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The CONTAFLEX 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting 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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The CONTAFLEX 38 Spherical Soft Contact Lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. 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 co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The polymacon name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTAFLEX 38 (polymacon) Spherical Soft Contact Lens:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device ("BENZ 38") rather than defining explicit, separate acceptance criteria for the new device. The "acceptance criteria" are implied by the need for the CONTAFLEX 38 to exhibit comparable pre-clinical characteristics to the BENZ 38.

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

The document describes preclinical testing to demonstrate the safety and effectiveness of the material. However, it does not provide specific sample sizes or information about the provenance (country of origin, retrospective/prospective) for these preclinical tests. The tests mentioned are:

• In-Vitro Cytotoxicity (ISO 10993-5): No sample size specified.
• Systemic Toxicity: No sample size specified.
• Acute Ocular Irritation: No sample size specified.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical performance or diagnostic accuracy. The studies described are pre-clinical material characterization and toxicology studies.

4. Adjudication Method for the Test Set:

Not applicable. The studies described are preclinical and do not involve human interpretation or adjudication of test results in the way a clinical diagnostic study 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:

Not applicable. This is a pre-clinical submission for a medical device (contact lens material), not an AI-powered diagnostic system. No MRMC study was conducted or is relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an AI-driven device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" for the preclinical studies would be established by the results of the standardized biological and physical tests themselves, as per the specified test methodologies (e.g., ISO 10993-5 for cytotoxicity). For material properties (water content, oxygen permeability, specific gravity), the "ground truth" is derived from direct measurements using recognized scientific methods.

8. The Sample Size for the Training Set:

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set described in the document.

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