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The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.

The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.

This document describes a 510(k) premarket notification for a new rigid gas permeable (RGP) contact lens, Oxfore®100 (hexafocon A), seeking to establish substantial equivalence to a predicate device, the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404).

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it compares the characteristics of the new device (Oxfore®100) directly against its predicate device (Boston XO™), concluding they are "substantially equivalent." The implicit acceptance criterion is that the new device's material and physical properties should be comparable to or meet the established standards of the predicate device and relevant guidance documents.

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FluoroPerm® 92 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 92 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 60 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 60 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS® rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® toric contact lenses with Tangible Hvdra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 30 rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses with Tanzible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 30 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon Thin rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin'm toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon Thin™ contact lenses with Tangible Hydra-PEG are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eves.

FluoroPerm® 151 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 151 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 151 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® 100 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 lenses with Tangible™ Hydra-PEG are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the following currently marketed contact lens materials: paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30. Paragon Thin™), paflufocon D (FluoroPerm® 151, Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber (not in all colors and materials). The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve. The FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin™ FluoroPerm®151, and Paragon HDS® 100 lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The provided text describes a 510(k) premarket notification for various rigid gas permeable (RGP) contact lenses treated with Tangible™ Hydra-PEG. It details the device, its intended use, and a comparison to predicate devices, but it does not include a detailed study with specific acceptance criteria and performance metrics (like sensitivity, specificity, AUC) typically found in AI/ML device studies.

The "Acceptance Criteria" provided in the document refers to the general safety and effectiveness of the contact lenses, focusing on material properties, biocompatibility, and stability, rather than diagnostic performance metrics. The "study" mentioned is primarily non-clinical and previous clinical data from predicate devices.

Therefore, I cannot populate the table and answer the study-specific questions as they would apply to an AI/ML diagnostic or prognostic device study. Instead, I will extract the information that is present regarding the device's characteristics and the evaluations conducted.

Here’s a summary based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for contact lenses with a surface coating, the "acceptance criteria" are related to biocompatibility, material properties, and stability, rather than typical diagnostic performance metrics (e.g., sensitivity, specificity) for AI/ML devices. The key performance metric explicitly reported is wettability.

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FluoroPerm® 92 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only.

FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only. FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 60 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 60 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 dionters that does not interfere with visual acuity. FluoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only. FluoroPerm® 60 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 30 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Paragon Thin™ rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin" rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon Thin" contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 151 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 151 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 151 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Paragon HDS® 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only. Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® 100 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 30, Paragon Thin™, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; patlufocon A (FluoroPerm®92), patlufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30, Paragon Thin"), and paflufocon D (FluoroPerm® 151, Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers.

The lenses may be tinted to offer a handling aid for locating the lens. The lenses may be available with an ultraviolet absorber (not in all colors and materials).

The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve.

FluoroPerm® 92, FluoroPerm® 60, FluoroPerm® 151, Paragon HDS®, and Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92. FluoroPerm® 60, FluoroPerm® 151, Paragon HDS® 100 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only.

FluoroPerm® 30 and Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

The contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. .

The safety and effectiveness of paflufocon A (FluoroPerm® 92), patlufocon B (FluoroPerm® 60 and Paragon HDS®), paflufocon C (FluoroPerm® 30 and Paragon Thin") and paflufocon D (FluoroPerm® 151 and Paragon HDS® 100) materials as rigid gas permeable contact lenses have been demonstrated in PMA P870024 and several of its supplements.

I am sorry, but the provided text is a 510(k) summary for contact lenses and does not contain information about the acceptance criteria and study details for a device whose performance is being evaluated. The document focuses on the indications for use and substantial equivalence of various rigid gas permeable contact lenses to previously approved predicate devices. It does not include data on the performance of a device against specific acceptance criteria, nor does it describe studies with test sets, ground truth methodology, expert involvement, or AI components.

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HDS HI 1.54™ rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

HDS HI 1.54™ rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of refractive ametropia in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. HDS HI 1.54™ toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters.

HDS HI 1.54™ bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

HDS HI 1.54™ contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery, in otherwise non-diseased eyes.

HDS HI 1.54 (pahrifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior, or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.

The HDS HI 1.54 rigid gas permeable contact lens material is a thermoset copolymer derived from acrylate, silicone acrylate, and fluorosilicone acrylate monomers, dimers and oligomers.

The HDS HI 1.54 rigid gas permeable tinted lenses offer a handling aid for locating the lens and may be plasma treated.

Here's a breakdown of the acceptance criteria and the study details for the Paragon HDS HI 1.54 rigid gas permeable contact lens, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a formal table; instead, the submission focuses on demonstrating "substantial equivalence" to the predicate device (FluoroPerm 30) through comparative performance data and clinical outcomes. The device performance is generally presented by comparing the HDS HI 1.54 to the predicate or demonstrating acceptable clinical observations.

Given the information, I've constructed a table highlighting key properties and clinical outcomes where performance comparison implicitly serves as the acceptance criterion (i.e., being comparable to or better than the predicate, or within expected clinical ranges).

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 76 subjects (152 eyes) were enrolled. 64 subjects (84.2%) completed the study.
   • Data Provenance: The study was a multi-site, randomized, double-masked clinical study. The country of origin is not explicitly stated, but the submission is to the US FDA, implying that the study was likely conducted in the US or under ICH GCP guidelines applicable to US submissions. The study was prospective as it involved enrolling subjects and following them with the investigational device.

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

   • This was a clinical study involving patients wearing contact lenses, with outcomes measured by eye care practitioners. The text does not specify the number of individual "experts" used to establish ground truth in the sense of adjudication for, for example, image interpretation. However, the study was conducted by clinicians/investigators at multiple sites, presumed to be qualified eye care practitioners. Their qualifications (e.g., ophthalmologists, optometrists, years of experience) are not detailed in this summary.

3. Adjudication method for the test set:

   • The document describes a "multisite, randomized, double masked clinical study." This suggests that the investigators assessing patient outcomes were masked to whether the patient was using the investigational or control lens where possible, reducing bias in assessment. There is no mention of a formal adjudication panel (e.g., 2+1, 3+1) specifically for reviewing clinical outcomes or discrete "ground truth" events. Clinical findings (e.g., slit lamp evaluation, comfort ratings, visual acuity) would have been recorded by the examining clinicians.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a physical medical device (contact lens) and does not involve AI or human readers interpreting cases.

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

   • No. This device is a contact lens and does not involve an algorithm.

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

   • For this contact lens study, the "ground truth" for evaluating performance and safety was derived from clinical outcomes data directly observed and recorded by eye care practitioners during patient visits, supplemented by patient-reported comfort and wearing time. This includes:
     • Slit lamp findings (e.g., injection, staining)
     • Keratometry changes
     • Manifest refraction changes
     • Visual acuity measurements
     • Patient comfort ratings
     • Wearing time
     • Reports of adverse events and complications.

7. The sample size for the training set:

   • This is a contact lens, not an AI/ML device, so there is no "training set" in the context of machine learning. The non-clinical tests involved laboratory characterization of the material.

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

   • Not applicable as there is no training set for an AI/ML algorithm. Material properties were established through standard laboratory testing methods (e.g., ISO, ANSI methods for Dk, transmittance, wetting angle, hardness, modulus, etc., and USP/ISO methods for biological reactivity, toxicity).

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FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I horor chil. 92 ngla ga permission between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphabic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal leases are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as kerator ones, pellucid marginal degeneration, or following penctrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I tobior and out from 1 to 7 days between removals for cleaning and disinfection as recommonded by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact leases are indicated for daily wear only.

FluoroPerm® 60 rigid gas permeable spheric and bifocal contact leases are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfece with visual acuity. FivoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 60 contact leases are indicated for management of irregular comcal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoriasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the cye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS rigid gas permeable spherical, asphenc and bifocal contact lenses are indicated for the correction of visual aculty in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS tone contact leases are indicated to correct astigmatism of up to 6.00 diopters. Faragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratotorny, radial keratotorny, or LASIK surgeryin otherwise nondiseased eyes.

FluoroPerm® 30 rigid gas permeable contact leases are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm* 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up 10 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up 10 6.00 diopters. FluoroPerm* 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 30 contact lenses are indicated for management of irregular comeal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon Thin " rigid gas permeable contact lenses are indicated for daily wear as recommended by the eve care practitioner.

Paragon Thin rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased tyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comes astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" witc contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin bifocal lenses are indicated to treat presbyopia up 10 +4.00 D add power.

Paragon Thin" contact lenses are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerme 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm 151 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased cycs that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPenn® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopers. FluoroPerm 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm 151 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS 100 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual scuity in not-aphakic persons with nondiseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diovers that docs not interfere with visual acuity. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS 100 contact leases are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following peactrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 92, FluoroPerm® 60, Paragon HDS*, FluoroPerm* 30, Paragon Thin"*, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; pastufocon A (FluoroPerm" 02), pallufocon B (FluoroPerm) 60, Paragon HDS®), patlufocon C (Fluorosco (Film The Paragon Time), and Poly San Poly San Parised Bron fluorosilicone acrylate monomers.

The lenses may be tinted to offer a handling and for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17.

The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber, Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2.2'-dihydroxy-4,4'-dimethoxybenzophenone.

The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspherical curves peripheral to the base curve.

I am sorry, but based on the provided document, I cannot generate the requested information about acceptance criteria and a study proving device performance. The document is primarily a 510(k) clearance letter and an "Indications For Use" statement for various rigid gas permeable contact lenses. It does not contain details about specific acceptance criteria or a study that directly demonstrates the device meets such criteria with performance data, sample sizes, ground truth establishment, or expert involvement.

The document discusses the substantial equivalence of the devices to legally marketed predicate devices, which is a regulatory pathway for approval, but it does not present a detailed study as you've outlined.

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FluoroPerm® 92 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permicable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D ad power.

FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 contact lenses are indicated for persons requiring. keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin" rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin"" bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 151 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. F FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS® 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiscased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Keratoconus contact lens designs are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30, Paragon Thin""), and paflufocon D (FluoroPerm® 151. Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17. These products may be plasma treated. The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber. Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2,2'-dihydroxy-4,4'dimethoxybenzophenone. The lens designs have a posterior surface consisting of a base curve and a series of four spherical or aspherical curves progressively flatter than the base curve.

This 510(k) summary is for contact lenses, which are medical devices that do not typically involve AI algorithms or software for diagnosis or analysis. The acceptance criteria and study information provided in such documents relate to the physical properties, safety, and efficacy of the lens materials and designs, usually through bench testing, biocompatibility studies, and clinical trials for safety and performance (e.g., visual acuity correction, physiological response of the eye). Therefore, many of the specifics requested in the prompt related to AI/ML device evaluations (like ground truth, expert adjudication, MRMC studies, training/test sets for algorithms) are not applicable here.

However, I can extract the relevant information regarding the acceptance criteria and how the device generally meets them, based on the provided text, and note where other requests are not applicable.

Acceptance Criteria and Device Performance for FluoroPerm® and Paragon HDS® RGP Contact Lenses

This submission is for a traditional medical device (contact lenses) rather than an AI/ML diagnostic or prognostic tool. Therefore, the "acceptance criteria" and "device performance" relate to the physical and chemical properties of the contact lens materials and their demonstrated safety and efficacy through prior regulatory approvals. The "study" proving acceptance criteria is primarily an assertion of substantial equivalence to a predicate device and reliance on previous PMA approvals for the material safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the materials and the intended use. Performance is reported through material specifications and the claim of substantial equivalence to a legally marketed predicate device.

Note: The keratoconus indication for FluoroPerm® 30 and Paragon Thin™ is explicitly stated as a difference from the predicate in the "Substantial Equivalence Summary Table" (Page 3 of 8), but then indicated within the detailed "Indications For Use" section for all FluoroPerm and Paragon HDS lenses (Pages 1-3, and 6-8). This implies the predicate (Boston® II) did not have a specific keratoconus indication, making the addition of this indication for the new devices a non-trivial aspect of their approval.

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

This is not applicable in the context of an AI/ML medical device. For contact lenses, "test sets" would refer to samples used for physical property testing (e.g., Dk measurements), biocompatibility testing, and clinical trials. The document relies on previous PMA approvals (PMA P870024 and supplements) for the materials' safety and efficacy, meaning the data provenance for the foundational studies would be from those prior submissions, not detailed here. No specific "test set" sample sizes are provided for this 510(k) submission as it relies on substantial equivalence and previously approved materials.

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

This is not applicable as there is no "ground truth" to establish in the AI/ML sense. The approval relies on scientific and clinical data from previous PMA submissions, which would have involved ophthalmic practitioners and scientists.

4. Adjudication Method for the Test Set

Not applicable. There is no AI/ML adjudication process described. Clinical trial results (from prior PMAs) would have been reviewed by regulatory bodies and independent experts.

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 an AI-assisted diagnostic or prognostic device.

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

Not applicable. This is not an AI algorithm. The device is a physical contact lens.

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

Not applicable. The "ground truth" for contact lenses relates to meeting material specifications, biocompatibility, and clinical performance (e.g., visual acuity, comfort, ocular health parameters) as demonstrated in clinical trials and laboratory testing, often against established standards. The document states that "The safety and efficacy... have been demonstrated in PMA P870024 and various of its supplements." This implies that the 'ground truth' or evidence base is derived from comprehensive preclinical (material science, biocompatibility) and clinical outcomes data from those prior PMA studies.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML training set.

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

Not applicable.

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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:

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.

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The SportSight GP (paflufocon C) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The SportSight GP (paflufocon C) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. SportSight GP (paflufocon C) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. SportSight GP bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D. SportSight GP (paflufocon C) contact lenses are indicated for the attenuation of bright light and the reduction of glare. SportSight TM GP (paflufocon C) contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The SportSight GP (paflufocon C) intensely tinted, rigid gas permeable contact lenses are available in SportSight Gray. The Gray tinted lens contains D&C Red # 17, D & C Green No. 6, and Perox Yellow No. 9. The lenses have the following dimensions: Refractive Index 1.466(Nd at 25°C), Luminous Transmittance (driving allowed) 8% - 26%, Luminous Transmittance (driving prohibited) 1% - 8%, Wetting Angle (Receding Angle) 12.81 1.14, Specific Gravity, Hardness (Shore D) 84,

The provided text describes the technical specifications and testing of "SportSight™ GP (paflufocon C)" rigid gas permeable contact lenses, but it does not contain information about a device that uses artificial intelligence (AI) or a study that evaluates its performance against acceptance criteria in the context of AI/ML.

Instead, the document is a 510(k) submission for a traditional medical device (contact lenses) and focuses on demonstrating substantial equivalence to a predicate device and compliance with physical and safety standards. The "acceptance criteria" discussed are product specifications (e.g., light transmittance, UV blocking, material properties) and the "study" is primarily physical testing and biocompatibility assessments, not performance evaluations of an AI algorithm.

Therefore, I cannot provide the requested information about AI acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text.

The information that is available about the device's properties and testing is presented below, aligning with the format requested where applicable for such a device:

Acceptance Criteria and Device Performance (SportSight™ GP Contact Lenses)

The acceptance criteria for the SportSight™ GP contact lenses are primarily based on optical properties and material characteristics, benchmarked against standards like ANSI Z80.3-1996 for Nonprescription Sunglasses and Fashion Eyewear. The study demonstrates that the device meets these criteria through laboratory measurements.

1. Table of Acceptance Criteria and Reported Device Performance

The following table summarizes key performance characteristics based on various lens powers and associated center thicknesses ("Lower", "Recom" - recommended, "Upper", and "Special*"). The acceptance criteria are implicit in the reported values meeting the specified ranges and standards.

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