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The hand-held device is intended to provide better visualization of mammographic films for review by radiologists. A portion of the film image is digitized, processed, and displayed in real-time as a magnified view on an adjacent monitor.

The hand-held device is intended to provide better visualization of mammographic films for review by radiologists. A portion of the film image is digitized, processed, and displayed in real-time as a magnified view on an adjacent monitor.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Personal Digital Workstation® (PDW) Film Digitizing Camera and Digital Workstation."

While it mentions the device name, regulation number, regulatory class, and product code, as well as its intended use, it does not provide:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. Clinical study details, if they were part of the submission, are not included in this FDA clearance letter.

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