The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.

Device Description

The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "RxSight Insertion Device." It outlines the device's characteristics, intended use, and demonstrates substantial equivalence to a previously cleared predicate device.

Let's break down the information relevant to acceptance criteria and study proof for this specific device.

Analysis of the Provided Text:

The provided text describes a medical device, the "RxSight Insertion Device," which is an Intraocular Lens (IOL) injector. The FDA document clears this device based on its substantial equivalence to a predicate device.

However, the nature of this particular device (an IOL insertion tool) and the detailed information provided in the 510(k) summary do not involve the kind of AI-driven diagnostic or image analysis performance that would typically have acceptance criteria presented as sensitivity, specificity, or AUC, nor "ground truth" derived from expert consensus on images.

Instead, the "performance" here relates to the mechanical function of the device and its biological safety (e.g., impact on endothelial cell density).

Therefore, I cannot directly fill in a table for AI performance metrics like sensitivity, specificity, etc., or answer questions about multi-reader multi-case studies, training sets, or expert adjudicated ground truth in the way one would for an AI diagnostic algorithm.

Based on the provided text, here’s how we can infer relevant "acceptance criteria" for this mechanical device and the study proving it meets them:

1. Acceptance Criteria and Reported Device Performance (Inferred):

Since this is a mechanical insertion device, the acceptance criteria are not in terms of diagnostic accuracy, but rather in terms of its ability to safely and effectively deliver an IOL without causing significant harm to the eye.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Mechanical Performance: IOL integrity post-injection (dimensions, sagitta)	Met: "Mechanical dimensions and sagitta were verified following lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012." This implies that the IOL maintained its intended shape and optical properties after being folded and injected by the device.
Optical Properties: IOL surface and bulk homogeneity post-injection	Met: "Optical properties including overall surface and bulk homogeneity were tested pre- and post-lens injection per ISO 11979-2:2014." This suggests the insertion process did not adversely affect the optical quality of the IOL.
Coating Stability: Durability of the cartridge coating over shelf-life	Met: "Additionally, a particulate analysis was performed on aged product to demonstrate coating stability of the sterile insertion device coating following shelf-life aging." This indicates the coating remains intact and does not shed harmful particulates throughout its shelf life, which is crucial for preventing complications during surgery.
Clinical Safety: Non-inferiority in post-operative Endothelial Cell Density (ECD) loss compared to predicate/control IOL insertion devices.	Met: "The analysis presented in the 510(k) shows similar rates of ECD loss in eyes implanted with either device, supporting the safety of insertion of the LAL with the RxSight Insertion device." This is a key safety measure, demonstrating the device does not cause excessive damage to the cornea's endothelial cells during insertion, a vital aspect of maintaining corneal clarity. The predicate device's performance implicitly serves as an "acceptance criterion" benchmark for safety.

2. Sample Size and Data Provenance (for clinical safety study):

Sample Size: The document states "post-operative endothelial cell density (ECD) data was collected in a prospective clinical study." It doesn't specify the exact number of patients or eyes.
Data Provenance: "prospective clinical study." No country of origin is specified, but typically for FDA submissions, studies are conducted in a way that aligns with US clinical study requirements (e.g., IRB approval).

3. Number of Experts and Qualifications for Ground Truth:

Not applicable in the typical sense of AI ground truth. For this device, "ground truth" for the mechanical tests would be derived from precisely measured physical properties (e.g., using calipers, optical instruments) and analytical chemistry tests (e.g., particulate analysis).
For the clinical safety study (ECD), the "ground truth" is measured physiological data (endothelial cell count and density) obtained via clinical instruments, not subjective expert assessment of images.

4. Adjudication Method for the Test Set:

Not applicable in the typical AI sense. For mechanical tests, the results are objective measurements. For the ECD clinical study, the outcome is quantitative physiological data, not requiring multiple human adjudicators for "ground truth."

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

No, not specified or relevant for this type of device. MRMC studies are typically for diagnostic imaging AI tools comparing human reader performance with and without AI assistance. This device is a surgical insertion tool, not a diagnostic aid.

6. Standalone (Algorithm only) Performance:

Not applicable. This device is a mechanical tool. There is no "algorithm only" performance separate from its mechanical function.

7. Type of Ground Truth Used:

Quantitative Measurements and Clinical Outcomes: For mechanical aspects, the ground truth was based on:
- Precise measurements of IOL dimensions and sagitta before and after insertion (ISO 11979-3:2012).
- Evaluation of optical properties (ISO 11979-2:2014).
- Particulate analysis.
For clinical safety, the "ground truth" was endothelial cell density (ECD) measurements, which are objective physiological data.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set for model development. The mechanical tests and clinical safety study are for device validation, not for training a model.

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

Not applicable. As above, no training set for an AI model.

Summary

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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.

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

Re: K192926

Trade/Device Name: RxSight Insertion Device Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserved Product Code: MSS Dated: December 21, 2019 Received: December 23, 2019

Dear Ms. 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/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

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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 (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-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,

for Tieuvi Nguyen, Ph.D. 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) K192926

Device Name RxSight Insertion Device

Indications for Use (Describe)

The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.

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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1.0 510(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 SUMMARYPREPARED:	January 10, 2020
TRADE NAME:	RxSight Insertion Device
COMMON NAME:	IOL Injector
CLASSIFICATION NAME:	Folders and Injectors, Intraocular Lens (IOL)
DEVICE CLASSIFICATION:	Class I; 21 CFR 886.4300
PRODUCT CODE:	MSS
PREDICATE DEVICE:	RxSight Insertion Device. K181401

1.1 DEVICE DESCRIPTION

1.2 INDICATIONS FOR USE

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1.3 TECHNOLOGICAL CHARACTERISTICS COMPARISON

The technical features of the RxSight Insertion Device, both predicate and proposed, are the same as no modifications to these features are proposed in this 510(k) Premarket Notification. A comparison of the technological characteristics of the proposed and predicate devices is provided in the table below.

	RxSight Insertion DeviceProposed Device	RxSight Insertion DevicePredicate Device(K181401)
Product Code	MSS	MSS
Indications for Use	The RxSight Insertion Device is indicatedfor the folding and insertion of a 3-piecesilicone, intraocular lens into the human eyethrough a surgical incision. The RxSightInsertion Device is intended for theinsertion of the RxSight Light AdjustableLens, the Bausch & Lomb LI61A0 IOL andIOL models validated for use with thisdevice in IOL approved labeling.	The RxSight Insertion Device is indicatedfor the folding and insertion of a 3-piecesilicone, intraocular lens into the humaneye through a surgical incision. TheRxSight Insertion Device is only for theinsertion of the Bausch & Lomb LI61A0IOL and IOL models validated for use withthis device in IOL approved labeling
Operating Principle	An IOL is placed in a loading cartridge.Cartridge snapped into the handpiece.Screw plunger advances the IOL throughthe cartridge which folds the IOL andadvances it into the eye.	An IOL is placed in a loading cartridge.Cartridge snapped into the handpiece.Screw plunger advances the IOL throughthe cartridge which folds the IOL andadvances it into the eye.
Pre-loaded IOL	No	No
Material (Injector)	Titanium	Titanium
Material (cartridge)	Polypropylene	Polypropylene
Cartridge Coating	LubriMATRIX™	LubriMATRIX™
How Supplied(Reusable/Single Use)	Handpiece - ReusableCartridge - Single Use, supplied sterile	Handpiece - ReusableCartridge - Single Use, supplied sterile
Method ofSterilization	Handpiece - AutoclaveCartridge - Ethylene Oxide to SAL 10-6	Handpiece - AutoclaveCartridge - Ethylene Oxide to SAL 10-6

1.4 SUMMARY OF PERFORMANCE TEST RESULTS

The descriptive characteristics are well-defined and adequate to ensure equivalence of the RxSight Insertion Device with the predicate device.

Non-clinical performance testing included simulated surgical manipulation and recovery of properties including both pre- and post-injection evaluation of aged IOLs in accordance with ISO 11979-3:2012 in support of the proposed 1 year shelf-life. Specifically, mechanical dimensions and sagitta were verified following lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Optical properties including overall surface and bulk homogeneity were tested pre- and post-lens injection per ISO 11979-2:2014.

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Additionally, a particulate analysis was performed on aged product to demonstrate coating stability of the sterile insertion device coating following shelf-life aging.

Endothelial Cell Density Clinical Data

To evaluate whether the RxSight insertion device (with associated insertion methods) presents a significant risk to the corneal endothelium, post-operative endothelial cell density (ECD) data was collected in a prospective clinical study. This study compared the ECD changes following cataract surgery between eyes implanted with the RxLAL using the RxSight insertion device and eyes implanted with a commercially available monofocal control IOL and associated insertion device. The analysis presented in the 510(k) shows similar rates of ECD loss in eyes implanted with either device, supporting the safety of insertion of the LAL with the RxSight Insertion device.

Conclusion

The RxSight Insertion Device has the same intended use as the legally marketed predicate devices identified in this 510(k) premarket notification and other IOL injectors regulated under 21 CFR 886.4300. This device continues to meet all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device. Performance data support the conclusion that the proposed RxSight Insertion Device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 886.4300 Intraocular lens guide.

(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.