(78 days)
The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during gynecologic laparoscopic surgical procedures.
The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.
The provided text describes a 510(k) summary for the Karl Storz Unimat Plus, a suction/irrigation pump. This document is a regulatory submission for a medical device that performs a physical function (suction/irrigation) and does not involve AI, image analysis, or diagnostic capabilities.
Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, or reader studies for AI-powered devices are not applicable here.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices by ensuring that the basic features, intended uses, and safety/effectiveness are similar. It explicitly states: "The minor differences between the Karl Storz Unimat Plus and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."
To address your request directly, but acknowledging the mismatch with the provided input:
Given that this is a mechanical device, performance acceptance criteria would typically revolve around:
- Flow Rate: Achieving and maintaining the specified irrigation/aspiration flow rate.
- Pressure: Maintaining the specified maximum irrigation pressure.
- Safety: Ensuring there are no electrical hazards, leakage, or mechanical failures during operation.
- Biocompatibility: If applicable, materials in contact with body fluids must be biocompatible.
- Sterility: If applicable, sterile components meet sterility assurance levels.
A "study" to prove these would involve engineering tests, bench testing, and potentially animal or simulated use testing to confirm the device meets its design specifications and operates safely. It would not involve human experts establishing ground truth, MRMC studies, or training/test sets as would be the case for AI/diagnostic devices.
Since the provided document is a summary and not the full submission detailing the specific tests performed to demonstrate substantial equivalence for the Unimat Plus, I cannot fill out the requested table or answer the numbered questions in the context of an AI/diagnostic device. The information simply isn't present for this type of device.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.