(159 days)
The VS3 is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.
The VS3 consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") system is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 system allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housinq optical relay components and light fibers. The VS3 system also includes 2D coupler capability that allows the VS3 system to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.
The provided text describes a 510(k) submission for the Visionsense VS3 Stereoscopic Vision System, a Class II medical device. However, it does not contain the detailed information required to fill out the table regarding acceptance criteria, study details, and performance metrics as it is primarily focused on establishing substantial equivalence to a predicate device.
Specifically, the document states:
- "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes."
- "However, the VS3 system and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. In addition, cleaning validation, sterilization, and software validation were performed for the subject device. The completed testing listed above demonstrates that the subject device is as safe and effective as the predicate device."
This indicates that the "study" proving the device meets acceptance criteria is primarily a series of verification and validation tests against recognized consensus standards and internal quality controls, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or other performance metrics typically associated with AI/software devices. Therefore, many of the requested fields cannot be answered from the provided text.
However, based on the information provided, here's what can be extracted and what cannot be:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety - Electrical | Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2 | Complies with recognized consensus standards. |
| Safety - Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complies with recognized consensus standards. |
| Safety - Biocompatibility | Compliance with recognized consensus standards | Complies with recognized consensus standards. |
| Safety - Sterilization | Cleaning validation, Sterilization validation | Performed; demonstrates safety and effectiveness. |
| Safety - Risk Management | Compliance with ISO 14971 | Complies with recognized consensus standards. |
| Safety - Endoscopic Equipment Specific | Compliance with IEC 60601-2-18 | Complies with recognized consensus standards. |
| Safety - Optical/Endoscopic Accessories | Compliance with ISO 8600 (Parts 1, 3, 4, 5, 6) | Complies with recognized consensus standards. |
| Software Validation | Software validation | Performed; demonstrates safety and effectiveness. |
| Functional Equivalence | Same Indications for Use, Operating Principle, Basic Design, Materials of Construction, Sterilization Method, Manufacturing Processes as predicate. | Demonstrated to be "Same" as predicate (VSi, K073279). |
| Performance - Visualization Capabilities | 3D, High Definition (HD) viewing | Provides 3D, HD viewing (an enhancement over predicate's 3D only). |
Note: The text explicitly states "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes." This implies there are no specific quantitative or clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) provided in this document as would be expected for a diagnostic AI device. The "performance" described focuses on meeting safety, electromagnetic, and material standards, and demonstrating functional equivalence to the predicate device with the added feature of HD.
Additional Information (where available or noted as unavailable):
2. Sample size used for the test set and the data provenance:
- Not provided. The document describes engineering and quality assurance validation (e.g., electrical safety, sterilization validation) against consensus standards but does not detail sample sizes or data provenance for a "test set" in the context of clinical performance data or AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This information is relevant for studies validating interpretations or diagnostic outputs, typically in AI/software clinical performance studies. The provided text does not describe such a study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As above, this pertains to expert-led ground truth establishment for performance studies.
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:
- No, an MRMC comparative effectiveness study was not done (or at least not described in this submission summary). The device is a stereoscopic vision system (hardware-based 3D visualization), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is an endoscopic system providing visualization, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The device's validation focuses on engineering and safety standards, and functional equivalence to a predicate, rather than validating against a clinical "ground truth" for diagnostic accuracy.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device in the context of this submission. "Training set" would not apply in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, this is not an AI/machine learning device.
§ 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.