(373 days)
A device containing X-ray film for use in diagnostic imaging procedures.
A device containing X-ray film
This document is a 510(k) clearance letter from the FDA for a Konica Mammography Cassette, Models CM and CM DS-7. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop performance. Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance, nor can I provide details on the specific study components mentioned in your request.
The 510(k) letter confirms that the device is cleared for "A device containing X-ray film for use in diagnostic imaging procedures." but it does not delve into the detailed performance metrics or study designs that led to that clearance.
§ 892.1850 Radiographic film cassette.
(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(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.