FLOSI (willofocon A) Rigid Gas Permeable Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for dally wear correction of refractive ametropla (myopla, hyperopla, astigmatism and presbyopla) In aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Device Description

The FLOSI (wilofocon A) Rigid Gas Permeable Contact Lons Is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, willofocon A, is sphencer, asphonour, and assigment which contains D & C Green No: 6 as a color additive. The FLOS (willofocon A) Contact Lens is a hemispherical shell.

AI/ML Overview

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study proving the device meets them:

Device: Flosi (wilofocon A) Rigid Gas Permeable Contact Lens (Spherical, Aspheric, Toric, and Bifocal)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in the provided document. Instead, the study's findings are presented as being "within expecteds" or demonstrating "no significant issues," implying that the performance met acceptable clinical standards for this type of device. Based on the clinical study summary, the implied acceptance criteria revolve around the safety and efficacy of the contact lens, specifically related to potential adverse reactions, visual acuity, slit-lamp findings, and refractive changes.

Acceptance Criteria Category (Implied)	Specific Performance Metric (Implied Target)	Reported Device Performance
Safety - Adverse Reactions	No adverse reactions requiring treatment	None reported
Safety - Slit-Lamp Findings (SLFs)	SLFs within expected range for RGP lenses	99 Grade 1 SLFs (mostly corneal staining, 18% of visits); 5 Grade 2 SLFs (staining, resolved by lens changes). "were within expecteds for wearers of an RGP contact lens."
Safety - Symptoms/Complaints (SPCs)	SPCs within expected range for RGP lenses	135 reports (largest: variable vision 8.7%, lens awareness 6.2%). "All symptoms, problems or complaints were reduced over time. None... can be considered outside of the normal expecteds."
Efficacy - Visual Acuity	No drop in visual acuity greater than one line	"No patients experienced a drop of visual acuity that was greater than one line."
Efficacy - Keratometry	Minimal change in corneal curvature	90.4% showed no change to 0.50 D change; 98.6% showed 1.00 D or less change. Average change: 0.08 D flattening. "generally low and may be attributed to adaptation to a new lens type or usual clinical measurement variation."
Efficacy - Refraction	Minimal change in refractive error	99.1% showed no change to 1.00 D change. Average change: near zero. "generally low and may be attributed to a better fitting lens or usual clinical measurement variation."
Wear Time	Clinically acceptable daily wear time	Average wearing time: 14.9 hours

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

Sample Size for Test Set:
- Clinical Study: 122 eyes enrolled, with 110 eyes completing a minimum of three months of contact lens wear. 12 eyes were discontinued.
- Preclinical Studies:
  - Systemic Injection Test: Animals (number not specified, but typically small groups)
  - Eye Irritation Test: Rabbits (number not specified, but typically small groups)
  - Tissue Culture-Agar Overlay Cytotoxicity Assay: In vitro (not applicable for animal count)
Data Provenance: The document does not specify the country of origin for the clinical study data. Given the submission to the FDA (United States), it is highly probable the study was conducted in the USA or a region with comparable clinical standards. The study appears to be prospective, as it describes enrolling patients and following them over a three-month period of contact lens wear.

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

The document does not specify the number of experts used to establish the ground truth for the clinical test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, clinical studies for medical devices like contact lenses are typically overseen and evaluated by ophthalmologists or optometrists who are experienced in contact lens fitting and management. The observations (slit-lamp findings, keratometry, refraction, visual acuity) would have been performed and recorded by these clinical professionals.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical test set. The clinical findings collected (SLFs, SPCs, keratometry, refraction, visual acuity) are typically direct observations or measurements made by the treating clinician during the study visits. It is implied that the clinical investigators made these assessments and their findings were recorded and aggregated for analysis. There is no mention of a separate panel or process for resolving discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly done. The clinical study described focuses on the performance of the Flosi contact lens on its own, not in comparison to human readers or with AI assistance. It evaluates the device's safety and efficacy in a standalone clinical setting.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was done, if we interpret "standalone" as the device performing its intended function without human intervention beyond fitting and wear. The clinical study specifically evaluates the Flosi contact lens as the standalone device. The lens is placed in the eye, and its performance (visual acuity correction, impact on eye health) is assessed. There is no AI component or algorithm described in this submission; the "device" is the physical contact lens itself.

7. Type of Ground Truth Used

For the clinical study, the "ground truth" was established through direct clinical observations and measurements by eye care professionals. This includes:

Clinical Examination Findings: Slit-lamp examinations for corneal and conjunctival health.
Patient-Reported Outcomes (PROs): Symptoms, problems, and complaints (SPCs).
Objective Measurements: Keratometry (corneal curvature), Refraction (visual correction needed), Visual Acuity (measured using standard charts like Snellen).
Adverse Event Monitoring: Tracking any adverse reactions or significant clinical issues.

For the preclinical studies, the ground truth was based on established laboratory assays and animal model observations (e.g., signs of toxicity, ocular irritation).

8. Sample Size for the Training Set

Not applicable / Not explicitly stated. This device is a physical contact lens, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a device would reside in the historical data and scientific principles used during its design and material formulation, but this is not a data set in the sense of AI.

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

Not applicable. As mentioned above, there is no AI/ML training set defined for this physical device. The "ground truth" for the development of any medical device comes from scientific understanding, clinical experience with similar devices, regulatory standards, and extensive pre-clinical and clinical testing, which includes the safety and efficacy data presented in this submission.

Summary

{0}------------------------------------------------

K 974636

ﺍﯾﮏ ﮐﮯ ﮐﺎ ﺭﻗﺒﮧ 197

ുക്കും.

അവലംബം

MAR 30 1998

COMPREHENSIVE SUMMARY III.

{1}------------------------------------------------

K974636

NAME AND USE OF DEVICE

Device Generic Name:	wilofocon A
Device Trade Name:	Flosi rigid gas permeable contact lens
Indications:	Flosi rigid gas permeable contact lenses areIndicated for daily wear correction of visualacuity In aphakic and not-aphakic personswith non-diseased eyes who are nearsighted(myopic), farsighted (hyperopic), presbyopicor who have corneal astigmatism.
Alrperm 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 Fiosi rigid gas permeable contact lensmust be disinfected using only a chemical (notheat) disinfection system as recommended.

{2}------------------------------------------------

K97463k

VI. DEVICE CHARACTERISTICS

LENS PARAMETERS AVAILABLE

•Diameter	6.5 to 11.5 mm
•Center Thickness
for Low Minus Lens:	0.05 to 0.30 mm
for Plus Lens:	0.10 to 0.70 mm
•Base Curve	6.50 to 9.00 mm
•Powers	-20.00 to +20.00 Diopters
•Aspheric Lens Eccentricity	-1.5 to 1.5
Oblate to Prolate
Feripheral Curves	0.1 to 10 mm. Flatter or Steeper thanBase Curve
•Toric Lens
Axis	1 to 180 degrees in 1 degree steps
Cylinder power	0.50 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 Transmittance
Clear (370-760 nm)	93%
Tinted (D & C Green No. 6) (380-780 nm)	87%
•Surface Character	Hydrophobic
•Wetting Angle (CLMA Method)	23.0 ± 2
•Water Content (Gravimetric method at 22°C)	<1%
•Oxygen Permeability	Dk 26 x 10-11 at 35°C(cm²/sec) (ml 02 /ml x mmHg) Polarographic methodof Fatt (1990)
•Hardness (Shore)	89

{3}------------------------------------------------

K974636

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

IIIB. PRECLINICAL STUDIES

Systemic Injection Test In Mice

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.

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 tissues of the test animals.

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 obsevable 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 Flosi (wilofocon) Rigid Gas Permeable Contact Lens Polymer is nontoxic.

IIIC. CLINICAL STUDIES

All eves enrolled in the study were accounted for. A total of 122 eyes 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 comeal staining (77 reports or 18% of all visits). The staining at 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

{4}------------------------------------------------

K974636

attributed to the fact that 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 eye 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 eye 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 98.6 percent of the eye 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 eye 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 contact 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 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 cvlindrical 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.

A comparison was made between the best corrected visual Visual Acuity: 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

{5}------------------------------------------------

K974636

merit comment. Visual acuity results when wearing Flosi 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.

Conclusion:

There were no eyes that experienced adverse reactions, SLFs requiring treatment or SPCs requiring treatment. The FLOSI 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.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the department's logo in the center. The logo is a stylized representation of a human figure with three arms, symbolizing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 30 1998

Dr. William Platt Futuristic Design Associates 1 Avalon Road Mount Vernon, OH 43050

Re: K974636

Trade Name: Flosi (Wilofocon A) Rigid Gas Permeable Contact Lenses for Daily Wear (Spherical, Aspheric, Toric and Bifocal) Clear and Tinted (with D&C Green #6) Regulatory Class: II

Product Code: 86 HQD Dated: March 11, 1998 Received: March 12, 1998

Dear Dr. Platt:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are 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 devices 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 devices 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.

{7}------------------------------------------------

Page 2 - Dr. William Platt

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

If you desire specific advice for your devices 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 devices, 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

{8}------------------------------------------------

510(k) Number: K974636

Application Number:

Device Name: FLOSI (wilotocon A) Rigld Gas Permeable Spherical, Aspherical, 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)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K974636

Prescription Use	✓	OR	Over-The-Counter Use
(Par 21 CFR 801.109)			(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.