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The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

The alternate designs of the Menicon Z (tisilfocon A) contact lens are bifocal and trifocal design contact lenses. Conventional bifocal / trifocal designs are employed in the alternate designs of Menicon Z (tisilfocon A) rigid gas permeable contact lenses. The lens material, tisilfocon A, is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is classified fluoro-silicone acrylate, group III, page 16, FDA's premarket notification (510(k)) guidance document for daily wear contact lenses. May 12. 1994. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (2-(5-Chloro-2Hbenzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol)) is added.

The provided text describes a 510(k) summary for alternate designs (bifocal and trifocal) of the Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens. The submission aims to demonstrate substantial equivalence to the previously cleared spherical design of the same lens.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the alternate designs or report specific numerical performance metrics for these new designs. Instead, it relies on demonstrating substantial equivalence to the spherical design, which had already undergone testing.

The acceptance criteria for the spherical design were implicitly met by showing that "the clinical findings i.e., adverse reactions, positive slit lamp findings, patient symptoms, problems and complaints, visual acuity, lens replacements, discontinued patients, lens wearing time and keratometry changes were within the expected limits for daily wear lens wearers."

For the alternate designs (bifocal/trifocal), the acceptance criteria for substantial equivalence appears to be that their characteristics are comparable to the predicate (spherical) device, and they are as safe and effective, not raising different types of safety and effectiveness questions. The document does not provide specific comparative performance data for the alternate designs against these criteria.

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

• Test Set (for Spherical Design): The text mentions a "randomized, controlled clinical trial" for the spherical design where "subjects were randomly assigned in a two-to-one ratio to the spherical design of the Menicon Z™ Rigid Gas Permeable Contact Lens and to that of the Menicon SF-PTM Rigid Gas Permeable Contact Lens." However, the exact sample size of subjects is not provided.
• Data Provenance: Not explicitly stated, but the applicant's address is Nagoya, Japan, and the contact person is from Menicon U.S.A. Inc. It's common for clinical trials supporting 510(k)s to be conducted in the country of the applicant or in multiple countries. Given the 1997 date, detailed provenance might not have been as routinely reported in 510(k) summaries as today. The study was prospective as it was a "randomized, controlled clinical trial."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The clinical trial focused on general clinical findings and adverse events, which are typically assessed by treating practitioners (e.g., ophthalmologists, optometrists), but details on expert panels for ground truth determination are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned. The clinical trial was focused on comparing the Menicon Z spherical design against another Menicon lens (SF-P) through direct patient outcomes, not on assessing human reader performance with or without an AI device. The device itself (contact lens) is not an AI diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used (for Spherical Design Clinical Trial)

The ground truth was based on clinical findings and patient outcomes observed during the randomized controlled trial. This includes:

• Adverse reactions
• Positive slit lamp findings (clinical examination)
• Patient symptoms, problems, and complaints (patient-reported)
• Visual acuity (objective measurement)
• Lens replacements (clinical event data)
• Discontinued patients (clinical event data)
• Lens wearing time (patient-reported or clinical record)
• Keratometry changes (objective measurement)

8. Sample Size for the Training Set

• Not applicable. This is a medical device (contact lens), not an AI/ML algorithm that requires a training set. The "training" for the lens itself would be its manufacturing process.

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

• Not applicable. As above, there is no AI/ML training set.

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