The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy. The RxSight Contact Lens is used to maintain optical quality of the corneal surface and will provide lid stabilization to prevent blinking during therapeutic procedures that require magnification of the eye.

The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization.

The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.

AI/ML Overview

The provided document is a 510(k) summary for the RxSight Contact Lens, which seeks to establish substantial equivalence to a predicate device. It is not a study that proves the device meets specific acceptance criteria based on performance metrics that would typically be described with sensitivity, specificity, or similar statistical measures. Instead, the "acceptance criteria" here refer to conformance with regulatory requirements and equivalence to a predicate device, demonstrated through a comparison of physical characteristics and specific types of testing.

Therefore, many of the requested fields are not applicable because this is not a performance study in the traditional sense of evaluating an algorithm or diagnostic tool against a ground truth.

Here's the information that can be extracted and synthesized based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Product Code	HJK	HJK
Device Classification	21 CFR 886.1385	21 CFR 886.1385
Intended Use	Intended to aid in visualization and/or therapy in the anterior segment of the eye	Intended to aid in visualization and/or therapy in the anterior segment of the eye
Contact Material	PMMA	PMMA
Field of View	Wide angle	Wide angle
Image Magnification	1.40x (of predicate device)	1.30x
Laser Spot Magnification	0.710x (of predicate device)	0.766x
Contact Diameter	15.5 mm (of predicate device)	15.0 mm
Lens Height	16.5 mm	16.5 mm
How Supplied (Reusable/Single Use)	Single lens packaging, Non-sterile, Reusable	Single lens packaging, Non-sterile, Reusable
Biocompatibility	In accordance with ISO 10993-1, including: Cytotoxicity (per ISO10993-5), Sensitization (per ISO10993-10), and Ocular Irritation (per ISO10993-10)	Successfully performed and met acceptance criteria. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sterilization Validation	Recommended sterilization parameters achieve a Sterility Assurance Level of 10^-6, in accordance with ISO 10993-7	Performed to confirm criteria met. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Finished Product Performance Testing	General acceptance criteria for finished product performance (not explicitly detailed, but implied to be standard for this device type).	Met all acceptance criteria. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Substantial Equivalence to Predicate Device	Match or demonstrate equivalent safety and effectiveness to Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens (K872136) in terms of materials, technological characteristics, and principles of operation, with any minor variations not impacting safety or effectiveness.	The RxSight Contact Lens is substantially equivalent to the predicate device. It is manufactured from the same materials (PMMA), has the same technological characteristics (e.g., wide angle field of view, reusability), and principles of operation. Minor variations in specifications (Image Magnification, Laser Spot Magnification, Contact Diameter) do not impact safety or effectiveness. The descriptive characteristics of the RxSight Contact Lens are well-defined and adequate to ensure equivalence to the predicate device.

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

Sample Size for Test Set: Not applicable in the context of a clinical performance study with a "test set" for accuracy metrics like sensitivity/specificity. The testing performed was for biocompatibility, sterilization, and general finished product performance, not a diagnostic accuracy study. The document does not specify the number of individual devices or materials tested for these purposes.
Data Provenance: Not applicable. The testing described is laboratory-based (biocompatibility, sterilization, physical performance) rather than clinical data from human subjects from a specific country or collected retrospectively/prospectively.

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

Not applicable. "Ground truth" in the sense of expert-established diagnostic labels is not relevant for this type of device (a diagnostic contact lens) and the types of testing described (biocompatibility, sterilization, physical characteristics).

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication of diagnoses.

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 diagnostic contact lens, not an AI-powered diagnostic system. No MRMC study was conducted.

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

Not applicable. This device is a physical diagnostic contact lens, not an algorithm.

7. The Type of Ground Truth Used

Ground Truth: For biocompatibility and sterilization, the "ground truth" would be established by the relevant ISO standards (ISO 10993-1, ISO10993-5, ISO10993-10, ISO 10993-7) and their specified testing methodologies and acceptance limits. For physical characteristics and intended use, the "ground truth" is typically defined by engineering specifications and direct comparison to the predicate device's established characteristics. It is not an expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set in that context.

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

Not applicable. There is no training set.

Summary

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September 10, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

RxSight, Inc. Maureen O'Connell Vice President, Clinical/Regulatory Affairs 100 Colombia Aliso Viejo, California 92656

Re: K201909

Trade/Device Name: RxSight Contact Lens Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) Diagnostic Contact Lens Regulatory Class: Class II Product Code: HJK Dated: July 8, 2020 Received: July 9, 2020

Dear Maureen O'Connell:

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/cfpmp/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

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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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

Elvin Ng 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

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Indications for Use

510(k) Number (if known) K201909

Device Name RxSight Contact Lens

Indications for Use (Describe)

The RxSight Contact Lens is indication and treatment in the anterior segment of the eye.

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)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

APPLICANT:	RxSight, Inc.100 ColumbiaAliso Viejo, CA 92656
CONTACT PERSON:	Maureen O'ConnellVice President, Clinical and Regulatory Affairsmoconnell@rxsight.comTel: (978) 207-1245
DATE SUMMARY PREPARED:	September 4, 2020
TRADE NAME:	RxSight Contact Lens
COMMON NAME:	Diagnostic Contact Lens
CLASSIFICATION NAME:	Polymethylmethacrylate (PMMA) Diagnostic Contact Lens
DEVICE CLASSIFICATION:	Class II; 21 CFR 886.1385
PRODUCT CODE:	HJK
PREDICATE DEVICE:	Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens, K872136

DEVICE DESCRIPTION

The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization.

The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.

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INDICATIONS FOR USE

The RxSight Contact Lens is indicated for visualization and treatment in the anterior segment of the eye.

TECHNOLOGICAL CHARACTERISTICS COMPARISON

The technical features of the RxSight Contact Lens are as the features of the predicate device described in the table below. A comparison of the technological characteristics of the proposed and predicate devices is provided in the table below.

	Proposed DeviceRxSight Contact Lens	Ocular Instruments12.5 mm Peyman Wide Field YAGLaser Lens(K872136)
Product Code	HJK	HJK
Device Classification	21 CFR 886.1385	21 CFR 886.1385
Intended Use	Intended to aid in visualization and/ortherapy in the anterior segment of theeye	Intended to aid in visualization and/ortherapy in the anterior segment of theeye
Contact Material	PMMA	PMMA
Field of View	Wide angle	Wide Angle
Image Magnification	1.30x	1.40x
Laser Spot Magnification	0.766x	0.710x
Contact Diameter	15.0 mm	15.5 mm
Lens Height	16.5 mm	16.5 mm
How Supplied(Reusable/Single Use)	Single lens packaging,Non-sterile, Reusable	Single lens packaging,Non-sterile, Reusable.

SUMMARY OF PERFORMANCE TEST RESULTS

Performance standards for contact lenses have not been issued. The descriptive characteristics of the RxSight Contact Lens are well-defined and adequate to ensure equivalence to the predicate device.

The following tests were successfully performed with the device components to establish substantial equivalence of the RxSight Contact Lens to the predicate device:

Biocompatibility testing in accordance with ISO 10993-1 including ● Cytotoxicity (per ISO10993-5), Sensitization (per ISO10993-10), and Ocular Irritation (per ISO10993-10).
. Sterilization validation was performed to confirm that recommended sterilization parameters for this device achieved a Sterility Assurance Level of 10-6, in accordance with ISO 10993-7.
Finished product performance testing met all acceptance criteria. .

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The RxSight Contact Lens is substantially equivalent to the Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens cleared under K872136. These cleared devices are intended for use to enhance visualization and to aid in the treatment of the anterior segment of the eye. The predicate device is manufactured from the same materials, have the same technological characteristics and principles of operation as the RxSight Contact Lens. Any minor variation in specifications to the predicate devices do not impact safety or effectiveness of the lens during use.

Regulation Number and Section

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.