The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic or not-aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.

Device Description

The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The EpiCon K Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
Chord Diameter: 10.5 mm to 14.0 mm
Center Thickness: 0.10 mm to 0.35 mm
Base Curve: 6.0 to 8.5 mm
Powers: Plano to -20.00 D
Peripheral Curves: A. B. C. D. E. F and G

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document describes a 510(k) submission for a Rigid Gas Permeable Contact Lens (EpiCon K) and focuses on demonstrating substantial equivalence to a predicate device (UltraCon S). As such, the structure of the document does not explicitly present "acceptance criteria" in the format one might expect for a novel AI/software medical device. Instead, it argues that the new device's performance is "within the expected range" and "substantially equivalent" to the predicate, based on a clinical evaluation.

Therefore, the response below adapts the requested categories to fit the information presented in this specific 510(k) summary, interpreting "acceptance criteria" as the performance metrics and expected ranges for a contact lens for keratoconus patients.

Acceptance Criteria and Device Performance for EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric (Acceptance Criterion - Inferred)	Reported Device Performance (EpiCon K)
Incidence of positive slit lamp findings (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Incidence of subject symptoms (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Incidence of problems and complaints (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Keratometry changes (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Refractive changes (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Visual acuity with the lens (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Lens wearing time (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Lens comfort (within expected range for keratoconic eyes wearing RGP lenses)	Within the expected range
Adverse reactions	Two reported, both resolved without sequelae upon discontinuation of lens wear.
Clinical performance	Substantially equivalent to the predicate lens (UltraCon S Rigid Gas Permeable Contact Lens).

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

Sample Size (Test Set): 38 keratoconic subjects were initially dispensed the EpiCon K lens. 18 subjects (47.4%) completed the 4-week study period.
Data Provenance: The study was a prospective clinical evaluation conducted at five investigational sites, implied to be within the US, as this is an FDA 510(k) submission.

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

This type of information is not explicitly stated in the provided document. For a clinical study of contact lenses, qualified optometrists or ophthalmologists at each investigational site would have performed the examinations and made clinical judgments, but their specific number, roles in establishing "ground truth," or detailed qualifications (e.g., years of experience) are not provided. The study design implies that clinical observations and measurements from these practitioners served as the data for performance evaluation.

4. Adjudication Method for the Test Set

This information is not explicitly stated. The document mentions that the study was conducted "in accordance with current Good Clinical Practices," which would typically include procedures for data collection and review, but a specific adjudication method (e.g., 2+1) is not detailed. The evaluation likely relied on direct clinical assessments by the investigators at each site.

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 document describes the clinical evaluation of a contact lens, not an AI/software medical device. Therefore, an MRMC study related to AI assistance is not relevant or applicable to this submission.

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

Not Applicable. As noted above, this device is a physical contact lens, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the EpiCon K lens was based on clinical observations, measurements, and patient-reported symptoms by trained ocular health professionals (e.g., optometrists, ophthalmologists) during the 4-week clinical evaluation. This includes:

Slit lamp findings
Subject symptom reports
Complaints/problems
Keratometry readings
Refractive measurements
Visual acuity assessments
Lens wearing time
Lens comfort assessments

Comparison was also made against the expected range for keratoconic eyes wearing RGP lenses and against the clinical performance of a predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device (contact lens) and not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant to the described device.

Summary

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Image /page/0/Picture/2 description: The image shows the word "ULTRAVISION" in large, bold, black letters. Below the word "ULTRAVISION" is the abbreviation "INC." in smaller, black letters. The font appears to be a serif font. The background is white.

510(k) Summary

Company:	Specialty UltraVision, Inc.307 Orchard City Drive, Suite 100Campbell, CA 95008
Contact:	Garold L. Edwards, O.D., F.A.A.O.Vice President. Technical Affairs

Telephone: (408) 341-0700 Fax: (408) 341-0717

Date Prepared: December 6, 1999

Device Name:

Common Name:	Rigid Gas Permeable Contact Lens
Trade/Proprietary Names:	EpiCon K (carbosilfocon A) Rigid GasPermeable Contact Lens for Daily Wear

Classification Name: Rigid Gas Permeable Contact Lens

Device Classification: Class II (21 CFR 886.5916)

Predicate Device:

The predicate device is the UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear, which was cleared under 510(k) K980197. This device was selected as the predicate device because it is manufactured from the same polymer, using similar lens designs, at the same manufacturing facility, under the same Quality System and using the same manufacturing equipment.

Description of Device:

. Chord Diameter: 10.5 mm to 14.0 mm
- Center Thickness: 0.10 mm to 0.35 mm
Base Curve:

6.0 to 8.5 mm

Plano to-20.00 D
Powers: . . Peripheral Curves: A. B. C. D. E. F and G

1323 44™ AVENUE N.E. CALGARY, ALBERTA CANADA T2E 6L5 TEL: 800-668-9251 403-291-1919 FAX: 403-291-6477

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Comparison to Predicate Device

PARAMETER	EpiCon K Rigid GasPermeable Contact Lens forDaily Wear	UltraCon S Rigid GasPermeable Contact Lens forDaily Wear
material	carbosilfocon A	carbosilfocon A
materialclassification	Hydrophobic Lens Group 2	Hydrophobic Lens Group 2
indication for use	myopia, hyperopia andastigmatism	myopia, hyperopia andastigmatism
water content	0.5%	0.5%
light transmittance	96.5%	96.5%
Dk (35° C)	52 x 10-11	52 x 10-11
powers	Plano to -20.00 Diopters	+20.00 to -20.00 Diopters
color	blue visibility	blue visibility
specific gravity	1.105	1.105
refractive index	1.49 at 20°	1.49 at 20°
wetting angle	< 19°	< 19°
Method ofmanufacture	Gel Flow Molding	Gel Flow Molding

Indications for Use:

The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.

Description of Safety and Substantial Equivalence:

Biocompatibility, toxicology, physicochemical and leachability studies were previously performed on the carbosilfocon A polymer and cleared under K980197. Results of that testing indicate that the lens material is non-toxic and biocompatible.

Clinical Testing:

A four week clinical evaluation of the EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear was performed at five investigational sites in accordance with current Good Clinical Practices and established regulations. The study assessed the clinical performance of the EpiCon K lens in subjects with bilateral keratoconus. Subjects were seen at an Initial Visit. which was a diagnostic fitting visit. Subjects were seen at a Dispensing Visit, and after 1, 2 and 4 weeks of lens wear. The EpiCon K lens was dispensed to 38 keratoconic subjects, and 18 subjects (47.4%) completed the 4 weeks of the study period while 20 subjects (52.6%) discontinued. Two adverse reactions were reported during the study period, both of which resolved without sequelae upon discontinuation of lens wear.

Based on the clinical data analysis, it was determined that the incidence of positive slit lamp findings, subject symptoms, problems and complaints, keratometry and refractive changes, visual acuity with the lens, lens wearing time and lens comfort were within the expected range for keratoconic eyes wearing RGP lenses.

Clinical performance of the EpiCon K lens was substantially equivalent to the clinical performance of the predicate lens.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized human figure with three lines representing the head, body, and legs. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2000 FEB

Gerald L. Edwards, O.D., F.A.A.O. Vice President, Technical Affairs Specialty UltraVision, Inc. 307 Orchard City Drive, Suite 100 Campbell, California 95008

Re: K992787

Trade Name: EpiCon K (Carbosilifocon A) Rigid Gas Permeable Contact Lens for Daily Wear (Keratoconus Design) Regulatory Class: Class II Product Code: 86HQD Dated: December 6, 1999 Received: December 7, 1999

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 legally marketed predicate 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 verity 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 - Gerald L. Edwards, O.D., F.A.A.O.

· 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,

・

ARalph 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:

EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear

Indications for Use:

(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

Linda Dee Cohn, MD

510(k) Nur

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.