S-52 ELECTRONIC VIDEO LAPAROSCOPE by SOPRO

Based on the provided text, the submission is a 510(k) premarket notification for the SOPRO S-52 Video Laparoscope. This type of submission asserts substantial equivalence to legally marketed predicate devices, rather than presenting a study demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the provided document.

Here's an analysis of the information that can be extracted and a clear indication of what is not available:

1. A table of acceptance criteria and the reported device performance

Not provided. The document indicates the S-52 Video Laparoscope is considered substantially equivalent to existing devices (Circon/ACMI, Storz, Stryker, Smith & Nephew, and Olympus) because its "design is virtually identical," "technology virtually identical," "specifications very similar," and "intended use the same." This implies that the device is expected to perform comparably to these predicate devices, but no specific performance metrics or acceptance criteria are stated, nor are any direct performance results reported for the S-52.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. No test set or associated data is mentioned, as this is a substantial equivalence submission based on design and technological similarity, not a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not provided. This device is a video laparoscope, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not provided. This is a hardware device (video laparoscope), not an algorithm or AI system. Standalone algorithm performance is not relevant or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not provided. No ground truth is mentioned, as no performance study was conducted or reported.

8. The sample size for the training set

Not provided. No training set is applicable or mentioned for this type of device and submission.

9. How the ground truth for the training set was established

Not provided. No training set or ground truth establishment process is applicable or described.

Summary of what is known:

Device Name: SOPRO S-52 Video Laparoscope
Regulatory Status: Substantially Equivalent (K973795) to existing devices.
Predicate Devices: Circon/ACMI, Storz, Stryker, Smith & Nephew, Olympus.
Basis for Equivalence: Virtually identical design, technology, very similar specifications, and same intended use as predicate devices.
Intended Use: "Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals."

Summary

Regulation Number and Section

§ 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.