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510(k) Data Aggregation

    K Number
    K233295
    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
    Reference & Predicate Devices
    K936205
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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 (
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