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The Valley Contax SV Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Valley Contax AFM Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Valley Contax VK Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may also be prescribed in otherwise non-diseased eyes that require a gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear are made-to-order with spherical or aspheric front surfaces, or a prism-ballasted toric front surface. The Valley Contax AFM Gas Permeable Contact Lens is made-to-order in a range of multifocal strengths and options. The Valley Contax VK Gas Permeable Contact Lens is intended for the management of irregular cornea conditions and is made-to-order in spheric, prism-ballasted toric, and multifocal front surface options. The lenses are lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A. The lenses are shipped "dry" in a polypropylene contact lens case.

The provided text describes a 510(k) premarket notification for "Valley Contax Single Vision (SV) Gas Permeable Contact Lens", "Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens", and "Valley Contax V Kone (VK) Gas Permeable Contact Lens." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel clinical study for the device's performance against specific acceptance criteria like an AI/ML product would.

As such, the information required to directly answer some of the questions (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not present in this document because it outlines a regulatory submission for contact lenses, not a study validating an AI/ML diagnostic tool.

However, based on the provided text, I can infer and state what is available regarding acceptance criteria and the "study" proving device performance in the context of a contact lens submission:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence):

For this type of device (contact lenses), acceptance criteria are not typically expressed as performance metrics like sensitivity/specificity but rather as meeting established physical properties, biocompatibility standards, and manufacturing tolerances that are considered safe and effective, similar to predicate devices. The "performance" is demonstrating these equivalencies.

Here's a table summarizing the physical properties that serve as de-facto performance metrics and acceptance criteria by demonstrating equivalence to previously cleared materials:

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

See the table above. The acceptance criteria for contact lenses in a 510(k) submission are implicitly met by demonstrating that the device's characteristics (material properties, manufacturing tolerances) are equivalent to those of legally marketed predicate devices, which are deemed safe and effective. The "performance" is establishing this equivalence through non-clinical (bench) testing and reference to previous clearances.

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

• Test set sample size: Not explicitly stated. For bench testing of manufacturing parameters and bioburden, the sample size would be determined by internal quality control protocols, but it is not detailed in this regulatory summary.
• Data provenance: For material properties, it's "reported from predicate devices," meaning the data comes from previously cleared contact lenses using the same materials. For lens design/manufacturing verification and bioburden, the data is generated from testing performed by Valley Contax, Inc. The country of origin is not specified, but the submission is to the U.S. FDA. The testing is likely prospective (i.e., designed specifically for this submission) for the manufacturing verification and bioburden.

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

• This information is not applicable and not provided. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically for diagnostic devices, especially AI/ML. For contact lenses, the "truth" is whether the physical properties meet the established specifications and manufacturing tolerances.

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

• Not applicable and not provided. Adjudication methods are relevant for subjective interpretations (e.g., reading medical images) requiring multiple reviewers. For objective measurements like contact lens parameters and bioburden, standard quality control and laboratory procedures are followed, not 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:

• No, this type of study was not done. MRMC studies are specific to evaluating the clinical performance of diagnostic medical devices, particularly those involving human interpretation of data (e.g., images) where AI tools might assist. This submission is for contact lenses, which are Class II physical devices.

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

• No, this is not applicable. This refers to the evaluation of AI/ML algorithms, which is not the device being cleared.

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

• Bench testing / Engineering specifications / Pre-established material properties from predicate devices. The "ground truth" for contact lens regulatory clearance revolves around objective measurements of physical, chemical, and biological properties, as well as adherence to manufacturing tolerances, all supported by existing standards and data from already-cleared, equivalent materials/devices. Clinical performance has been "addressed by reference to previously cleared 510(k) premarket notifications," implying that the safety and effectiveness of the materials in human eyes have already been established and accepted.

8. The sample size for the training set:

• Not applicable / Not provided. The concept of a "training set" applies to machine learning algorithms. This document describes the clearance of physical contact lenses.

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

• Not applicable. As explained above, there is no AI/ML training set for this device.

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