(38 days)
Model 2908 Mammo pro is intended for covering analog Medical x-ray films to digital images.
The device is indicated for the digitization of mammography Imaged for review and analysis, but not as the sole basis for screening or diagnosis.
The device is indicated for the digitization of mammography images for storage and display not for primary image diagnosis.
Film Digitizer, Model 2908 Mammo Pro
The provided document is a 510(k) clearance letter from the FDA for a medical image digitizer (Film Digitizer, Model 2908 Mammo Pro). It does not contain details about specific acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
Therefore, I cannot provide the requested information as the source document does not contain it. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) are typically found in the 510(k) submission document itself, or in associated test reports, which are not part of this clearance letter.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.