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The Acuity 85™ (oprifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, bresbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D for daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.

The Acuity 85™ (oprifocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for sphere
• with base curves of 4.0 mm to 11.50 mm
• with base curve chord of 6.0 mm to 6.5 mm
• with diameter of 7.0 to 21.0 mm
  The lens material (oprifocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material.

The provided document is a 510(k) Summary for the Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, which seeks to establish substantial equivalence to a predicate device. As such, it does not detail a study involving AI or human readers, or clinical trials with acceptance criteria for device performance in the way a new medical device would typically be evaluated for accuracy or diagnostic capability.

Instead, the "acceptance criteria" here refers to demonstrating that the new device's material properties and design are substantially equivalent to a legally marketed predicate device, as per FDA guidelines for daily wear contact lenses. The "study" mentioned is primarily non-clinical testing of the material properties.

Here's a breakdown based on the information provided, framed to address your specific questions where applicable, and noting where information is not relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by the properties of the predicate device (Boston Equalens II) and the "performance" is the new device's (Acuity 85) equivalent properties. The goal is to show the new device meets or is comparable to the predicate's established properties.

Note: The differences in Refractive Index, Oxygen Permeability, Specific Gravity, Hardness, and Modulus between the new and predicate device are considered acceptable for demonstrating substantial equivalence for this type of device, falling within expected manufacturing variations or improvements that do not raise new questions of safety or effectiveness. For example, a higher oxygen permeability is generally considered an improvement for contact lenses.

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

This submission relies on non-clinical testing of the lens material. The sample size for material testing is not explicitly stated in the document, but it would typically involve multiple batches or samples of the material to ensure consistency. The provenance is internal to Acuity Polymers, Inc., where the oprifocon A lens material is manufactured. This is laboratory testing, not human subject data, so "retrospective" or "prospective" as applied to clinical studies is not relevant here.

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 type of submission does not involve "experts" establishing ground truth in the context of diagnostic interpretation. The "ground truth" for material properties is established by standardized laboratory testing methods and measurements (e.g., ISO standards or internal validated methods). The document states the material testing meets ISO 10993-1 (2009) for biocompatibility and FDA Daily Wear Contact Lens Guidance Document standards. The staff performing these tests would be qualified laboratory technicians and scientists, but their number and specific qualifications are not detailed in this summary.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of medical images or patient outcomes. This is not relevant to the non-clinical material testing conducted for this 510(k) submission.

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 MRMC comparative effectiveness study was done, as this submission is for a contact lens material and design, not an AI-powered diagnostic device. The concept of "human readers improve with AI" is not applicable here.

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

No standalone algorithm performance study was done. This device is a physical contact lens, not a software algorithm.

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

The "ground truth" in this context refers to the objectively measured chemical, mechanical, and optical characteristics of the oprifocon A material and the finished lens, obtained through established laboratory testing protocols. These metrics are then compared to the established properties of the predicate device material and design, as well as relevant guidance documents (e.g., FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009)).

8. The sample size for the training set

This submission did not involve a "training set" in the context of machine learning or deep learning algorithms. It concerns the substantial equivalence of a medical device (contact lens) based on material properties and design.

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

As there was no training set for an algorithm, this question is not applicable. The "ground truth" for the material characteristics was established through laboratory testing and conformity to existing standards and predicate device properties.

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