(28 days)
Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.
This device has no patient contacting materials and is intended to be used by trained personnel only.
The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.
Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.
The provided document is a 510(k) clearance letter from the FDA for a medical image digitizer (Film Digitizer, Model 2908). This document grants market clearance for a device based on its substantial equivalence to a predicate device. It does not contain any information regarding acceptance criteria, study details, or device performance against specific metrics.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document focuses on regulatory approval rather than technical performance validation.
§ 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.