Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.

Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal corneal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.

The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.

The lens may be disinfected using a chemical disinfection system only.

Device Description

The Menicon Z™ lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents.

The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

AI/ML Overview

This 510(k) summary describes a rigid gas permeable contact lens, not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria, as well as several other elements of the prompt (such as number of experts, adjudication method, AI improvement, training set size, etc.), are not applicable to this document. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices.

However, based on the information provided, here's an attempt to answer the relevant aspects of your request regarding acceptance criteria and the "study" that proves the device meets them, interpreting "acceptance criteria" as meeting the chemical and physical properties of similar, already-approved devices, and "study" as the comparison of these properties:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the properties of the predicate devices. The Menicon Z™ rigid gas permeable contact lens is considered to meet these criteria if its material properties are comparable to those of the predicate devices.

Property	Acceptance Criteria (Based on Predicate Devices)	Menicon Z (TISILFOCON A)
Specific Gravity	Range of 1.19 - 1.27 (from Boston XO2, XO, Equalens II)	1.20
Refractive Index	Range of 1.423 - 1.425 (from Boston XO2, XO, Equalens II)	1.436
Visible Light Transmittance	≥70% (from Boston Equalens II), 83-92% (from Boston XO2, XO)	>95%
Water Content	<1% (from Boston XO2, XO, Equalens II)	<0.5%
Oxygen Permeability (Dk)	Range of 85-141 (polarographic) & 100-140 (gas-to-gas) (from Boston XO2, XO, Equalens II)	189 (gas-to-gas method)163 (polarographic method)*

*Note: The Menicon Z™ Dk values are higher than the predicate examples, which is generally considered an advantage for contact lenses.

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

Test Set Sample Size: Not applicable. This submission relies on material property comparisons and prior clearances, not a clinical test set in the traditional sense for an AI/ML device.
Data Provenance: The data provided (material properties) are intrinsic to the device material and are likely derived from laboratory testing conducted by Menicon Co., Ltd. The document does not specify the country of origin of this specific material data or if it's retrospective/prospective outside of the general timeframe of the predicate device clearances.

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

Not applicable. Ground truth, in the context of an AI/ML device, is not established for this type of submission. The "ground truth" for material properties would be the measured values determined by standardized laboratory methods.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring expert adjudication.

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 this submission are the measured physical and optical properties of the Menicon Z™ material, which are compared against those of already cleared predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and thus there is no training set.

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

Not applicable. As there is no training set.

Summary

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510(k) summary MENICON Z ™ (tisilfocon A) RIGID GAS PERMEABLE CONTACT LENSES February 2011

FEB - 3 2011

1. Applicant Information

Menicon Co., Ltd. 21-19, Aoi 3-chome, Naka-ku, Nagoya, Aichi 460-0006 JAPAN Contact Person: Takahiro Ochi Telephone No.: 481-52-935-1676 Fax No.: +81-52-935-1633

E-mail: t-ochi@menicon-net.co.jp

2. Device Information

Classification name: Lenses, Rigid Gas Permeable, Daily Wear Contact Lenses Device classification: Class II Regulation number: 21 CFR 886.5916 Product code: HQD Proprietary name: Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses

3. Predicate Devices

Menicon claims substantial equivalence of the Menicon ZTM (tisilfocon A) to the following predicate devices.

1. Menicon Z ™ (tisilfocon A) Rigid Gas Permeable Contact Lenses (K962006, K970019, K081443)
1. Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lenses (K071266)
1. Boston XO (hexafocon A) Rigid Gas Permeable Contact Lenses (K071043)
1. Boston Equalens II (oprifocon A) (K022128) (Rigid Gas Permeable Contact Lenses

4. Description of device

The Menicon Z™ lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents.

The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

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5. Indications for use

Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses in all diameters are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.

Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal lenses in diameters ≤ 12.0 mm are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.

The lens may be disinfected using a chemical disinfection system only.

6. Description of safety and substantial equivalence

The safety and efficacy of the Menicon Z ™ (tisilfocon A) Rigid Gas Permeable Contact Lens material was demonstrated in 510(k) Premarket Notifications as follows.

K962006 cleared on October 9, 1996 .
K970019 cleared on March 25, 1997 (multifocal designs) .
K081443 cleared on September 23, 2008 (irregular corneas/postsurgical)

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Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to

Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses for already . approved indications and designs (as noted above).
Boston XO2 (hexafocon B) (K071266), Boston XO (hexafocon A) . (K071043) and Boston Equalens II (oprifocon A) (K022128) (Rigid Gas Permeable Contact Lenses for indications for use, material properties, lens designs in diameters up to 21 mm, manufacturing/packaging methods and biocompatibility.

The indication for use for the lenses is for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. Additionally, the Menicon Z, Boston XO and Boston XO2 lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The following table compares the physical/optical properties of the Menicon Z material with the predicate lens materials:

Property	Menicon Z	Boston XO	Boston XO2	BostonEqualens II
Specific Gravity	1.20	1.27	1.19	1.24
Refractive Index	1.436	1.425	1.424	1.423
Visible Light Transmittance	>95%	92% Average	83-90%	≥70%
Water Content	<0.5%	<1%	<1%	<1%
Oxygen Permeability (Dk***)	189163*	140100*	141	85**

gas to gas method

polarographic method (ISO)

(cm2/sec)(mL O2 / (mL x mmHg) @35℃ (unit)

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Substantial equivalence is further supported by the fact that the Menicon Z and predicate devices are composed of fluoro silicone acrylate polymers, have similar manufacturing and packaging methods, are provided non-sterile and have demonstrated biocompatibility based on the requirements stated in the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994.

7. Clinical data:

Clinical study data for the Menicon Z™ (tisilfocon A) material in large diameters have been deemed as not necessary in support of this clearance, as no new or additional questions of safety or effectiveness have been raised.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

Food and Drug Administration 19903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Foresight Regulatory Strategies, inc. c/o Dr. Beverly D. Venuti, R.A.C. Staff Consultant 187 Ballardvale Street, Suite 180 Wilmington, MA 01887-4461

FEB - 3 201

Rc: K103561

Trade/Device Name: Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Pemeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: December 3, 2010 Received: December 6, 2010

Dear Dr. Venuti:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indictions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical in microal in microadc devices that have been reclassified in accordance with the provisions of the Fedral Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, include of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not maching.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Beverly D. Venuti, R.A.C.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-11050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kusia Alexander

/ Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K103561
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Device Name: Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lenses

Indications for Use:

The lens may be disinfected using a chemical disinfection system only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arina Postell

Page 1 of 1

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103561

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.