(86 days)
The Arthrex Continuous Wave III Arthroscopy Pump is intended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phases of arthroscopic surgery.
The Arthrex Continuous Wave III Arthroscopy Pump is a roller, peristaltic, arthroscopic pump designed with a universal input grade switching power supply allowing the pump to function automatically within voltages ranges found in Europe and in the Americas. The pump is designed with upgraded software, employs a combination vacuum fluorescent and dot matrix display for high visibility, uses membrane type switch overlays for user inputs, and has an added flush function.
The provided text is a 510(k) Premarket Notification Summary for the "Arthrex Continuous Wave III Arthroscopy Pump." This document primarily asserts substantial equivalence to predicate devices and describes the device's function. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment of the kind requested for AI/ML device evaluations.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details for an AI/ML device. The document is for a traditional medical device (an arthroscopy pump), not an AI/ML-driven diagnostic or therapeutic 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.