(202 days)
The ImagClear® System is intended to digitize analog medical images, which will be viewed, archived, or electronically shared with other health care professionals. The ImagClear® System is specifically indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.
Essentially, the ImagClear® System is composed of two previously cleared devices: (1) the ImagClear® Film Digitizer, which DBA obtained FDA 510(k) clearance for use as a medical film digitizer with a mammography indication; and (2) a modified version of the previously Galen™ Software. The interfacing of these two previously cleared devices raise no new questions of safety or effectiveness because it does not alter the intended use of either device.
The first component of the ImagClear® System, the ImagClear® Film Digitizer, is a CCD-based digitizer which provides 16 bits of grayscale resolution. It produces at minimum a 4K x 5K image matrix, which is adequate for high quality mammography films. The second component of the ImagClear® System, the modified Galen™ Software, organizes the digitized mammography images into studies and sessions. The digitized mammogram studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between left and right breasts or old and new images). The software also allows physicians or technicians to create online mammography reports. In addition, the digitized mammogram studies and sessions and on-line reports may be viewed, archived on a central file server, or electronically shared with other health care professionals.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, the submission states:
"Performance Data: None required"
This indicates that, for this 510(k) submission, the FDA did not require specific performance data to demonstrate substantial equivalence to predicate devices. The basis for clearance was the argument that the ImagClear® System is essentially a combination of two previously cleared devices (ImagClear® Film Digitizer and modified Galen™ Software) and that the modifications made to integrate them did not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this type of performance data was explicitly stated as "None required" in this 510(k) summary.
§ 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.