The LFR-260 is a portable manual refractor providing capabilities to the eyecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.

Device Description

The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions. The LFR-260 achieves the similar functionality as Comprehensive Phoropter, MDR-680, which is a standard refractor, but relies on the use of a micro lens array, a highdensity embedded display, and a tunable lens. The reduced number of lenses allows for higher portability and a smaller footprint.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LFR-260 device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Device Performance
Visual acuity chart or display with specified size, distance, and range of acceptable luminance based on the standard of ANSI Z80.21-2020.	"In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met." (This implies compliance with ANSI Z80.21-2020 for these characteristics.)
Lenses to measure refractive error.	"In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met." (This implies the lenses accurately measure refractive error.)
Jackson Cross Cylinder (JCC) unit.	"In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met." (This implies the JCC unit functions correctly.)
Inter-Pupillary Distance (IPD).	"In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met." (This implies the IPD measurement functions correctly.)
Ability to produce both double and quad view.	"Additionally, the system was evaluated to ensure it is able to produce both double and quad view and the ability of the cooling system to maintain the temperature of the tunable lenses. In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met." (This confirms the ability to produce double and quad view.)
Ability of the cooling system to maintain the temperature of the tunable lenses.	"Additionally, the system was evaluated to ensure it is able to produce both double and quad view and the ability of the cooling system to maintain the temperature of the tunable lenses. In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met." (This confirms the effective cooling system.)
Acceptance Criteria (Clinical Testing - Comparability to Predicate Device)	Reported Device Performance
Refractive measurements within 95% Limits of Agreement (LOA) for M, J0, and J45 compared to the predicate device.	For three subgroups (<=21, 22-40, and 40-60 years of age), measurements were within 95% LOA: -0.52D to 0.41D for M, -0.3D to +0.23D for J0, and -0.13D to +0.13D for J45. (This indicates the device meets the specified LOA.)
Acceptable repeatability and reproducibility for precision testing.	"Precision testing was also performed. All sub-tests indicated acceptable repeatability and reproducibility." (This confirms acceptable precision.)

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

Sample Size: The document does not explicitly state the total sample size used for the clinical test set. It only mentions that the Bland Altman analysis was performed "in three subgroups (<=21, 22-40 and 40-60 years of age)". Without further information, the exact number of participants is unknown.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

The document does not provide details on the number of experts used or their qualifications for establishing ground truth in the clinical study. It refers to "comparability of the device's refractive measurements to the predicate device," implying the predicate device's measurements served as the comparative standard. However, how the predicate device's measurements were obtained (e.g., by how many, and what type of experts) is not described.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's test set. The comparison is made against the predicate device's measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not reported. The study focused on the device's performance in comparison to a predicate device, not on the impact of AI assistance on human reader performance. The LFR-260 is described as a "portable digital refractor" used by an "eyecare provider" or "licensed eye care practitioner", suggesting it is a tool used by a human, rather than an AI meant to assist a human reader in interpretation.

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

Yes, a standalone performance evaluation of the device in comparison to the predicate device was conducted. The clinical testing specifically aimed to "demonstrate comparability of the device's refractive measurements to the predicate device," and reported the device's precision. This can be interpreted as a standalone performance evaluation of the LFR-260's measurement capabilities. The device's technological characteristics (micro lens array, tunable lenses, high pixel-density display, proprietary software) suggest it's generating the measurements, which are then compared.

7. Type of Ground Truth Used

The "ground truth" for the clinical study appears to be the refractive measurements obtained using the predicate device (Comprehensive Phoropter, MDR-680). The study aimed to demonstrate "comparability of the device's refractive measurements to the predicate device."

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. The LFR-260 is a physical device that performs measurements, not an AI/ML algorithm that requires a "training set" in the traditional sense of learning from data. While it contains "Proprietary Software," there's no indication it's a machine learning algorithm subject to training data.

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

As no training set is mentioned or implied for a machine learning algorithm, this question is not applicable based on the provided text.

Summary

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May 31, 2024

Image /page/0/Picture/1 description: The image shows 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.

Evolution Optiks Limited % John Smith Partner Hogan Lovells US LLP 555 13th Street NW Washington, District of Columbia 20004

Re: K233295

Trade/Device Name: LFR-260 Regulation Number: 21 CFR 886.1770 Regulation Name: Manual Refractor Regulatory Class: Class I Product Code: SBI Dated: May 3, 2024 Received: May 3, 2024

Dear John Smith:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Elvin Y. Ng -S

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

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Enclosure

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Indications for Use

510(k) Number (if known) K233295

Device Name LFR-260 System

Indications for Use (Describe)

The LFR-260 is a portable manual refractor providing capabilities to the evecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.

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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K233295

510(k) SUMMARY

Evolution Optiks LFR-260 System

Submitter

Evolution Optiks Limited

PASEA FINANCIAL CENTRE CORNER HARTS GAP & DAYRELLS ROAD CHRIST CHURCH BARBADOS BB14030

Phone: (203) 981 5489

Contact Person: Raul Mihali

Date Prepared: May 30, 2024

1. Device Information

Name of Device: LFR-260 System Common or Usual Name: Manual Refractor Classification Name: Manual Refractor

Regulation Number: 21 C.F.R. 886.1770

Product Code: SBI

Regulatory Class: Class I

2. Predicate Device Information

510(k) number K936205

Trade name: Comprehensive Phoropter, MDR-680

Classification Name: Manual Refractor

Regulation Number: 21 C.F.R. 886.1770

3. Device Description

The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions. The LFR-260 achieves the similar functionality as Comprehensive

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Phoropter, MDR-680, which is a standard refractor, but relies on the use of a micro lens array, a highdensity embedded display, and a tunable lens. The reduced number of lenses allows for higher portability and a smaller footprint.

The LFR-260 system is able to perform the same distance vision traditional refractive test with the standard optotypes (Snellen, ETDRS, Landolt C, pediatric optotypes) as a standard refractor, such as:

Determining the required spherical correction ●
. Determining the required astigmatic correction measuring with fan and block test and/or JCC (Jackson cross-cylinder)

The visual acuity tests will always be administered by an eye care practitioner licensed and registered by the appropriated body in the region intended to be used.

4. Intended Use / Indications for Use

5. Summary of Technological Characteristics

The intended use of LFR-260 is consistent with Comprehensive Phoropter, MDR-680, which is a manual refractor. The substantial equivalence table is provided below:

	LFR-260	Comprehensive Phoropter,MDR-680	Discussion
TechnologicalCharacteristics	The LFR-260 systemincludes a micro lens array,tunable lenses, and highpixel-density display toprovide the samefunctionality as atraditional reel of lenses toallow the measure ofrefractive error of the eye.	The ComprehensivePhoropter, MDR-680, is amanual refractor and isdefined as a device that isa set of lenses of variousdioptric powers intendedto measure the refractiveerror of the eye.	Differences intechnologicalcharacteristics donot raise differentquestions ofsafety andeffectiveness.Performance datademonstratescomparableperformance andsafety.
Overview of Device	The LFR-260 is a portablemanual refractor providingcapabilities to the eyecareprovider to performdistance vision testing andsubjectively measuresphere, cylinder and axisrefractive errors in patientsaged from 12-65 years oldwith healthy visual systems.	The ComprehensivePhoropter, MDR-680 isregulated under 886.1770,primary product code HKN.A manual refractor, whichis a device that is a set oflenses of various dioptricpowers intended tomeasure the refractiveerror of the eye.	Both devices areintended tomeasurerefractive error ofthe eye.
Operation/TestsAvailable	The LFR-260 deviceprovides similar subjective	As a manual refractor, thecomprehensive phoropter	Substantiallysimilar. Both
	refraction as manualrefractors including sphere,cylinder, and axismeasurements.The LFR-260 can be usedto administer comparableeye examination that isstandard of care in eye careprofessionals' clinics.Specifically, the LFR-260 isable to perform comparabletraditional refractive testswith the standard optotypes(e.g., Snellen, ETDRS,Landolt C, pediatricoptotypes) such as:• Determining the requiredspherical correction• Determining the requiredastigmatic correctionmeasuring with fan andblock test and/or JCC(Jackson cross-cylinder)	MDR-680 providessubjective refractionincluding sphere, cylinderand axis measurements. Itcan be used to administerthe eye examination that isstandard in eye careprofessionals' clinics.Manual refractors canperform traditionalrefractive tests such as:• Determining the requiredspherical correction• Determining the requiredastigmatic correctionmeasuring	systems provideexaminations tomeasurerefractive error ofthe eye. The LFR-260, however isindicated fordistance visiontesting only.
Type of Display	High pixel-density display	Traditional screen is usedto display eye charts	A high pixel-density display isused to view theeye charts withthe subject devicewhile a traditionalscreen is usedwith manualrefractors.Though there aretechnologicaldifferences, bothdisplays provideusers with eyecharts for useduring a routineeye examination.There are no newquestions ofsafety oreffectiveness dueto this difference.
Type of Lenses	Tunable Lenses	Traditional reel of lenses	Both types oflenses enable thedevices toperformsubjectiverefractive tests.There are no newquestions ofsafety oreffectiveness dueto this difference.
Included Software	Proprietary Software usedto control the LFR-260system by an ECP	No software required	The softwarecontrols the LFR-260 to achieve itsintended use.There are no newquestions ofsafety oreffectiveness.
Use Environment	Professional HealthcareFacilityEnvironment/OptometricClinics,Home HealthcareEnvironment	Professional HealthcareFacilityEnvironment/OptometricClinics	Differences in useenvironment donot impact theintended use ofthe device.There are no newquestions ofsafety oreffectiveness.Performance datademonstratescomparableperformance andsafety.
Intended User	Licensed eye carepractitioner	Licensed eye carepractitioner	Same

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6. Performance Data

Both bench and clinical testing were performed to demonstrate that LFR-260 performs safely and effectively in achieving its intended use.

The LFR-260 underwent bench testing to evaluate the following characteristics:

Visual acuity chart or display with specified size, distance, and range of acceptable luminance ● based on the standard of ANSI Z80.21-2020.
Lenses to measure refractive error. .
Jackson Cross Cylinder (JCC) unit. ●
Inter-Pupillary Distance (IPD). ●

Additionally, the system was evaluated to ensure it is able to produce both double and quad view and the ability of the cooling system to maintain the temperature of the tunable lenses.

In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met.

The company also performed clinical testing to demonstrate comparability of the device's refractive measurements to the predicate device.

Based on Bland Altman analysis, in three subgroups (<=21, 22-40 and 40-60 years of age), the measurements were within 95% Limits of Agreement (LOA), defined as 0.75D for M and 0.5D for J0 and J45 (-0.52D to 0.41D for M, -0.3 to +0.23 for J0 and -0.13 to +0.13 for J45).

Precision testing was also performed. All sub-tests indicated acceptable repeatability and reproducibility.

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Based on the clinical performance as documented in the pivotal clinical study, the LFR-260 has a safety and effectiveness profile that is similar to Comprehensive Phoropter, MDR-680.

7. Conclusions

The LFR-260 system and a manual refractor have the similar intended use, performs the similar examinations, and provides the same output. Both systems are used by a licensed eye care practitioner. The outputs of the LFR-260 are the same as a traditional refraction exam performed using a manual refractor. Even though there are technological differences do not raise different questions of safety and effectiveness as demonstrated through bench and clinical testing. Thus, the LFR-260 is substantially equivalent to Comprehensive Phoropter, MDR-680.

Regulation Number and Section

§ 886.1770 Manual refractor.

Link to an amendment published at 90 FR 55991, Dec. 4, 2025. (a)
Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.