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The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.

The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.

This document is a 510(k) summary for a medical device called "Volk Disposable Vitrectomy Lenses." A 510(k) submission is typically for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way AI/ML devices often require.

Therefore, many of the requested elements for an AI/ML device study – like acceptance criteria in terms of performance metrics (sensitivity, specificity), expert involvement for ground truth, sample sizes for test/training sets, or MRMC studies – are not applicable to this type of traditional medical device submission.

The "study" here is a comparison with predicate devices to demonstrate substantial equivalence, not a clinical performance study as one would expect for AI/ML.

Here's a breakdown of what can be extracted based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" in design, intended use, materials, and sterile presentation (if applicable) to one or more legally marketed predicate devices. There are no explicit performance metrics (e.g., accuracy, sensitivity, specificity) stated as acceptance criteria in this document because it's a contact lens, not a diagnostic algorithm.
• Reported Device Performance: The document asserts that the Volk Disposable Vitrectomy Lenses are "substantially equivalent in design, material, classification, and intended use" to the predicate devices. The "performance" being demonstrated is the functional equivalence of the lens for its intended diagnostic and therapeutic use.

2. Sample size used for the test set and the data provenance

• Not Applicable. This is not an AI/ML device or a clinical performance study involving a "test set" in the context of data. The "test" here is a comparison of device specifications to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See point 2. Ground truth establishment for a diagnostic algorithm is not relevant for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 2.

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. This is not a software device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. There is no "ground truth" in the AI/ML sense. The "ground" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. See point 2.

9. How the ground truth for the training set was established

• Not Applicable. See point 2.

In summary: The provided document describes a 510(k) submission for a traditional medical device (a contact lens). The "study" referenced is a comparison to predicate devices for substantial equivalence, not a performance study of an AI/ML diagnostic or therapeutic algorithm. Therefore, the questions designed for AI/ML device evaluation are largely not applicable.

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Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

Disposable Vitrectomy Lens

This document is a 510(k) clearance letter from the FDA for a Disposable Vitrectomy Lens. It does not contain information about acceptance criteria or a study proving the device meets them. The letter simply states that the FDA has reviewed the 510(k) notification and found the device to be substantially equivalent to devices marketed prior to May 28, 1976.

Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report.

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