(24 days)
The All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors. They develop, fix, wash and dry medical x-ray film. Properly processed x-ray films are available for reading by medical practitioners more rapidly and with more consistency than with manual processing.
automatic x-ray film processors
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details.
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the All-Pro 100 Plus and All-Pro 200 x-ray film processors. This letter indicates that the devices have been found substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not contain any technical details about performance studies or acceptance criteria.
To answer your request, I would need a different document that details the testing and validation of the device.
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). 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.