(231 days)
The Arthrex Dual Wave Arthroscopy Fluid Management Device is intended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phases of arthroscopic surgery.
The Arthrex Dual Wave Arthroscopy Fluid Management Device is a roller, peristaltic, arthroscopic pump designed with a universal input grade switching power supply. The Arthrex Dual Wave Arthroscopy Fluid Management Device senses the connection and use of the Arthrex Shaver Adapteur System (K932699) and provides an outflow function to support the same.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The document is a 510(k) summary for the Arthrex Dual Wave Arthroscopy Fluid Management Device, which primarily focuses on demonstrating substantial equivalence to predicate devices based on device description, intended use, and conformance to voluntary standards rather than performance studies with specific statistical outcomes or acceptance criteria.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria, specific study details, sample sizes, expert ground truth, or adjudication methods. The document does not describe a clinical study or a performance study that measures specific outcomes against predefined acceptance criteria for the device itself. Instead, it refers to conformity to safety standards like EN-55011B and IEC-60601-1, which are general electrical and medical equipment safety standards, not performance-based acceptance criteria for the intended use.
§ 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.