MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS by MENICON U.S.A., INC.

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.

Device Description

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.

AI/ML Overview

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."

Acceptance Criteria Category (for Spherical Design)	Reported Device Performance (for Spherical Design)
Adverse reactions	Within expected limits for daily wear lens wearers
Positive slit lamp findings	Within expected limits for daily wear lens wearers
Patient symptoms, problems and complaints	Within expected limits for daily wear lens wearers
Visual acuity	Within expected limits for daily wear lens wearers
Lens replacements	Within expected limits for daily wear lens wearers
Discontinued patients	Within expected limits for daily wear lens wearers
Lens wearing time	Within expected limits for daily wear lens wearers
Keratometry changes	Within expected limits for daily wear lens wearers
Microbiological safety	Supported by non-clinical testing
Toxicological safety	Supported by non-clinical testing
Chemistry	Supported by non-clinical testing
Manufacturing standards	Supported by non-clinical testing

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.

Summary

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K970019

MAR 2 5 1997

VI 510(k) Summary for the Alternate Designs of Menicon Z™ ( tisilfocon A ) Rigid Gas Permeable Contact Lens

Menicon Co., Ltd. Applicant's Name and Address: 21-19, Aoi 3-Chome Naka-ku, Nagoya 460 Japan Phone 011 81 52 937 5021 011 81 52 935 1121 Fax

Contact Person:

Mr. Taiji Higaki President Menicon U.S.A. Inc. 333 West Pontiac Way Clovis, CA 93612

Summary Prepared

December 27, 1996

Trade Name:

Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens Bifocal design contact lens Trifocal design contact lens

Device Generic Name:

tisilfocon A ( rigid gas permeable contact lens )

Classification Name :

Rigid gas permeable contact lens

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Predicate Device:

The spherical design lens of the Menicon ZTM ( tisilfocon A ) Rigid Gas Permeable Contact Lens

Device Description:

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.

Indications for Use:

Substantial Equivalence:

The alternate designs of the Menicon Z (tisilfocon A) contact lens are substantially equivalent to the spherical design of the Menicon Z (tisilfocon A) contact lens, which is a lens with an existing USAN

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The applicant performed non-clinical and clinical testing on the spherical design of the Menicon Z (tisilfocon A) contact lens in accordance with the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses (May, 1994).

The non-clinical testing supports the safety and effectiveness of the device from microbiological, toxicological, chemistry, and manufacturing perspectives. The applicant sponsored a randomized, controlled clinical trial in which 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.

It was determined 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.

Conclusion:

The alternate designs of the Menicon Z (tisilfocon A) contact lens are a class II medical device. The information submitted in the 510(k) notification established the device is substantially equivalent to the spherical design of the Menicon Z (tisilfocon A) contact lens in that the device has the comparable characteristics as the predicate device and is as safe and effective as the predicate device and does not raise different types of safety and effective questions.

117

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.