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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Precision Ideal Eyes Arthroscopes". This letter primarily deals with the administrative aspects of the FDA's substantial equivalence determination and regulatory compliance requirements.
It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.
Therefore, I cannot fulfill your request for this specific information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a 510(k) submission summary, or a clinical study report for the device.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.