u2019 approval. The essential question in approval qualifications is:<\/p>\n\n\n\n

What kind of benefit can the new CAD system bring to the real clinical world?<\/strong><\/p>\n\n\n\n

If you are considering entering the Japanese market, Micron may be your best choice for a partner to acquire approval. We provide extensive services from the beginning of market positioning and clinical trial design based on the consultation with PMDA, the conduction of clinical performance study (reader study), and to the submission of the final documents for approval.<\/p>\n\n\n\n

An Example of Micron\u2019s Workflow: Assisting CAD Approval<\/strong><\/h2>\n\n\n\n
Consultation with PMDA<\/strong><\/td>About market positioning: classification of medical devices (Class I to IV), comparison with the predicate devices, Notification or Approval.

About the performance test and clinical trial design, e.g. diseases\/conditions of interest, endpoints, sample size, statistical analysis, reference standard, etc.<\/td><\/tr>
Development of the Study Protocol<\/strong><\/td>To develop documents including study protocol for the standalone performance assessment, clinical performance assessment and other manuals.<\/td><\/tr>
Development of the Reference Standard*<\/strong><\/td>To define the reference standard, e.g. assessment result of radiological images by the clinical truthers, pathological test result.

To create the reference standard data \/ label.
*Reference Standard: Also known as \u201cgold standard\u201d or \u201cground truth\u201d.<\/td><\/tr>
Standalone Performance Study<\/strong><\/td>To test the detection accuracy by CAD alone by comparing CAD\u2019s output and the reference data.

To specify characteristics of CAD output, e.g.  imaging findings related to false positive or false negative.

To conduct subgroup analysis based on important covariates, e.g. lesion size.<\/td><\/tr>
Pilot Study (Optional)<\/strong><\/td>To test the clinical performance study procedures, especially in the case of lacking previous supporting evidence.

The pilot study result helps to estimate the sample size of study population and necessary reader numbers.<\/td><\/tr>
Clinical Performance Study \/ Reader Study<\/strong><\/td>To use the design of multiple reader multiple case (MRMC) study, comparing the performance results of readers\u2019 interpretation by using CAD (with CAD) and not using CAD (without CAD).

To arrange the reading sequences, e.g. sequential design, cross-over design.

To conduct the readers\u2019 training on how to use the CAD while reading and how to understand CAD\u2019s output.<\/td><\/tr>
Statistical analysis of the Study Result<\/strong><\/td>To conduct the receiver operating characteristic (ROC) curve analysis, e.g. ROC, LROC, FROC, AFROC, etc.

To demonstrate by providing the statistical analysis result of \u201cwith CAD\u201d superior to \u201cwithout CAD\u201d.<\/td><\/tr>
Approval Document Submission<\/strong><\/td>To develop the clinical study report.

To prepare other necessary documents and data for approval.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n\n\n

Micron\u2019s Work Experience of Assisting CAD Approval<\/strong><\/h2>\n\n\n\n
Disease Area<\/th>Work Description<\/td><\/tr>
Oncology<\/td>\u2713\u3000Survey of the substantial equivalence with the predicate devices<\/td><\/tr>
Orthopedics<\/td>\u2713\u3000Assisting in development of the protocol and other documents<\/td><\/tr>
Oncology<\/td>\u2713\u3000Consultation with PMDA
\u2713\u3000Assisting in development of the protocol and other documents
\u2713\u3000Development of the Reference Standard<\/td><\/tr>
Oncology<\/td>\u2713\u3000Development of the Reference Standard<\/td><\/tr>
Oncology<\/td>\u2713\u3000Consultation with PMDA
\u2713\u3000Assisting in development of the protocol and other documents
\u2713\u3000Development of the Reference Standard
\u2713\u3000Standalone Performance Study
\u2713\u3000Preliminary Study and Clinical Performance Study
\u2713\u3000Statistical analysis
\u2713\u3000Development of the clinical study report<\/td><\/tr>
Oncology<\/td>\u2713\u3000Consultation with PMDA
\u2713\u3000Development of the Reference Standard
\u2713\u3000Standalone Performance Study
\u2713\u3000Preliminary Study and Clinical Performance Study
\u2713\u3000Statistical analysis
\u2713\u3000Development of the clinical study report<\/td><\/tr>
Oncology<\/td>\u2713\u3000Survey of the substantial equivalence with the predicate devices<\/td><\/tr>
Oncology<\/td>\u2713\u3000Survey of the substantial equivalence with the predicate devices<\/td><\/tr>
Dementia<\/td>\u2713\u3000ICCC (In Country Clinical Care-taker)<\/td><\/tr>
Dementia<\/td>\u2713\u3000Consultation with PMDA
\u2713\u3000Assisting in development of the protocol and other documents\u200b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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