The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear.

Device Description

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

. in the power range of -20.00 to +20.00 diopters for spheres
with base curves of 4.0 mm to 11.50 mm
with base curve chord of 6.0 mm to 6.5 mm ●
with diameters of 7.0 to 21.0 mm ●
The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the performance of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.

Here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format that would typically be seen for an AI device (e.g., target accuracy, sensitivity, specificity thresholds). Instead, the study aims to demonstrate substantial equivalence to a predicate device (Acuity 100). The "acceptance criteria" are implied by the comparison to the predicate device in terms of safety and effectiveness endpoints.

Metric / Endpoint	Acceptance Criteria (Implicit for Substantial Equivalence to Acuity 100)	Reported Device Performance (Acuity 200™)
Effectiveness - Visual Acuity	Substantially equivalent to Control lenses (Acuity 100)	Test and control lenses performed similarly with respect to contact lens corrected visual acuity results.
Safety - Objective Findings (Slit lamp: staining, edema, vascularization, hyperemia, infiltrates, other complications)	No severity worse than Grade 2 (except for isolated instances permitted in predicate)	None of the completed or discontinued eyes in the test arm reported a severity worse than Grade 2 for these findings.
Safety - Subjective Symptoms (Discomfort, Dryness, Irritation)	Incidence and severity similar to Control lenses (Acuity 100)	Test and control lenses performed similarly with respect to subject reported symptoms. Symptoms reported with highest frequency (discomfort, dryness, irritation) showed no clinical difference in incidence between test and control arms.
Safety - Adverse Events	Incidence and severity similar to Control lenses (Acuity 100)	Adverse events that occurred in the study were similar in both arms, in terms of incidence and severity.
Safety - Vision Safety Measures (Keratometry changes, Refractive changes, Best corrected visual acuity)	No clinically relevant differences or negative trends compared to Control lenses (Acuity 100)	The test and control lenses performed equally well with regards to vision safety measures. Trend analysis shows no emerging trends for test and control lenses for the duration of the study.
Biocompatibility	Meets ISO 10993-1:2018 standards for biological evaluation.	Evaluation conducted according to ISO 10993-1:2018. Tests performed include Cytotoxicity, Systemic Toxicity, Ocular Irritation, and Skin Sensitization. Device found to show biocompatibility for a surface device, limited contact.
Performance Testing (Lens/solution compatibility, Manufacturing verification, Extractable testing, Contact angle, Dry shelf life, Lens stability testing)	Meets required performance standards for safety and intended function.	These tests were performed to establish the performance of the device. The non-clinical data demonstrates the safety of the device and demonstrates that the device should perform as intended.

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

Test Set Sample Size: 74 subjects (148 eyes) were enrolled.
- 50 subjects (100 eyes) were in the test group (Acuity 200™).
- 24 subjects (48 eyes) were in the control group (Acuity 100).
- 58 subjects completed the scheduled visits (40 in test group, 18 in control group).
Data Provenance:
- Country of origin: United States. Subjects were evaluated at four independent clinical sites across the United States.
- Retrospective or Prospective: Prospective. The study design is described as an "open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days."

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

This document describes a clinical study for a contact lens, not an AI/ML device relying on expert-annotated ground truth for image analysis. Therefore, the concept of "experts used to establish ground truth" in the AI sense (e.g., radiologists marking images) does not directly apply here.

The "ground truth" for this study is derived from:

Objective clinical measurements: Slit lamp observations (staining, edema, vascularization, hyperemia, infiltrates), keratometry, refractive changes, best corrected visual acuity, adverse event reporting. These are direct measurements/observations by licensed healthcare professionals at the clinical sites.
Subjective patient reporting: Symptoms (discomfort, dryness, irritation), problems, and complaints.

The qualifications of the clinicians performing these assessments are not explicitly stated beyond them being affiliated with "four independent clinical sites."

4. Adjudication method for the test set:

Not applicable in the typical AI/ML context of image interpretation. The study is a clinical trial with observational and measurement endpoints. Data was collected by clinicians at study sites. There's no mention of an independent adjudication panel reviewing discrepancies in diagnoses or measurements in the way one would for an AI ground truth dataset.

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 a clinical trial for a physical medical device (contact lens), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical medical device; there is no "algorithm only" performance.

7. The type of ground truth used:

As explained in point 3, the "ground truth" for this clinical study consists of:

Objective Clinical Findings: Slit lamp observations, keratometry, refractive changes, visual acuity measurements.
Subjective Patient Outcomes/Symptoms: Self-reported discomfort, dryness, irritation, problems, and complaints.
Adverse Event Data: Documented adverse events.

This is fundamentally an outcomes data and expert clinical observation driven ground truth, rather than pathology or image-based consensus in an AI context.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning model development. The "training" for such a device would refer to its manufacturing process development and quality control, which is implied by the non-clinical performance testing.

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

Not applicable, as there is no machine learning training set in this submission. The non-clinical performance data (biocompatibility, lens/solution compatibility, manufacturing verification, extractable testing, contact angle, dry shelf life, lens stability testing) are established through standard laboratory and manufacturing evaluation processes.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 8, 2020

Acuity Polymers. Inc. James A. Bonafini, Jr. President & COO 1667 Lake Avenue, Suite 354 Rochester, NY 14615

Re: K201194

Trade/Device Name: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: August 3. 2020 Received: August 5, 2020

Dear James A. Bonafini, Jr .:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K201194

Device Name

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) SUMMARY

SUBMITTER

Date Prepared:	April 30, 2020
Name and Address:	Acuity Polymers, Inc.1667 Lake Avenue, Suite 354Rochester, NY 14615(585) 458-8409
Contact Persons:	James A. Bonafini, Jr. PresidentTelephone: (585) 458-8409E-Mail: Jim.bonafini@acuitypolymers.com
Consultant:	Bret AndreEyeReg Consulting6119 Canter Ln.West Linn, OR 97068Telephone: (503) 372-5226
DEVICE
Common Name:	Daily Wear Contact Lens
Proprietary Name:	Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Device Classification:	Lenses, Rigid Gas Permeable, Daily Wear Contact Lens; Class II(21 CFR 886.5916)
Device Product Code:	HQD
PREDICATE DEVICE
	Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens(K162005).

DEVICE DESCRIPTION

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

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

. in the power range of -20.00 to +20.00 diopters for spheres
with base curves of 4.0 mm to 11.50 mm
with base curve chord of 6.0 mm to 6.5 mm ●
with diameters of 7.0 to 21.0 mm ●

The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material. The device herein described is substantially equivalent to the Acuity 100 (hexafocon A) Contact Lenses described in K162005.

INDICATIONS FOR USE

The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear.

PERFORMANCE DATA

Non-clinical Studies

Biocompatibility Testing

Biocompatibility evaluation was conducted on the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens in accordance to ISO 10993-1:2018 "Biological Evaluation of Medical Devices". The following tests were performed:

Cytotoxicity Agar Diffusion 1.
1. Systemic Toxicity
1. Ocular Irritation
Skin Sensitization 4.

Performance Testing

To establish the performance of Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses, the follow tests were performed:

1. Lens/solution compatibility
1. Manufacturing verification
1. Extractable testing
1. Contact angle
1. Dry shelf life
1. Lens stability testing

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

Comparison of Characteristics with the Predicate Device

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses manufactured by Acuity Polymers, Inc. have been found to show biocompatibility, for a surface device, limited contact. In addition to biocompatibility, the chemical, mechanical and optical characteristics of the new device have been shown to be substantially equivalent to the predicate device.

Lens Characteristics	NEW DEVICE	PREDICATE DEVICE
LensCharacteristics	Acuity 200™ (fluoroxyfocon A) Rigid GasPermeable Contact Lens	Acuity 100 (hexafocon A) Rigid Gas Permeable ContactLens K162005
Manufacturer	Acuity Polymers, Inc	Acuity Polymers, Inc
Material	fluoroxyfocon A	hexafocon A
Productionmethod	Lathe Cut	Lathe Cut
UV Blocking	Yes	Yes
Base Curves(varies with vault)	4.0 mm to 11.5 mm	4.0 mm to 11.5 mm
Base Curve Chord	6.0 mm to 6.5 mm	6.0 mm to 6.5 mm
Design	Standard geometry with anterior asphericsurface	Standard & reverse geometry with anterior asphericsurface
Diameters:	7.0-21.0 mm	7.0-21.0 mm
Power Range	-20.00D to +20.00D	-20.00D to +20.00D
Astigmatism rangecorrected	Up to 9.00 D	Up to 9.00 D
Add Powers (formultifocal)	+1.00 D to +4.00 D	+1.00 D to +4.00 D
Indicationsfor Use	The Acuity 200™ Rigid Gas PermeableContact Lenses are indicated for daily wearfor the correction of refractive error(myopia, hyperopia, presbyopia and/orastigmatism) in aphakic and non-aphakicpersons with non-diseased eyes. The lensmay be prescribed in spherical and asphericpowers ranging from -20.00 D to +20.00 Dfor daily wear.	The Acuity 100 (hexafocon A) Rigid Gas PermeableContact Lenses are indicated for daily wear for thecorrection of refractive error (myopia, hyperopia,presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may beprescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may beprescribed for daily wear in otherwise non-diseased eyesthat require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucidmarginal degeneration, or following penetratingkeratoplasty or refractive (e.g., LASIK) surgery.
Refractive Index	1.430	1.415
OxygenPermeability	200	111
Specific Gravity	1.18	1.27
Hardness (ShoreD)	78	80
Modulus (MPa)*	1194	1414
Tint	Visibility Tints - variousD&C Green #6, D&C Violet #2, SolventYellow 18, D&C Red #17	Visibility Tints - variousD&C Green #6, D&C Violet #2, D&C Yellow #18
Water Content	<1%	<1%

As measured at Acuity Polymers under described method.

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

Clinical Studies

Study Design

This study was an open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days. Seventy-four (74) subjects were enrolled in the study-of which 50 subjects wore the test lenses. Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and 24 subjects wore the control lenses (Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens). Subjects were evaluated at four independent clinical sites across the United States. Subjects wore the Test or Control lenses for 90 days bilaterally according to the randomization method.

Trial Objective

The objective of this study was to evaluate the safety and effectiveness of the Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.

Study Endpoints

Effectiveness Endpoints - The primary efficacy endpoint in this evaluation was a comparison of the contact lens corrected visual acuity results reported for the Test lenses versus the Control lenses. The working hypothesis was that the visual acuity results are substantially equivalent between the Test and the Control lenses.

Safety Endpoints - The primary safety endpoint in this evaluation was the comparison of the objective findings (slit lamp observations and lens fitting and deposit characteristics), subjective symptoms and adverse events reported as associated with the Test lenses with those findings reported as associated with the Control lenses. The working hypothesis was that the findings are substantially equivalent between the Test and the Control lenses

The total enrollment across all clinical sites was 74 subjects (148 eyes) with 50 subjects (100 eyes) in the test group and 24 subjects (48 eyes) in the control group. Of the 74 subjects enrolled. 58 subjects completed the scheduled visits (40 subjects in the test group and 18 subjects in the control group).

There were 55 females and 18 males in the study (3.1 ratio female/male). The average age of the subjects was 53.2 years (53.5 years in the test group and 52.7 years in the control group). Sixty-two and two tenths percent (62.2%) of the enrolled subjects were habitual rigid contact lens wearers, 25.7% were habitual soft contact lens wearers, and 10.8% were habitual spectacle lens wearers.

Clinical Study

Fifty-eight (58) of the 74 subjects enrolled completed the study. Of the 16 discontinued subjects, 9 subjects exited prior to lens dispensing. Ten subjects discontinued from the test arm (20%) and 6 subjects discontinued from the control arm (25%). In the test arm, the reasons for discontinuation included discomfort (cited by 4 subjects), lens handling (2 subjects), poor vision (1 subject), and lens positioning/fit (1 subject); the remaining

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

reasons cited were not directly related to the test lens (i.e. disinterest, lost to follow up, contracted shingles).

None of the completed or discontinued eyes in the test arm reported a severity of worse (>) than grade 2 for staining, edema, vascularization, hyperemia, infiltrates or any other complication. One (1) eye in the control arm reported a severity of grade 3 for bulbar redness. All other eyes treated with the control lens reported a severity of grade 2 or lower for other findings.

The test and control lenses performed similarly with respect to subject reported symptoms, problems and complaints. Symptoms reported with the highest frequency were discomfort (control 39%, test 38%), dryness (control 42%, test 31%), and irritation (control 31%, test 31%). These results indicate no clinical difference between the incidence of symptoms reported in the test arm compared to the control arm. The adverse events that occurred in the study were similar in both arms, in terms of incidence and severity.

The test and control lenses performed equally well with regards to vision safety measures-keratometry changes, refractive changes, and best corrected visual acuityover the 90-day treatment period. Trend analysis shows no emerging trends for test and control lenses for the duration of the study.

CONCLUSIONS

The non-clinical data demonstrates the safety of the device and demonstrates that the device should perform as intended. Clinical studies were completed and demonstrate that the Acuity 2001 Rigid Gas Permeable Contact Lens performs substantially equivalent to the predicate device currently marketed for the indication of correcting ametropia.

The clinical study results establish no clinically relevant differences between the Acuitv 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (predicate device) with respect to biomicroscopy findings, symptoms or vision safety measures; this clinical investigation supports the claim of substantial equivalence between the two device types with regard to clinical safety and effectiveness.

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.