(127 days)
The Vertos Medical mild® Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
The Vertos Medical mild® Device Kit is a set of specialized arthroscopic surgical instruments. They are supplied sterile, for single use only.
The provided text does not describe an AI medical device or a study proving that it meets acceptance criteria. The document is a 510(k) premarket notification for a traditional medical device, the "Vertos Medical mild® Device Kit," which is a set of specialized arthroscopic surgical instruments.
Therefore, I cannot extract the information required in the requested format as it pertains to AI medical devices and their performance studies. The document only mentions "Biocompatibility evaluation," "Bench testing," and "Cadaveric testing" to demonstrate compliance and substantial equivalence to predicate devices, not AI performance criteria or studies.
§ 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.