(122 days)
The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal arthroscope. An array of miniature lenses - the Lenticular Arrav (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human "stereo vision" obtained when the eyes simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.
The provided text is a 510(k) summary for the Visionsense Stereoscopic Vision System (VSn). It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or detailed study results demonstrating performance against such criteria.
The section titled "Performance" states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for arthroscopes. However, the VSn System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility."
This indicates that the submission primarily relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with defined acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document for product performance. The document mentions compliance with "international standards for electrical safety, electromagnetic compatibility, and biocompatibility," which serve as regulatory acceptance criteria for device components, but not performance criteria related to its imaging capabilities or clinical effectiveness.
- Reported Device Performance: Not detailed in terms of a clinical or technical performance study with specific metrics. The document focuses on the system's ability to provide "stereo vision" by capturing images from slightly different angles and processing them for display.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. The document does not describe a clinical or technical performance study with a test set.
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 applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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 applicable/Not provided. This device is a vision system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a vision system for human use, not an automated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided.
8. The sample size for the training set:
- Not applicable/Not provided. The document does not describe a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of available information related to performance/equivalence:
- Device: Visionsense Stereoscopic Vision System (VSn)
- Intended Use: Viewing internal surgical sites during anterior and posterior spinal procedures (nucleotomy, discectomy, foraminotomy), general surgical procedures, and visualization of ventricles and structures within the brain during neurological surgical procedures.
- Technological Characteristics: Proprietary CCD camera with a Lenticular Array to capture images from slightly different angles, mimicking natural human stereo vision. Images are processed and presented on a stereoscopic display panel.
- Basis for Clearance: Substantial Equivalence to predicate devices (K081102, K073279, K990635, K051827) and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility. The current submission expands the indications for use based on similarity to previously cleared versions and other endoscopes.
- Performance Standards: No specific performance standards or special controls under Section 514 for arthroscopes.
§ 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.