(475 days)
The Karl Storz Rigid Telescopes for Obstetrics and Gynecology and their predicate devices are designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures.
The Karl Storz devices are straight-shafted, rod lens-type rigid telescopes. All body contact materials are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use.
The provided text is a summary of safety and effectiveness for Karl Storz Rigid Telescopes for Obstetrics and Gynecology, a medical device. This document is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device.
The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically found in detailed clinical trial reports or validation studies for AI/machine learning medical devices. The provided text does not contain any of these details.
The document states: "The Karl Storz Rigid Telescopes for Ob/Gyn are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the Karl Storz Rigid Telescopes for Ob/Gyn and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices."
This indicates that the device's acceptance was based on showing equivalence to existing, approved devices, not necessarily on meeting new, specific quantitative performance criteria through a standalone study as would be described for an AI/ML device.
Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, ground truth definitions, or information about AI performance, as this information is not present in the provided text. The document is from 1996 and describes an optical instrument, not an AI-powered diagnostic or therapeutic device.
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600 Corp
Karl Storz Endoscopy America, Inc.
600 Corporate Culver City, California 90230-760() Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
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MAY 1 6 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
The Karl Storz Rigid Telescopes for Obstetrics and Gynecology and their predicate devices are designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures. The Karl Storz devices are straight-shafted, rod lens-type rigid telescopes. All body contact materials are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use.
The Karl Storz Rigid Telescopes for Ob/Gyn are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the Karl Storz Rigid Telescopes for Ob/Gyn and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.
§ 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.