(96 days)
The OPserver LAP is an integral combination unit comprised of the following legally marketed Karl Storz equipment intended for use in laparoscopic surgeries: XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH.
The XENON 300 is a 300 watt short arc Xenon lamp light source designed to supply light for endoscopic diagnostic and surgical procedures.
The Video Camera is a camera system designed for use in laparoscopic surgeries. The TRICAM®/TELECAM® camera head is suitable for attachment to any rigid or flexible endoscope.
The THERMOFLATOR® is a gas insufflator designed for laparoscopic surgical and diagnostic procedures. The device is designed to carefully deliver large flow rates for rapid insufflation, and to monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity.
The UNIDRIVE® II is the control unit that operates the motorized handles during endoscopic surgical procedures.
The AUTOCON® II 400 is an electrosurgical generator that is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during endoscopic surgeries.
The LAPAROMAT® is a high-capacity suction/irrigation device for use by qualified surgeons to infuse and aspirate sterile irrigation solutions into the peritoneal cavity to rinse or remove carbon deposits, blood clots, or excised tissue during laparoscopic and pelviscopic surgical procedures.
The QUADRO SWITCH, in conjunction with its associated handpiece or footswitch, functions as a suction/irrigation control switch device that controls the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.
The OPserver LAP is comprised of XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH. It is controlled via the Karl Storz SCB either by touch screen or by voice activation.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device conformance. The document is a 510(k) premarket notification summary for the Karl Storz Endoscopy OPserver LAP, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed study results or acceptance criteria.
Specifically, the document states: "The KSEA OPserver LAP is substantially equivalent to the predicate devices since the performance specifications, safety features, and intended uses are identical. The minor differences between the KSEA OPserver LAP 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."
This means the submission relies on the established safety and effectiveness of its component parts, which are already legally marketed, rather than presenting a new study with specific acceptance criteria and performance data for the combined unit.
Therefore, I cannot provide the following information from the given text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: No specific test set or data provenance for a study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a study is not mentioned.
- Adjudication method for the test set: No adjudication method is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study is mentioned.
- If a standalone performance study was done: No standalone performance study specific to the OPserver LAP as a combined unit is described beyond the components.
- The type of ground truth used: No ground truth for a study is mentioned.
- The sample size for the training set: No training set or details about it are provided.
- How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.