(28 days)
The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
The Arthroscopy Pump A115 is a microprocessor controlled single roller pump designed to provide fluid distention and irrigation of joint cavities during diagnostic and operative arthroscopy. The pump functions according to the peristaltic principle and consists of the following main components: a housing, a power supply, a roller wheel, a pump head, various setting keys and display elements. The pump is used with special designed irrigation tubings, a pressure remove control and a foot pedal. A constant performed redundant pressure control assures conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.
This medical device is an "Arthroscopy Pump" rather than an AI/ML device, so the requested information (acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, training set size, etc.) is not applicable in the context of the provided documentation.
The 510(k) summary for the Arthroscopy Pump A115 explicitly states:
VIII. Performance/Clinical Data:
"No performace or clinical data is provided."
Therefore, the document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed AI/ML specific questions. The submission primarily relies on substantial equivalence to predicate devices (other arthroscopy pumps) and compliance with voluntary standards for electrical safety and electromagnetic compatibility.
§ 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.