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The Marietta Contact Lens (polymacon), Tinted Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visua acuity.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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 ler may be cleaned and disinfected using a chemical (not heat) lens care system.

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution.

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.

As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additive effect is formed by reacting one or more of the color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.

This document is a 510(k) summary for a contact lens (Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens). The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device meets acceptance criteria through a clinical study with specific performance metrics like those for AI/ML devices. Therefore, the provided text does not contain explicit acceptance criteria and a study demonstrating performance against those criteria in the way you might expect for an AI/ML device.

However, I can extract the relevant information from the document to infer the acceptance criteria and how the device demonstrated "performance" for its regulatory pathway.

Here's an attempt to answer your request based on the provided document, adapting the terminology to fit the context of a 510(k) for a contact lens:

Description of Acceptance Criteria and Study for the Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens

This submission is a 510(k) for a modified contact lens, demonstrating substantial equivalence to pre-existing predicate devices. As such, the "acceptance criteria" are primarily established by the characteristics and safety profile of the predicate devices, and the "study" is a comparison and verification that the modified device maintains these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the characteristics of the predicate devices. The "reported device performance" is a demonstration that the modified device meets or is comparable to these characteristics.

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

Since this is a 510(k) for a contact lens, the "test set" does not refer to a dataset for an algorithm. Instead, it refers to the physical lenses and potentially human subjects used in biocompatibility, physical property, and clinical performance testing (though detailed clinical study results are not provided in this summary). The document does not specify a sample size for any in vivo testing. The data provenance would be from Marietta Vision's internal testing and comparison to their own predicate devices. It is implicit that any human subject testing would be prospective, though details are not provided.

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

This concept is not applicable here. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for this medical device submission. The "truth" for physical and chemical properties of a contact lens is established through validated laboratory testing methods. Clinical performance and safety are typically assessed by optometrists/ophthalmologists, but no specific "ground truth" expert panel is mentioned as would be for an AI diagnostic device.

4. Adjudication Method for the Test Set

This concept is not applicable. There's no interpretive test set requiring adjudication in the way an AI diagnostic device would.

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

This is not applicable. The device is a contact lens, not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" involved in its direct function.

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

This is not applicable as the device is a physical contact lens, not an algorithm.

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

The "ground truth" for this device's characteristics is based on established physical, chemical, and biological testing methods for contact lenses, and comparison to the known properties and safety profiles of previously cleared predicate devices (their own Addvantage 38 (Polymacon), K942302 and Marietta Contact Lens, color enhanced, K002647). For safety and clinical performance, the ground truth would be based on clinical observations and established ophthalmic standards.

8. The Sample Size for the Training Set

This is not applicable as the device is a contact lens, not an AI model requiring a training set.

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

This is not applicable as the device is a contact lens, not an AI model.

Summary of the "Study" from the Document:

The "study" or justification for equivalence in this 510(k) is primarily a technological characteristics comparison (as presented in the table on page 3) between the modified device and its predicate devices. This comparison demonstrates that:

• The Intended Use, Functionality, Indications, Production Method, FDA Group #, USAN Name, and Water Uptake (%) are identical to the predicate devices.
• The Sterility Assurance Level (SAL) is $10^{-6}$, which aligns with one predicate and indicates a sterile product, satisfying safety requirements.
• The material composition (polymacon, 2-HEMA, EGDMA, initiator, 38% water) is the same.
• The modification strictly involves the incorporation of specific, listed reactive color additives to the anterior surface, which are stated to be thoroughly washed and not to alter the original characteristics of the lens except for light transmittance.
• New physical properties for the tinted version (Light Transmission >90%, Oxygen Permeability 8.4 X 10-11) are provided, implicitly demonstrating that these are within acceptable ranges for a safe and effective contact lens of this type.

The core argument for acceptance is substantial equivalence to existing, legally marketed predicate devices, meaning the modified device is as safe and effective as the predicates and does not raise new questions of safety or effectiveness.

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