Oxycon (wilofocon A) Rigid Gas Permeable, Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and nonaphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Device Description

The Oxycon (wilofocon A) Rigid Gas Permeable Contact Lens is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, wilofocon A, is a fluoro silicone acrylate polymer which contains D&C Green No. 6 as a color additive. The Oxycon (wilofocon A) Contact Lens is a hemispherical shell.

AI/ML Overview

The provided text describes the characteristics of the Oxycon™ RGP Contact Lens and a clinical study conducted to support its safety and effectiveness. However, it does not explicitly define specific numerical acceptance criteria for device performance (e.g., "visual acuity must improve by X lines for Y% of patients"). Instead, the study reports observed outcomes and concludes whether these outcomes are within "expecteds" for RGP contact lens wearers.

Therefore, I will interpret "acceptance criteria" based on the qualitative conclusions drawn from the clinical study, as these represent the implicit criteria for the device's acceptance. The reported device performance will be derived directly from the study's findings.

Acceptance Criteria and Reported Device Performance (Oxycon™ RGP Contact Lens)

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

Acceptance Criteria Category	Qualitative Acceptance Criteria (Inferred from Study Conclusions)	Reported Device Performance (from Clinical Study)
Safety (Adverse Events)	No adverse reactions requiring treatment.	"There were no eyes that experienced adverse reactions, SLFs requiring treatment or SPCs requiring treatment."
Safety (Slit-Lamp Findings - SLFs)	Slit-lamp findings (e.g., corneal staining, injection) should be within expected ranges for RGP lens wearers and resolve with lens changes if Grade 2.	Total of 99 Grade 1 SLFs (mostly corneal staining, 18% of visits). 5 Grade 2 SLFs (all staining), resolved by lens changes. "The total number of slit-lamp findings were within expecteds for wearers of an RGP contact lens."
Safety (Symptoms, Problems, Complaints - SPCs)	Symptoms, problems, or complaints (e.g., variable vision, lens awareness) should be within expected ranges for RGP lens wearers and reduce over time.	Total of 135 SPC reports (variable vision 8.7%, lens awareness 6.2%). "All symptoms, problems or complaints were reduced over time." "None of the categories for symptoms, problems, and complaints can be considered outside of the normal expecteds for a rigid gas permeable contact lens."
Effectiveness (Keratometry)	Keratometry changes should be generally low and attributable to adaptation or measurement variation.	Majority (90.4%) showed no change to 0.50 diopters change. 90.6% showed 1.00 diopter or less change. Average change of 0.08 diopters flattening. 3 patients showed >1.00 diopter change (two -1.25 D, one +1.25 D), with no change in 20/20 VA. "The changes in keratometry were generally low and may be attributed to adaptation to a new lens type or usual clinical measurement variation."
Effectiveness (Refraction)	Refraction changes should be generally low and attributable to better fit or measurement variation.	Majority (99.1%) showed no change to 1.00 diopters change. Average change near zero. 2 patients showed >1.00 diopter change (one +1.50 D sphere, one -1.50 D cylinder in both eyes). These had no change in 20/20 VA. "The changes in refraction were generally low and may be attributed to a better fitting lens or usual clinical measurement variation."
Effectiveness (Visual Acuity)	No patient should experience a drop in visual acuity greater than one line.	"There were no patients who experienced a drop of visual acuity that was greater than one line during the course of this study." "Visual acuity results when wearing Oxycon Rigid Gas Permeable Contact Lenses during the course of this investigation were found to be within expecteds."
Wearing Time	Acceptable average daily wearing time.	Average wearing time achieved at the end of the study was 14.9 hours.
Overall Safety & Wearability	Device shown to be worn safely.	"The Oxycon rigid gas permeable contact lens was shown to be worn safely by all patient eyes in this study including those that completed (110 eyes) and discontinued (12 eyes) the study."

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

Sample size for the test set: A total of 122 eyes were enrolled in the clinical study. 110 eyes completed at least three months of wear, and 12 eyes were discontinued.
Data provenance: The data is from a prospective clinical study. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or under U.S. regulatory standards.

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

The document does not explicitly state the number or qualifications of medical experts (e.g., ophthalmologists, optometrists) who conducted the clinical examinations to establish the "ground truth" (i.e., measured outcomes) for the test set. It implies that trained clinical staff performed the assessments (e.g., slit-lamp examinations, keratometry, refraction, visual acuity checks).

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

The document does not describe any specific adjudication method for the test set data (e.g., multiple independent readers reviewing cases to resolve discrepancies). The clinical data seems to be collected and reported by the attending clinical investigator(s).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a contact lens, not an AI-powered diagnostic or assistive device. Therefore, there is no discussion of human readers improving with or without AI assistance.

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

No, a standalone performance study (algorithm only) was not done. This study assesses the performance of a physical contact lens worn by human subjects, not an algorithm.

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

The "ground truth" for the device's performance was established through direct clinical observation and measurement of physiological and visual parameters in human subjects by clinical investigators. This includes:

Visual acuity measurements
Slit-lamp examination findings (for corneal staining, injection, etc.)
Subjective patient reports of symptoms, problems, and complaints (SPCs)
Keratometry measurements
Refraction measurements

These are "outcomes data" derived from clinical examinations rather than expert consensus on retrospective images or pathology reports.

8. The sample size for the training set

The document describes a clinical study for device approval. It does not mention a "training set" in the context of an algorithmic or AI-based device. The 122 enrolled eyes constitute the clinical study population used to demonstrate safety and effectiveness.

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

As there is no mention of a "training set" in the context of an algorithmic device, this question is not applicable to the provided document. The clinical study was designed to evaluate the physical contact lens directly in patients.

Summary

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Submitted by:

Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street NW (Suite 700) Washington, DC 20036

On behalf of Con-Cise Contact Lens Co., Inc. 510(k) Submission: Oxycon™ RGP Contact Lens

Device Classification:	Rigid Gas Permeable Contact Lens (21 CFR 886.5916)
Predicate Device:	Oxycon Rigid Gas Permeable Contact Lens (K974636)
	* *
NAME AND USE OF DEVICE
Device Generic Name:	wilofocon A
Device Trade Name:	Oxycon rigid gas permeable contact lens
Indications:	Oxycon rigid gas permeable contact lensesare indicated for daily wear correction ofvisual acuity in aphakic and non-aphakicpersons with non-diseased eyes who arenearsighted (myopic), farsighted (hyperopic),presbyopic or have corneal astigmatism.
Airperm Ranges:	Chord diameter 6.5 to 11.5 mmCenter thickness 0.05 to 0.70 mmBase Curve 6.50 to 9.00 mmPowers -20.00 to +20.00 diopters
Cleaning and Disinfection:	The Oxycon rigid gas permeable contact lensmust be disinfected using only a chemical(not heat) disinfection system asrecommended.

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DEVICE CHARACTERISTICS

LENS PARAMETERS AVAILABLE

* Diameter	6.5 to 11.5 mm
* Center Thicknessfor Low Minus Lens:for Plus Lens:	0.05 to 0.30 mm0.10 to 0.70 mm
* Base Curve	6.50 to 9.00 mm
* Powers	-20.00 to +20.00 Diopters
*Aspheric Lens EccentricityOblate to Prolate	- 1.5 to 1.5
Peripheral Curves	0.1 to 10 mm. Flatter or Steeper than Base Curve
* Toric LensAxisCylinder power	1 to 180 degrees in 1 degree steps0.50 to 4.00 Diopters
The physical/optical properties of the lens are:
* Specific Gravity	1.25
* Refractive Index (589 nm at 25°C)	1.44
* Light TransmittanceClear (370-760 nm)Tinted (D&C Green No. 6) (380-780 nm)	93%87%
* Surface Character	Hydrophobic
* Wetting Angle (CLMA Method)	23.0 ± 2
* Water Content (Gravimetric method at 22°C)	<1%
* Oxygen Permeability(cm²/sec) (ml O₂/ml x mm Hg) Polarographic method of Fatt (1990)	Dk 26 x 10-11 at 35°C
* Hardness (Shore)	80

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Exhibit 4 Page 3

SUMMARY OF STUDIES Oxycon (wilofocon A) Rigid Gas Permeable Contact Lens

PRECLINICAL STUDIES

Systemic Injection Test in Mice 1.

The test is based on the FDA guidelines entitled "Testing Guidelines for Class II Contact Lenses. April 1989," and the United States Pharmacopeia XXII, National Formulary XVII. None of the test and control animals exhibited overt signs of toxicity at any of the observation points and hence the test material is considered non-toxic.

2. Eye Irritation Test in Rabbits

The test is based on the FDA guidelines entitled "Testing Guidelines for Class III Contact Lenses, April 1989." The extract of test contact lenses was evaluated for the potential to produce ocular irritation over a 72 hour period. The test article did not cause any significant irritation to the ocular tissue of the test animals.

က် Tissue Culture-Agar Overlay Cytotoxicity Assay

The assay is based on that described in USP and National Formulary. The contact lens blanks did not cause any observable cytotoxic effects when tested according to the procedures outlined in the study report and is therefore considered non-cytotoxic.

Based on the results of the preclinical testing it is reasonable to assume that the Oxycon (wilofocon) Rigid Gas Permeable Contact Lens Polymer is non-toxic.

CLINICAL STUDIES

All eyes enrolled in the study were accounted for. A total of 122 eves were enrolled in the study. A total of 110 eyes completed a minimum of three months of contact lens wear, 0 eyes were incomplete and 12 eyes were discontinued. The largest number of patients enrolled in this study (92.7%) were previous wearers of rigid gas permeable contact lenses. The average age was 37 years. During the three-month course of this study there were a total of 428 scheduled and 38 unscheduled eye visits.

Slit-Lamp: There was a total of 99 reports of Grade 1 SLFs of which the largest number was for corneal staining (77 reports or 18% of all visits). The staining at

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the follow-up visits was nearly all of the type three and nine o'clock staining, which was also present at the initial visit. The next most common slit lamp findings were for injection, which included 15 reports or 3.5% of the visits. There were five reports of grade 2 findings, all for staining and which were resolved by lens changes.

The total number of slit-lamp findings were within expecteds for wearers of an RGP contact lens. The large number of reports for corneal staining can be attributed to the fact hat most patients were previous rigid lens wearers who entered the study with three and nine o'clock staining. During the time that lenses were worn by the discontinued patients there were no slit lamp findings reported.

SPCs: There were a total of 135 reports of symptoms, problems or complaints for the 356 eve visits during the three-month course of this study. The largest number of complaints (8.7%) was for variable vision, followed by lens awareness (6.2%). All symptoms, problems or complaints were reduced over time. None of the categories for symptoms, problems, and complaints can be considered outside of the normal expecteds for a rigid gas permeable contact lens.

Keratometry: The majority of the eve meridians (90.4%) showed no change to 0.50 diopters change over the course of this investigation. Changes of 1.00 diopter or less were found in 90.6% of the eve meridians. The number of changes were nearly equal for those who had increased or decreased power which resulted in an average change of 0.08 diopters flattening. In the three patients who experienced a change of greater than 1.00 diopter, two eye meridians showed a decrease of 1.25 diopters and one meridian showed an increase of 1.25 diopters. The changes in keratometry were generally low and may be attributed to adaptation to a new lens type or usual clinical measurement variation. The three patients who showed changes in one eye meridian of 1.25 diopters all had no change in their normal visual acuity of 20/20 and no significant signs or symptoms.

Refraction: the majority of the eyes (99.1%) showed no change to 1.00 diopters change over the course of this investigation. The number of spherical and cylindrical changes were nearly equal for those who had increased or decreased power, which resulted in an average change of near zero. In the two patients who experienced a change of greater than 1.00 diopter, one (306) showed a spherical change in the left eye of 1.50 diopters. One patient (505) showed a cylindrical decrease in both eyes of 1.50 diopters, which was attributed to a better fit of the test lens than was the case for the lens worn prior to the study. The changes in refraction were generally low and may be attributed to a better fitting lens or usual clinical measurement variation. The three eyes that showed changes of 1,50 diopters all had no change in their normal visual acuity of 20/20 and no significant

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signs or symptoms. For the patients who discontinued, the 12 test eyes showed no change to 0.50 diopters change over the course of this investigation. The number of spherical and cylindrical changes were nearly equal for those who had increased or decreased power. The changes in refractive sphere and cylinder were generally low and may be attributed to normal variation in the findings.

Visual Acuity: A comparison was made between the best corrected visual acuity at the initial examination to the visual acuity when wearing contact lenses at the final examination. There were no patients who experienced a drop of visual acuity that was greater than one line during the course of this study. Two patients had reduced visual acuity both initially and at the end of this study and merit comment. Visual acuity results when wearing Oxycon Rigid Gas Permeable Contact Lenses during the course of this investigation were found to be within expecteds. No patients experienced a drop of visual acuity that was greater than one line.

The average wearing time achieved at the end of the study was 14.9 hours.

Conclusions:

There were no eyes that experienced adverse reactions, SLFs requiring treatment or SPCs requiring treatment. The Oxycon rigid gas permeable contact lens was shown to be worn safely by all patient eyes in this study including those that completed (110 eyes) and discontinued (12 eyes) the study.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1999

Mr. Daniel J. Manelli Representative for Con-Cise Contact Lens Co. 2000 M Street NW, Suite 700 Washington, DC 20036

Re: K990895 Trade Name: Oxycon™ Lens Regulatory Class: II Product Code: 86 HQD Dated: March 16, 1999 Received: March 17, 1999

Dear Mr. Manelli:

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 -- Mr. Daniel J. Manelli

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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EXHIBIT 2

Page 1 of 1

510(k) Number (if known): K 99 0895

Oxycon (wilofocon A) Rigid Gas Permeable Spherical, Aspherical, Device Name: Toric, and Bifocal Contact Lenses

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zorfele

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_k99 o 895

Prescription use
(Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

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.