The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes.

Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Device Description

Soft contact lenses are hemispherical shells manufactured of a copolymer of 2hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolldone (NVP), which yield the appearance of lenses, which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6 mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

AI/ML Overview

This document is a 510(k) Summary for a contact lens device, not a study report describing acceptance criteria and performance data. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present.

However, I can extract the information provided about the device's technical specifications and how its "substantial equivalence" to a predicate device serves as the basis for its market acceptance.

This document does not contain information about:

Acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for a study.
A study proving the device meets acceptance criteria.
Sample sizes for test or training sets.
Data provenance (country of origin, retrospective/prospective).
Number/qualifications of experts used for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance.
Type of ground truth used (pathology, outcomes data, etc.) for a study.
How ground truth for a training set was established.

Information Extractable from the Provided Document:

1. A table of acceptance criteria and the reported device performance:

The acceptance for this device is based on "substantial equivalence" to a legally marketed predicate device. The document does not describe performance metrics in the way one would for an AI/algorithm-based device (e.g., accuracy, sensitivity, specificity). Instead, it compares the physical, optical, and chemical properties, material, indications for use, and method of manufacture to the predicate device. The "acceptance criteria" here are effectively that these characteristics are sufficiently similar to the predicate to establish substantial equivalence.

Parameter	Acceptance Criteria (Predicate Device: Flexlens Hydrophilic Contact Lens for Daily Wear)	Reported Device Performance (Specialty 42 Hydrophilic Contact Lens for Daily Wear)
Material	hefilcon A	hefilcon A
Indication for Use	myopia, hyperopia and astigmatism	myopia and hyperopia (Note: Toric version also covers astigmatism)
Water Content	42%	42%
Light Transmittance	>95%	>95%
Dk (35° C)	13.13 X 10-11	13.25 X 10-11
Powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters
Color	clear	clear and blue visibility
Specific Gravity	1.044	1.031
Refractive Index	1.413	1.417
Method of Manufacture	Lathe cut	Lathe cut
FDA Material Grouping	Group 1 (low water, non-ionic polymers)	Group 1 (low water, non-ionic polymers)
Disinfection Systems	(Implicitly similar for Group 1 material)	Heat, chemical or hydrogen peroxide disinfection systems
Wear Modality	Daily Wear	Daily Wear
Replacement Program	(Implicitly similar for Daily Wear)	Frequent Replacement program with scheduled replacement

2. Sample sized used for the test set and the data provenance:

Not applicable. This is a contact lens submission based on substantial equivalence, not an AI/algorithm study with test sets and data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for a test set is not mentioned as this is a device clearance based on substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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-assisted device.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this type of device (contact lens), the "ground truth" for "acceptance" is its physical, chemical, and optical properties and its intended use, which are verified against a predicate device and established material classifications (e.g., FDA Group 1 for materials). There isn't a "ground truth" in the diagnostic or prognostic sense.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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NOV 2 0 1997 K973192

510 (k) Summary

SUBMITTER:

Company: Specialty UltraVision, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008
Contact Person: Ivalee Cohen Director, Regulatory and Clinical Affairs

Telephone: 408-341-0700 408-341-0717 FAX:

Date Prepared: November 17, 1997

DEVICE NAME:

Common Name:	Soft Contact Lens
Trade Names:	Specialty 42 (hefilcon A) Hydrophilic Contact Lens forDaily Wear (clear and visibility tinted)
	Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lensfor Daily Wear (clear and visibility tinted)

FDA Classification: Class II

SUBSTANTIALLY EQUIVALENT TO:

Flexlens (hefilcon A) Hydrophilic Contact Lens for Daily Wear, Paragon Vision Sciences Flexlens Toric (hefilcon A) Hydrophilic Contact Lens for Daily Wear, Paragon Vision Sciences

Specialty 42 (hefilcon A) Hydrophilic Contact Lens for Daily Wear and tinted) and Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens for Daily Wear (clear and visibility tinted) are substantially equivalent in physical, optical and chemical properties, as well as material of manufacture, indications for use and method of manufacture to Paragon Vision Sciences' Flexlens (hefilcon A) Hydrophilic Contact Lens for Daily Wear and Flexlens Toric (hefilcon A). Flexiens lenses received marketing approval pursuant to N17-976. Specialty UltraVision, Inc. has received from the manufacturer of the hefilcon A contact lens buttons, BENZ Research and Development Corp., the right to reference their master file (MAF 872) and 510(k) K972807 regarding the manufacture and distribution of this material.

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The hefilcon A lens material has been placed in Group 1, low water, and non-ionic polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition, May, 1994.

DESCRIPTION OF THE DEVICE:

PARAMETER	Specialty 42 HydrophilicContact Lens for Daily Wear(clear and visibility tinted)	Flexlens HydrophilicContact Lens for Daily Wear
material	hefilcon A	hefilcon A
indication for use	myopia and hyperopia	myopia, hyperopia andastigmatism
water content	42%	42%
light transmittance	>95%	>95%
Dk (35° C)	13.25 X 10-11	13.13 X 10-11
powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters
color	clear and blue visibility	clear
specific gravity	1.031	1.044
refractive index	1.417	1.413
Method ofmanufacture	Lathe cut	Lathe cut

SIMILARITIES AND DIFFERENCES

INDICATIONS FOR USE:

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PARAMETERS AVAILABLE:

. . . . .

Specialty 42 (hefilcon A) Hydrophilic Contact Lens (clear and visibility tinted)

Powers:	+20.00 to -20.00 Diopters
Diameter:	14.3 mm
Base Curve:	8.6 mm

Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens (clear and visibility tinted)

Powers:	+1.00 to -7.00 Diopters
Diameter:	14.5 mm
Base Curve:	8.3 mm, 8.6 mm. And 8.9 mm
Cylinder powers:	-0.75, -1.25, -1.75, -2.25, -2.75, -3.25 Diopters
Axes:	10°, 20°, 80°, 100°, 160°, 170°, 180°

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, forming a single abstract shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Ms. Ivalee Cohen Director of regulatory and Clinical Affairs Specialty Ultra Vision, Inc. 84 West Main Street Freehold, NJ 07728

Re: K973192

Trade Name: Specialty 42 (hefilcon A) Hydrophilic Contact Lens for Daily Wear and Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens for Daily Wear (clear and visibility tinted, lathe cut) -------------

Regulatory Class: II Product Code: 86 LPL Dated: August 18, 1997 Received: August 25, 1997

Dear Ms. Cohen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. -----------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Ivalee Cohen

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS STATEMENT

510(k) Numbør: K973192

Device Name:

Specialty 42 (hefilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted)

Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens for Daily Wear (clear and visibility tinted)

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-GONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use_

Daniel W. C. Brown, Ph.D. 8

(Optional Format 1-2-96)

(Division Sign-Off) Division of Ophthalmic Devices K973192 510(k) Number.

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.