The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eves that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Device Description

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is tinted using D & C Green #6 in an in-monomer tinting process.

AI/ML Overview

The provided text describes a 510(k) submission for a soft contact lens and does not contain information about a device that uses AI or requires a study with expert review, ground truth establishment, or MRMC studies. The text focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physicochemical properties and safety.

Therefore, I cannot fulfill the request to describe acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not relevant to the provided content.

Here's a breakdown of what is available in the document regarding "acceptance criteria" (more accurately, comparative criteria) and the "study" (non-clinical testing for substantial equivalence):

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

The document presents a comparison between the new device and its predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are essentially that the new device's parameters are comparable to those of the predicate device.

PARAMETER	Acceptance Criteria (Predicate Device)	Reported Device Performance (New Device)
Material	methafilcon A	methafilcon A
Material Classification	Hydrophilic Lens Group 4	Hydrophilic Lens Group 4
Indication for Use	myopia, hyperopia	myopia, hyperopia
Water Content	55%	55%
Light Transmittance	Approximately 98%	Approximately 98%
Dk (35° C)	18.8 x 10 -11	18.8 x 10 -11
Powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters
Color	blue visibility	blue visibility
Refractive Index	1.42	1.42
Specific Gravity	1.06	1.06
Method of Manufacture	Molded	Molded
Tint	D&C Green #6 (Note: Predicate lists "D&C Green #6" while the new device description lists "D & C Green #6" and the comparison table lists "Vat Blue #6" for the predicate. This seems like a discrepancy in the provided text. For consistency with the summary, D&C Green #6 is used for the new device and assume consistency with predicate for this table based on the summary statement)	D&C Green #6
Tint Process	Entrapment process during polymerization	Entrapment process during polymerization
Cytotoxicity	Non-cytotoxic (implied by predicate's safety)	Non-cytotoxic (reported for new device)
Leachability	No detectable tint level (implied by predicate's safety)	No detectable level of tint in test extracts (reported for new device)

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

The document describes non-clinical testing rather than a typical "test set" for an algorithm.

Sample Size: Not explicitly stated for specific tests (e.g., how many lenses were tested for Dk, water content, etc.). The statement "Results of cytotoxicity testing show the lens material to be non-cytotoxic. the physicochemical properties of the lens to be comparable to the predicate device, and the leachability testing demonstrates no detectable level of tint in the test extracts." implies that sufficient samples were tested to assert these properties.
Data Provenance: The testing was "conducted in accordance to the Premarket Notification 510(k) Guidance Document for Class II Contact Lenses issued by FDA in May, 1994." This implies controlled laboratory testing, not patient data from specific countries or retrospective/prospective studies.

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

This is not applicable to this type of device submission. There is no "ground truth" to be established by experts as it's a physical medical device (contact lens) assessed through material and performance testing against established standards and comparisons to a predicate device, not through interpretation of data by human experts.

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

This is not applicable as there is no "test set" in the context of expert review or image interpretation. The evaluation is based on laboratory test results.

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:

This is not applicable. This is a contact lens, not an AI-powered diagnostic device.

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

This is not applicable. This is a contact lens, not an algorithm.

7. The type of ground truth used:

The "ground truth" for affirming the device's properties is based on physicochemical testing standards and results, and cytotoxicity/leachability assays, compared directly to a legally marketed predicate device as per FDA guidelines for Class II contact lenses.

8. The sample size for the training set:

This is not applicable. There is no "training set" for a physical medical device like a contact lens.

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

This is not applicable.

Summary

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2 2000 FEB

Image /page/0/Picture/1 description: The image shows the words "SPECIALTY" and "ULTRAVISION INC." stacked on top of each other. The word "SPECIALTY" is in a sans-serif font and is slightly blurred. The words "ULTRAVISION INC." are in a serif font and are much clearer. The word "ULTRAVISION" is much larger than the word "INC."

K 993580

510(k) Summary

Submitter Information:

Specialty UltraVision, Inc. 307 Orchard City Drive, Suite 100 Campbell, CA 95008 Garold Edwards, O.D., F.A.A.O. Contact Person: Vice President, Technical Affairs (408) 341-0700 Telephone: Fax: (408) 341-0717

Date Prepared: October 19, 1999

Device Name:

Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Names:	Specialty 55 (methafilcon A) Soft (Hydrophilic) SingleVision Contact Lens for Daily Wear
Classification Name:	Soft (Hydrophilic) Contact Lens
Device Classification:	Class II (21 CFR 886.5925)

Predicate Devices:

The Specialty 55 (methafilcon A) Soft Single Vision Contact Lens for Daily Wear was selected as the predicate device. This device, which was cleared under 510(k) K984090, is manufactured from the same polymer and the same lens design.

Description of Devices:

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Comparison to Predicate Device

PARAMETER	Specialty 55 (methafilcon A)Soft (Hydrophilic) SingleVision Contact Lens for DailyWear	Specialty 55 (methafilcon A)Soft (Hydrophilic) SingleVision Contact Lens for DailyWear
material	methafilcon A	methafilcon A
material classification	Hydrophilic Lens Group 4	Hydrophilic Lens Group 4
indication for use	myopia, hyperopia	myopia, hyperopia
water content	55%	55%
light transmittance	Approximately 98%	Approximately 98%
Dk (35° C)	18.8 x 10 -11	18.8 x 10 -11
powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters
color	blue visibility	blue visibility
refractive index	1.42	1.42
specific gravity	1.06	1.06
Method of manufacture	Molded	Molded
Tint	D&C Green #6	Vat Blue #6
Tint process	Entrapment process duringpolymerization	Entrapment process duringpolymerization

Indications for Use:

Description of Safety and Substantial Equivalence:

Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device, and to establish the safety and effectiveness of the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear. All testing was conducted in accordance to the Premarket Notification 510(k) Guidance Document for Class II Contact Lenses issued by FDA in May, 1994. Results of cytotoxicity testing show the lens material to be non-cytotoxic. the physicochemical properties of the lens to be comparable to the predicate device, and the leachability testing demonstrates no detectable level of tint in the test extracts.

Conclusion:

Information submitted in the 510(k) establishes that the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear has comparable physicochemical properties to the predicate device and does not raise questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like shapes above a wavy line, symbolizing health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2000 FEB

Garold L. Edwards, O.D. Vice President, Technical Affairs Specialty Ultravision, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008

Re: K993580

Trade Name: Specialty 55 (methafilcon A) Soft (hydrophilic) Single Vision Lens For Daily Wear (cast-molded, visitint with D & C Green #6)

Regulatory Class: II Product Code: 86 LPL Dated: January 14, 2000 Received: January 18, 2000

Dear Dr. Edwards:

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 - Garold L. Edwards, O.D.

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

Device Name:

Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear

Indications for Use:

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__ Over-the-Counter Use OR

E.S. Co. Ph.D.
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K 993580

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.