(57 days)
The Pensil Trauma is a wall-mounted radiographic cassette holder device that is a 1110 Total Tradition 10 and position radiographic cassettes for a radiographic exposure for medical use.
The Pensil Trauma is a wall-mounted radiographic cassette holder device.
I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for the "Pensil Trauma, Model WW56100" device, identifying it as a wall-mounted radiographic cassette holder.
While it mentions the device is "substantially equivalent" to legally marketed predicate devices, it does not include any specific performance metrics, acceptance criteria, or details regarding studies (sample sizes, ground truth, expert qualifications, etc.) that would prove the device meets such criteria.
The letter focuses on regulatory approval based on substantial equivalence, general controls, and compliance with manufacturing practices, rather than providing a technical performance evaluation.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.