Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The Acuity™ 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

Acuity 200™ with Tangible® Hydra PEG® (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. Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.

Acuity 200™ with Tangible® Hydra PEG® (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

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, based on substantial equivalence to predicate devices, rather than a direct study validating specific acceptance criteria against reported performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in the provided text in the format you requested, as the submission relies on demonstrating similarity to already approved devices.

However, I can extract information related to the performance data mentioned and the basis for determining substantial equivalence.

Here's an analysis based on the provided text, addressing your points as much as possible:

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

The document states that the new device has been shown to be "substantially equivalent" to predicate devices. This implies that the acceptance criteria are met if the new device's performance is comparable to the predicate devices across various characteristics. The "Comparison of Characteristics with the Predicate Device" table serves as the primary evidence for this.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Acuity 200™ with Tangible® Hydra PEG®)
Material	fluoroxyfocon A (matching predicate K201194, K203571)	fluoroxyfocon A
Production Method	Lathe Cut (matching predicate devices)	Lathe Cut
UV Blocking	Yes (matching predicate devices)	Yes
Base Curves	4.0 mm to 11.5 mm (matching predicate K201194, K203571, within range of K161100)	4.0 mm to 11.5 mm
Base Curve Chord	6.0 mm to 6.5 mm (matching predicate devices)	6.0 mm to 6.5 mm
Design	Standard geometry with anterior aspheric surface (matching predicate K201194, K203571)	Standard geometry with anterior aspheric surface
Diameters	7.0-21.0 mm (matching predicate K201194, K203571, within range of K161100)	7.0-21.0 mm
Power Range	-20.00D to +20.00D (matching predicate devices)	-20.00D to +20.00D
Astigmatism Range	Up to 9.00 D (matching predicate K201194, K203571, comparable to K161100's up to 10.00 D)	Up to 9.00 D
Add Powers	+1.00 D to +4.00 D (matching predicate devices)	+1.00 D to +4.00 D
Indications for Use	Must be for daily wear for correction of refractive error (myopia, hyperopia, presbyopia, astigmatism) in aphakic and non-aphakic persons with non-diseased eyes, and for management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-keratoplasty/LASIK surgery). Must also be compatible with chemical disinfection. (Matching and expanding on predicates)	Matches and expands on previous predicates.
Refractive Index	1.430 (matching predicate K201194, K203571, comparable to K161100's 1.4406)	1.430
Oxygen Permeability	200 (matching predicate K201194, K203571, superior to K161100's 65)	200
Specific Gravity	1.18 (matching predicate K201194, K203571, comparable to K161100's 1.27)	1.18
Hardness (Shore D)	78 (matching predicate K201194, K203571)	78
Modulus (MPa)	1194 (matching predicate K201194, K203571)	1194
Tint	Visibility Tints (various as specified) (matching predicate devices)	Visibility Tints (various as specified)
Water Content	<1% (matching predicate devices)	<1%
Lens Type	RGP (matching predicate devices)	RGP
Biocompatibility	Must meet ISO 10993-1:2018 standards (Cytotoxicity, Systemic Toxicity, Ocular Irritation)	Evaluation conducted; found to show biocompatibility for a surface device, limited contact.
Performance Testing	Must demonstrate Lens/solution compatibility, Manufacturing verification, Contact angle Measurement, Accelerated Wet Shelf-Life testing, Lens stability testing.	Tests performed; characteristics shown to be substantially equivalent.

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

Sample Size: The document does not specify a "test set" sample size in terms of patient data for clinical evaluation of the current device. The clearance is based on non-clinical data and substantial equivalence.
Data Provenance: Not applicable in the context of clinical testing of this specific device for its performance against clinical acceptance criteria. The data presented is primarily non-clinical (biocompatibility, material testing, performance testing) to demonstrate substantial equivalence to previously cleared devices.

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

This information is not provided. The clearance is based on non-clinical testing and comparison to predicate devices, not on a clinical study requiring expert ground truth establishment for a test set.

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

Not applicable, as no clinical test set requiring adjudication is described for this specific device.

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 device is a contact lens, not an AI-assisted diagnostic tool, so an MRMC study is outside its scope.

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

Not applicable, as this is a medical device (contact lens), not a standalone algorithm.

7. The type of ground truth used:

For the non-clinical tests (biocompatibility, performance testing), the "ground truth" would be established by validated laboratory testing methods and industry standards (e.g., ISO 10993-1:2018).
For the overall device, the "ground truth" for its safety and effectiveness is primarily established by its substantial equivalence to predicate devices that have prior clearance based on their own safety and effectiveness data (which would include clinical studies for those predicate devices as referenced).

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.

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

Not applicable.

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 30, 2021

Acuity Polymers, Inc. James A. Bonafini, Jr. President & COO 1667 Lake Ave. Suite 303 Rochester, NY 14615

Re: K213538

Trade/Device Name: Acuity 200™ Tangible® Hydra PEG® (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: November 5, 2021 Received: November 8, 2021

Dear James Bonafini:

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.

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

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

801); medical device 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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K213538

Device Name

Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Indications for Use (Describe)

The Acuity™ 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

The assigned 510(k) number is K213538

SUBMITTER

Date Prepared:	November 5, 2021
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
DEVICE
	Common Name: Daily Wear Contact Lens
Proprietary Name:	Acuity 200™ with Tangible® Hydra PEG® (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 DEVICES
	Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens(K201194)
	Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens(K203571)
	Optimum GP with HPT (roflufocon C, D, and E Daily Wear ContactLenses (K161100)

DEVICE DESCRIPTION

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

properties while not affecting the mechanical or optical properties of the underlying material.

Acuity 200™ with Tangible® Hydra PEG® (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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K201194), Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K203571) and the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (K161100)

INDICATIONS FOR USE

Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The Acuity™ 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

PERFORMANCE DATA

Non-clinical Studies

Biocompatibility Testing

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

1. Cytotoxicity - Agar Diffusion
1. Systemic Toxicity
1. Ocular Irritation

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

Performance Testing

To establish the performance of Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, the follow tests were performed:

1. Lens/solution compatibility
1. Manufacturing verification
1. Contact angle Measurement
1. Accelerated Wet Shelf-Life testing
1. Lens stability testing

Comparison of Characteristics with the Predicate Device

Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens 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 devices.

	NEW DEVICE	PREDICATE DEVICEK201194, K203571	PREDICATE DEVICE
LensCharacteristics	Acuity 200™ withTangible® Hydra PEG®(fluoroxyfocon A) Rigid GasPermeable Contact Lens	Acuity 200™ (fluoroxyfoconA) Rigid Gas PermeableContact Lens	Optimum GP with HPT(roflufocon C, D, and E DailyWear Contact Lenses (K161100)
Manufacturer	Acuity Polymers, Inc	Acuity Polymers, Inc	Contamac Ltd.
Material	fluoroxyfocon A	fluoroxyfocon A	roflufocn C, D, E
Productionmethod	Lathe Cut	Lathe Cut	Lathe Cut
UV Blocking	Yes	Yes	Yes
Base Curves(varies withvault)	4.0 mm to 11.5 mm	4.0 mm to 11.5 mm	5.0 mm to 8.0 mm
Base CurveChord	6.0 mm to 6.5 mm	6.0 mm to 6.5 mm	6.0 mm to 6.5 mm
Design	Standard geometry with anterioraspheric surface	Standard geometry with anterioraspheric surface	Standard & reverse geometry withanterior aspheric surface
Diameters:	7.0-21.0 mm	7.0-21.0 mm	7.0-22.0 mm
Power Range	-20.00D to +20.00D	-20.00D to +20.00D	-20.00D to +20.00D
Astigmatismrange corrected	Up to 9.00 D	Up to 9.00 D	up to 10.00 D
Add Powers (formultifocal)	+1.00 D to +4.00 D	+1.00 D to +4.00 D	up to +4.00 D
Indicationsfor Use	The Acuity 200™ withTangible® Hydra PEG®(fluoroxyfocon A) Rigid GasPermeable Contact Lens isindicated for daily wearfor the correction of refractiveerror (myopia, hyperopia,presbyopia and/or astigmatism) in	The Acuity 200™ (fluoroxyfoconA) Rigid Gas Permeable ContactLens is indicated for daily wearfor the correction of refractiveerror (myopia, hyperopia,presbyopia and/or astigmatism) inaphakic and non-aphakic personswith non-diseased eyes. The lenses	Indicated for the daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia and/or presbyopia. The lensmay also be prescribed for themanagement or irregular corneal

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

	aphakic and non-aphakic personswith non-diseased eyes. Thelenses may be prescribed for dailywear in otherwise non-diseasedeyes that require a rigid contactlens for the management ofirregular corneal conditions suchas keratoconus, pellucid marginaldegeneration, or followingpenetrating keratoplasty orrefractive (e.g., LASIK) surgery.The Acuity™ 200 with Tangible®Hydra-PEG® (fluoroxyfocon A)Rigid Gas Permeable Contact Lensmay be cleaned and disinfectedusing a chemical (not heat) lens caresystem.	may be prescribed for daily wearin otherwise non-diseased eyesthat require a rigid contact lens forthe management of irregularcorneal conditions such askeratoconus, pellucid marginaldegeneration, or followingpenetrating keratoplasty orrefractive (e.g., LASIK) surgery.	conditions such as keratoconus andpost graft fitting.
Refractive Index	1.430	1.430	1.4406 (roflufocon C)
OxygenPermeability	200	200	65
Specific Gravity	1.18	1.18	1.27
Hardness (ShoreD)	78	78	NA
Modulus (MPa)	1194	1194	NA
Tint	Visibility Tints - variousD&C Green #6, D&C Violet #2,Solvent Yellow 18, D&C Red#17	Visibility Tints - variousD&C Green #6, D&C Violet #2,Solvent Yellow 18, D&C Red #17	Visibility Tints - variousD&C Green #6, D&C Red #17,Solvent Yellow #18
Water Content	<1%	<1%	<1%
Lens Type	RGP	RGP	RGP

Clinical Studies

No clinical studies were deemed necessary for the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens as Acuity 200™ fluoroxyfocon A was cleared via K201194 where clinical studies were described. Expanded indications for irregular corneas were described in K203571.

CONCLUSIONS

The non-clinical data demonstrates the safety of the device and that the device should perform as intended. The Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens performs substantially equivalent to the predicate devices currently marketed for the indication of correcting ametropia.

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.