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510(k) Data Aggregation

    K Number
    K233295

    Validate with FDA (Live)

    Device Name
    LFR-260
    Manufacturer
    Evolution Optiks Limited
    Date Cleared
    2024-05-31

    (245 days)

    Product Code
    SBI
    Regulation Number
    886.1770
    Type
    Traditional
    Panel
    Ophthalmic
    Age Range
    All
    Reference & Predicate Devices
    K936205
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.
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