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The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.

The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.

The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.

The lenses are provided sterile for single use.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is for the Volk Disposable Contact Laser and Diagnostic Lens, a Class II medical device. It's a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to legally marketed predicate devices, rather than submitting a full-blown PMA (Premarket Approval) which would typically require extensive clinical trials.

The provided text focuses on demonstrating substantial equivalence, not on establishing specific performance criteria against a predefined standard for a novel device. As such, there is no detailed "acceptance criteria" table in the traditional sense of performance metrics because the device is a contact lens and its primary function is direct visualization, similar to existing devices.

However, based on the "Performance Data" section, we can infer the critical acceptance criteria and studies that were performed to support the device's safety and effectiveness for its intended use, leveraging its similarity to predicates.

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

Regarding the study that proves the device meets the acceptance criteria, and further details as requested:

This submission is a 510(k) for a device claiming substantial equivalence, not a de novo or PMA where extensive clinical studies proving novel performance are typically required. Therefore, the "studies" mentioned are primarily validation testing to confirm specific aspects of the device's manufacturing and stability, rather than clinical trials assessing diagnostic accuracy or treatment efficacy compared to a gold standard.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• The document does not specify the sample sizes for the sterilization validation testing or the shelf-life testing. These would typically be determined by established standards for such validation (e.g., ISO standards for sterilization, statistical sampling for shelf-life).
• The data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing (Volk Optical Inc. in Mentor, Ohio, USA). These would be prospective validation studies designed to test the sterility and shelf life of the newly manufactured disposable lenses.

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

• Not applicable / Not mentioned. For sterilization and shelf-life testing, "ground truth" is established by laboratory measurements against defined specifications (e.g., microbial load reduction, chemical stability) rather than expert consensus on a diagnostic outcome.
• For the optical performance, the "ground truth" and expertise would logically stem from the design and manufacturing capabilities of Volk, which has a long history in ophthalmic optics, and the clinical experience with their predicate devices. The statement "Each model lens is similar in design, but provide different optical elements to provide excellent visualization" suggests reliance on established optical design principles and potentially in-house optical testing.

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

• Not applicable / Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient outcomes requires reconciliation among multiple experts. The studies cited are laboratory-based validation tests (sterilization, shelf life) which rely on analytical measurements and adherence to protocols, not human 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

• Not applicable. This device is a passive optical lens, not an AI-powered diagnostic system. No MRMC study was performed or is relevant for this type of device.

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

• Not applicable. This device is a physical optical lens, not an algorithm or AI system. Its function inherently requires a human operator (the clinician) to use it for diagnosis or therapy.

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

• For sterilization validation: The ground truth is the absence of viable microorganisms to a specified sterility assurance level (SAL), measured by biological indicators and microbiological testing methods.
• For shelf-life testing: The ground truth is the stability of the device's material properties, packaging integrity, and sterility over time, measured by physical, chemical, and microbiological tests at various time points.
• For optical performance: The ground truth is (implicitly) the ability to provide "excellent visualization," which is assessed by design specifications and comparison to the known performance of predicate lenses.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Not applicable. As above, no training set for an AI model.

Summary of the 510(k) Approach:

The core of this 510(k) submission relies on substantial equivalence to predicate devices that have been legally marketed. The performance data provided mainly addresses the differences between the proposed device and its predicates – specifically, the fact that the new lenses are disposable and sterile. Therefore, the critical acceptance criteria and studies focus on proving the safety and efficacy of these new features (sterility and stability over a shelf life) for a device that otherwise shares fundamental design and intended use with its predicates. No complex clinical trials or AI performance evaluations are presented because they are not required for this type of device and submission pathway.

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