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The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia or extreme photophobia. The lenses may be disinfected using chemical disinfection systems.

Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are daily wear soft contact lenses for use in enhancing or altering the apparent color of the eye for prosthetic and theatrical use. The lenses used to produce Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are Benz 38 (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (Clear) supplied by Benz Research & Development of Sarasota, Florida. These lenses have received FDA premarket clearance (K961103). The Benz 38 lens material is polymacon, which in the hydrated state consists of 62% hydrophilic polymer of 2-hydroxyethylmethacrylate (2-HEMA) and 38% water. The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are made by incorporating by hand an opaque pigment in an iris pattern between two layers of the polymacon polymer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo performance criteria for a novel device. Therefore, the "acceptance criteria" discussed are primarily about meeting the safety and effectiveness standards implied by the predicate devices and general regulatory requirements for contact lenses.

Acceptance Criteria and Reported Device Performance

• Toxicology Testing: Passed Acute Eye Irritation, Cytotoxicity, and Systemic Toxicity tests, demonstrating they are "non-toxic." |
  | Structural Integrity (Pigment Incorporation) | - Interface Bonding: Tests "verified the integrity of the interface bonding of the sandwich-configuration of the lenses."
• Surface Smoothness: Due to pigment incorporation method, "the internal and external lens surface remains smooth." (Implied safety - no irritation from pigment contact) |
  | Substantial Equivalence to Predicate Devices (Key Properties) | - Material: Polymacon, nonionic polymer, 38% water content (matches Aspect Vision Natural Touch).
• Light Transmission: > 95% (Comparable to predicate devices: Natural Touch > 97%, Ciba Vision Illusions 75.6 to 98%).
• Dk (Oxygen Permeability): 9 (Comparable to predicate devices: Natural Touch 8 x 10⁻¹¹, Ciba Vision Illusions 9).
• Refractive Index: 1.43 (hydrated) (Comparable to predicate devices: Natural Touch 1.44, Ciba Vision Illusions 1.43).
• Powers: +20 to -20 (Broader range than some predicates, but within general contact lens capabilities). |
  | Intended Use Compatibility | - Indicated for daily wear, ocular masking, correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons, and occlusive therapy. (Supported by material safety and comparison to predicates with similar uses). |
  | Disinfection Compatibility | - May be disinfected using chemical disinfection systems. (Implied capability based on material and comparison to predicates). |

Study Details

The document describes performance testing rather than a full "study" in the sense of a clinical trial with a defined test set and ground truth established by experts.

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

   • Sample Size: Not explicitly stated for any of the performance tests (dye leachability, toxicology, interface bonding). The document refers to "tests were conducted," implying a sufficient number of samples were used to generate reliable results for these specific engineering/material property evaluations.
   • Data Provenance: Not explicitly stated. Given it's a submission by Contact Color Srl in Italy, the testing was likely conducted in Europe or at laboratories contracted by the manufacturer. It is retrospective data, meaning it was collected prior to this 510(k) submission.

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

   • This type of information is not applicable to the performance testing described. The tests are material property and safety evaluations (e.g., chemical leachability, cytotoxicity assays), not diagnostic or clinical accuracy studies that would require expert human interpretation for ground truth. The "ground truth" for these tests would be objective scientific measurements against established laboratory standards or protocols.

3. Adjudication method for the test set:

   • Not applicable. As explained above, these are objective laboratory tests, not subjective interpretations requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an AI-powered diagnostic or assistive technology. Such a study would be irrelevant to its intended use and regulatory pathway.

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

   • Not applicable. This is a medical device (contact lens), not an algorithm.

6. The type of ground truth used:

   • For the described performance tests (dye leachability, toxicology, interface bonding), the "ground truth" is based on objective laboratory measurements and validated scientific protocols for material safety and integrity, as well as adherence to recognized standards for biocompatibility testing. There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for these specific tests.

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm requiring a training set.

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

   • Not applicable. No training set is involved.

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