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The VSn is intended to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures, 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 endoscope. An array of miniature lenses --- the Lenticular Array (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 and FDA clearance letter for the Visionsense Stereoscopic Vision System (VSn). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, detailed study designs, or performance metrics to demonstrate that the device meets specific acceptance criteria.

The document states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for nasopharyngoscopes. However, the VSn System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility." This indicates that the regulatory pathway for this device at the time did not require specific performance criteria or a study with quantified acceptance criteria in the way described in your request.

Therefore, I cannot fulfill your request for the following sections based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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 MRMC study is mentioned. The device is a direct visualization system, not an AI-assisted diagnostic tool in the sense of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a visualization system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on establishing substantial equivalence based on technological characteristics and expanding an existing indication for use, rather than presenting a performance study with specific acceptance criteria as you've requested.

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