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The PVS Basic™2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic" 2 (migafocon A) and Epic 2 (migafocon A) bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted), including astigmatic corrections up to + 4.00 D requiring add power of up to + 4.00 D.

The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are available in blue. The blue tinted lenses contain D&C Green # 6. The lenses have the following dimensions and characteristics: Material: migafocon A, Indication: Daily Wear, Water Content: < 1%, Oxygen Permeability*: 74 x 10-11 Dk at 35° C., Oxygen Permeability**: 52 x 10-11 Dk at 35° C, Luminous Transmittance (blue) : 87%, Wetting Angle (receding angle): 16, Hardness (Shore D): 82.6, Refractive Index**: 1.454 (nD at 25° C), Specific Gravity: 1.10, Color: Blue. Lens Parameters: Chord Diameter: 7.0 to 10.5 mm, Center Thickness: 0.05 to 0.70 mm, Base Curve: 6.50 to 9.00 mm, Power: -20.00 to +12.00 Diopters, Bifocal Add Power: + 0.25 to +4.00 Diopters, Concentric Bifocal Add Diameter: 2.0 to 4.0 mm, Monocentric Bifocal Add Diameter: 4.0 to 9.0 mm, Monocentric Bifocal Prism: 0 to 2.5 Diopters.

This document describes the 510(k) summary for the PVS Basic™ 2 and Epic® 2 rigid gas permeable contact lenses. It focuses on demonstrating substantial equivalence to a predicate device, PVS Basics™ (paflufocon E) contact lenses, rather than a clinical study with an acceptance criteria for a new AI/medical device.

Here's the information extracted, re-framed to best fit the categories provided, acknowledging that this is a contact lens submission and not an AI or diagnostic device:

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

Since this is a submission for contact lenses demonstrating substantial equivalence, the "acceptance criteria" are the physical, optical, and chemical properties of the predicate device. The "reported device performance" are the corresponding properties of the new device being submitted. All values for the new device are presented as meeting the implied equivalence to the predicate.

Additionally, the submission includes biocompatibility testing:

• Cytotoxicity Study (ISO Agarose Overlay Method): Test article showed no evidence of causing cell lysis or toxicity. Met USP grade < 2 (mild reactivity).
• Acute Systemic Toxicity Study (ISO, mouse): No mortality or systemic toxicity from extracts. Met test requirements.
• Ocular Irritation Study (ISO, rabbit): SC and CSO test article extracts not considered irritants to ocular tissue.

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

The document does not detail specific sample sizes for each physical/chemical test. The data provenance is not explicitly stated beyond implying these are standard laboratory tests conducted by the manufacturer, Paragon Vision Sciences. It's prospective in the sense that these tests were performed on the new device for the purpose of this submission.
For the biocompatibility studies:

• Cytotoxicity: Not specified, but standard ISO agarose overlay method implies a cell culture approach.
• Acute Systemic Toxicity: "in the mouse" - specific number of mice not given.
• Ocular Irritation: "in the rabbit" - specific number of rabbits not given.

3. 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)

This is not applicable as the submission focuses on physical, optical, chemical, and biocompatibility properties of a contact lens material, not diagnostic interpretation or clinical outcomes requiring human expert "ground truth" establishment in the context of an AI device. The "ground truth" for the equivalence claim is the established properties of the predicate device as measured by standardized methods.

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

Not applicable. This is not a study requiring adjudication of human interpretations.

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 diagnostic device or an AI-assisted device.

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

Not applicable. This is not an algorithm-based device. The "standalone" performance refers to the physical, chemical, and biocompatibility characteristics of the lens itself, which are measured directly.

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

The "ground truth" in this context is the measured physical, optical, chemical, and biocompatibility properties of the contact lenses, determined using recognized ISO, ANSI, and ASTM standards/methods. The equivalence is established by direct comparison to the legally marketed predicate device's measured properties using the same or similar standard methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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