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The Diagnostic Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Diagnostic lenses are indicated for use during vitreoretinal surgical procedures.
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.

The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.

This 510(k) premarket notification for the "Super View Disposable BIOM Lens Set" from Insight Instruments, Inc. does not contain a study to prove acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device. This is a common pathway for Class II medical devices, where the focus is on showing that the new device is as safe and effective as a legally marketed device, rather than proving novel efficacy.

Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present in this document. I will fill in the table and address the other points based on the information provided, highlighting where data is absent due to the nature of the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The concept of "acceptance criteria" in this context is implicitly about demonstrating substantial equivalence across these characteristics. There are no quantitative performance metrics (e.g., optical resolution, magnification, field of view metrics) or statistical thresholds explicitly stated as acceptance criteria for the performance of the device itself. The "performance" being reported is the similarity to the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not applicable. This document does not describe a performance study with a test set of data. The "test" is the comparison of characteristics against the predicate device.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set was analyzed by multiple reviewers requiring adjudication.

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

• MRMC Study: No. This device is a diagnostic lens, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Standalone Performance: No. This device is a physical diagnostic lens. It does not involve an algorithm or AI component to have a "standalone" performance in that sense.

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

• Type of Ground Truth: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the characteristics and established safety/effectiveness of the predicate device. The new device's characteristics are compared against the predicate as the benchmark.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development or training of an algorithm or AI model.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable.

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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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