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The OPTIMUM GP OK contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6. C.I. Solvent yellow No. 18. and FD&C Red No. 17.

In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm – 315nm and 95% in the UVA range of 316 – 380nm.

The provided text is a 510(k) summary for the OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens. It does not describe a study that uses acceptance criteria in the manner typically associated with AI/ML device performance evaluations. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed clinical or technical study with specific performance metrics and acceptance thresholds for a novel device function.

Therefore, many of the requested fields cannot be directly extracted or are not applicable from this type of regulatory document.

However, I can extract information related to product specifications and a comparison to predicate devices, which serve a similar purpose in demonstrating that the new device is "as good as" existing, cleared devices.

Here's an attempt to answer the questions based on the provided text, while noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the context of a statistical study with performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic test. Instead, it demonstrates substantial equivalence by comparing the physical and chemical properties and indications for use of the proposed device to legally marketed predicate devices. The "performance" here is that its characteristics are similar enough to existing devices to not raise new questions of safety and effectiveness.

Here's a table comparing key characteristics of the subject device with its predicates, as presented in the document:

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 refers to demonstrating "safety" through K033594, which itself encompasses "Clinical Performance" for the material (roflufocon D & E). However, this document does not describe a new clinical study. It leverages prior clearance of the material and the intended use.
Therefore, there is no explicit "test set" sample size or data provenance mentioned for a new study within this 510(k) submission.

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)

Not applicable. This is not a study requiring expert-established ground truth for a test set.

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

Not applicable. There is no test set or adjudication method described.

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 contact lens, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. This device is a contact lens, not an algorithm.

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

Not applicable. The clearance is based on substantial equivalence to predicate devices, not on a new study requiring a defined ground truth. Previous clearances (K033594 for material safety, K973697 and K071266 for orthokeratology indication and design) would have involved their own safety and effectiveness data, likely including outcomes data from clinical trials for contact lenses (e.g., visual acuity, corneal health, adverse events) to support their original clearance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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