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BENZ 38 (polymacon) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50' Diopters of astigmatism where it does not interfere with visual acuity.

BENZ 38 (polymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-The spherical lenses are being applied for diseased eyes. from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.

BENZ 38 (polymacon) lens can be lathed into a spherical soft (hydrophilic) contact lens which becomes a hemispherical shell. The non-ionic material, hioxifilcon A is an ultra high molecular weight homo-polymer of 2-hydroxyethyl methrylate (2-HEMA). This material is made from extremely high purity monomer using state of the art polymer synthesis technique. It consists of 62% hioxifilcon A and 38% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

The lens made from BENZ 38 (polymacon) when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina. BENZ 38 with the visibility tint was subjected to leeching tests and showed no identifiable evidence of leeching.

The clear BENZ 38 (polymacon) optical buttons are identical to the polymacon optical buttons made by Benz Research and development in PMA P830012/S04 approved June 5, 1990. The pigment used in the BENZ-38 Blue Visibility tinted buttons and in BENZ-38 blue visibility tinted lenses is identical to the pigment used in K952620 BENZ-G 55 (hioxifilcon A) Class II Soft(hydrophilic) contact lenses Class 86-IPL, approved DEC. 1, 1995.

This document is a 510(k) notification for a contact lens material (BENZ 38 polymacon), not a device that relies on AI algorithms, human readers, or expert adjudication for its performance. Therefore, many of the requested elements for an AI/ML-based device study are not applicable.

However, I can extract information related to the device performance and the studies conducted to demonstrate safety and effectiveness for this type of medical device (contact lenses).

Here's the information, adapted to fit the context of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for specific tests (e.g., toxicology, microbiology, clinical studies). It refers to studies conducted for previous approvals (P830012/S04 in 1990 for clear lenses and K952620 in 1995 for pigment similarity).

• Sample Size: Not specified in the provided text.
• Data Provenance: Studies were conducted by Benz Research and Development, Inc. and Unilens Corp. USA. The data is retrospective in the sense that it relies on previously conducted and approved studies for the base material (clear) and the pigment (visibility tint). No specific country of origin for the human subjects or specimens is mentioned, but the companies are US-based.

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

This concept is not directly applicable to a contact lens material approval. "Ground truth" in this context would be established by laboratory testing methods and clinical observations, not by expert consensus on interpretations of images or data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for contact lens material approval is based on:

• Laboratory Bench Testing: This includes toxicology assays, microbiology testing, lens compatibility tests, preservative uptake tests, and leeching tests, which produce objective measurements and results.
• Clinical Study Outcomes: Observations of patient safety, comfort, and visual acuity in human subjects wearing the lenses. These are typically assessed against pre-defined safety and efficacy endpoints.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device. The "training set" concept doesn't apply here; rather, the material's properties are established through a series of physical, chemical, and biological tests.

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

Not applicable. As above, this is not an AI/ML device. The "ground truth" for the material's performance relies on rigorous testing protocols and accepted scientific methodologies for contact lens materials, rather than a "training set" in the AI sense.

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