(105 days)
The VSII system is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.
Not Found
The provided text is a 510(k) summary for the Visionsense Ltd.'s VSII System, a stereoscopic vision system for general endoscopic and laparoscopic surgical procedures. It primarily focuses on demonstrating substantial equivalence to a predicate device (ELRAN 01 Stereoscopic Laparoscope) rather than detailing performance studies and acceptance criteria for entirely new device claims.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided document. The 510(k) process for substantial equivalence often relies on demonstrating that the new device performs "as safe and effective" as the predicate, rather than establishing entirely new performance benchmarks through extensive studies typically associated with novel or high-risk devices.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred) |
|---|---|
| Same intended use as predicate device | "The VSII System has the same intended use..." |
| Similar indications to predicate device | "...and similar indications..." |
| Similar principles of operation to predicate device | "...principles of operation..." |
| Similar technological characteristics to predicate device | "...and technological characteristics as the ELRAN 01 Stereoscopic Laparoscope." |
| Minor differences in technological characteristics do not raise new safety/effectiveness questions | "The minor differences in the modified device's technological characteristics do not raise any new questions of safety or effectiveness." |
| Performance data demonstrates safety and effectiveness comparable to predicate device | "Performance data demonstrates that the VSII System is as safe and effective as the ELRAN 01 Stereoscopic Laparoscope." |
Missing: Specific quantitative acceptance criteria (e.g., minimum resolution, field of view, illumination levels, specific accuracy metrics for stereoscopy) and the quantitative results of the VSII System against these criteria. The document states "Performance data demonstrates," but does not provide the specifics of this data or the defined acceptance thresholds.
2. Sample size used for the test set and the data provenance
Missing: The document does not mention any specific "test set" in the context of device performance evaluation, nor does it provide details on sample size or data provenance (country of origin, retrospective/prospective). The assessment appears to be based on a comparison to the predicate device's established performance rather than a new standalone clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing: This information is not provided because there is no mention of a "test set" and corresponding ground truth establishment by experts for the VSII system in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing: Not applicable, as no test set or expert adjudication 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
Missing: This is not applicable to the VSII System, which is a stereoscopic vision system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a "standalone" algorithmic performance study in the context of AI. The VSII system is a viewing system, not an algorithm. The "performance data" mentioned is likely related to engineering tests and optical characteristics to ensure similar performance to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing: No "ground truth" in the clinical AI sense is mentioned, as there are no diagnostic claims or classifications being made by the device itself that would require clinical ground truth.
8. The sample size for the training set
Missing: Not applicable, as this is a hardware vision system, not an AI model that undergoes "training."
9. How the ground truth for the training set was established
Missing: Not applicable for the same reason as above.
§ 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.