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The Sensor Medical Family of Vitrectomy Lenses and Products allows visualization of the ocular fundus, vitreous and retinal structures during vitrectomy surgery.

The Sensor Medical Family of Vitrectomy Lenses and Products includes single-use, disposable, sterile devices for use during vitrectomy surgery. The following devices are included in the family: Plano Lens, Magnifier Lens, Bi-Concave Lens, 20 degree Prism Lens, 30 degree Prism Lens, Osher 78 D Lens, Suture Ring, Silicone Ring, and Lens Forceps.

The Sensor Medical Family of Vitrectomy Lenses and Products is designed around the classic Goldmann contact lens. Each style of lens is of similar design, with slight variations in the posterior surface shape to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with an operating microscope, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.

The lenses typically consist of a PMMA (acrylic) optical element that is applied for a short period of time directly on the globe or cornea of the eye.

Here's a breakdown of the acceptance criteria and the "study" (or lack thereof) based on the provided text, structured according to your request:

Acceptance Criteria and Device Performance

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, there are no explicit acceptance criteria for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy metrics).

The "acceptance criteria" here are implied by the demonstration of substantial equivalence to the predicate device. The performance is deemed acceptable if the new device is as safe and effective as the predicate.

Study Information (or lack thereof)

This submission relies on a demonstration of substantial equivalence to a predicate device (Ocular Instruments Disposable Vitrectomy Lens Kit, K012096), rather than a new clinical or performance study of the Sensor Medical devices themselves. The document explicitly states: "No performance data is provided since no new questions of safety and effectiveness are raised."

Given this, many of your requested points are not applicable.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set was used for a performance study. Comparison was based on design specifications and intended use against a cleared predicate device.
2. 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. No ground truth establishment for a test set was performed.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used.
4. 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. This device is an optical lens for direct visualization during surgery, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device, to which the new device is being compared.
7. The sample size for the training set: Not applicable. No training set was used.
8. How the ground truth for the training set was established: Not applicable. No training set was used.

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