(69 days)
The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.
The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components:
- Endoscope
- Light source
- Camera Control Unit (CCU)
- Camera
- Display monitors
- 2D Endoscope coupler
The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-0T 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 Stereoscopic High Definition Vision System. Model VS3-OT allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-OT also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-OT to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way a typical performance study for AI/ML devices might. Instead, it focuses on general performance standards, substantial equivalence to predicate devices, and regulatory compliance.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of comparison to predicate devices, particularly regarding technical specifications. The study described is a comparison of the subject device (VS3-OT) with legally marketed predicate devices, focusing on demonstrating substantial equivalence rather than a standalone performance study with a test set, ground truth, and human readers in the traditional sense.
Here's an attempt to structure the information according to your request, highlighting what is present and what is absent:
Acceptance Criteria and Study for Visionsense Ltd VS3 Stereoscopic High Definition Vision System, Model VS3-OT
The provided document describes the regulatory submission for the VS3 Stereoscopic High Definition Vision System, Model VS3-OT, focusing on demonstrating substantial equivalence to predicate devices rather than a standalone performance study with explicit acceptance criteria and corresponding performance metrics for a novel AI/ML algorithm.
The "acceptance criteria" can be inferred from the technical specifications of the predicate devices which the subject device aims to match or exceed to demonstrate substantial equivalence. The "study" refers to the comparison table provided in the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like the VS3-OT (an endoscope), performance standards often relate to optical and physical characteristics. Since this is a substantial equivalence submission, the "acceptance criteria" are the performance characteristics of the predicate devices. The "reported device performance" is the VS3-OT's specifications.
| Acceptance Criteria (from Predicate Devices) | Reported Device Performance (VS3-OT Subject Device) | Notes |
|---|---|---|
| Endoscope diameter: | ||
| - VS3 Neurosurgery: 4 - 5.5 mm | 4 – 5.5 mm | Meets |
| - VSii Arthroscope: 4 - 5 mm | ||
| - Karl Storz C-Mount Arthroscope: 4mm | ||
| Endoscope length: | ||
| - VS3 Neurosurgery: 175 - 300 mm (±5 mm) | 175 - 300 mm (±5 mm) | Meets |
| - VSii Arthroscope: 175 - 300 mm (±5 mm) | ||
| - Karl Storz C-Mount Arthroscope: 175 mm | ||
| Working distance range: | ||
| - VS3 Neurosurgery: 7 - 70mm | 7 - 70mm | Meets |
| - VSii Arthroscope: 7 - 60mm | ||
| - Karl Storz C-Mount Arthroscope: 7 - 70mm | ||
| Field of view: | ||
| - VS3 Neurosurgery: 70°-95° | 70°-95° | Meets |
| - VSii Arthroscope: 70° | ||
| - Karl Storz C-Mount Arthroscope: 95° | ||
| Direction of View: | ||
| - VS3 Neurosurgery: 0° - 70° | 0° - 70° | Meets |
| - VSii Arthroscope: 0° - 70° | ||
| - Karl Storz C-Mount Arthroscope: 0° - 70° | ||
| Horizontal Resolution: | ||
| - VS3 Neurosurgery: >199 lpf | >199 lpf | Meets (also > VSii) |
| - VSii Arthroscope: >150 lpf | ||
| - Karl Storz C-Mount Arthroscope: >199 lpf | ||
| Vertical Resolution: | ||
| - VS3 Neurosurgery: >199 lpf | >199 lpf | Meets (also > VSii) |
| - VSii Arthroscope: >140 lpf | ||
| - Karl Storz C-Mount Arthroscope: >199 lpf | ||
| Depth of Field: | ||
| - All Predicates: 7 - 30mm and 15 - 60mm | 7 - 30mm and 15 - 60mm | Meets |
Note: "Meets" indicates that the subject device's reported performance is comparable to or better than the predicate devices' specifications, supporting the claim of substantial equivalence for these technical characteristics.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML algorithm evaluation with a specific sample size of cases or images. The "study" relies on a direct technical comparison against the published specifications of predicate devices. There is no information about data provenance (e.g., country of origin, retrospective/prospective) for a test set, as such a test set is not explicitly detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a test set that requires expert-established ground truth for an AI/ML algorithm. The comparison is based on objective technical specifications.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or expert review process described in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not performed or described in this submission. The device is an imaging system (endoscope), not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a surgical vision system; it is not an AI algorithm performing standalone analysis.
7. The Type of Ground Truth Used
The "ground truth" implicitly used is the published technical specifications and performance characteristics of the legally marketed predicate devices, which serve as the benchmark for demonstrating substantial equivalence. There is no explicit mention of pathology, outcomes data, or expert consensus being used as ground truth for a novel AI algorithm's performance.
8. The Sample Size for the Training Set
Not applicable. This submission is for a conventional medical device (endoscope), not an AI/ML system developed with a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set for an AI/ML algorithm, the method of establishing its ground truth is not relevant here.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.