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    K Number
    K072259
    Device Name
    OPHTHALMOSCOPE F-10
    Manufacturer
    NIDEK CO., LTD.
    Date Cleared
    2008-05-06

    (266 days)

    Product Code
    MYC
    Regulation Number
    886.1570
    Type
    Abbreviated
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K971671,K871268
    Why did this record match?
    Device Name :

    OPHTHALMOSCOPE F-10

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ophthalmoscope F-10 is intended for use in capturing images of the fundus which can be used for diagnosis of fundus diseases.

    Device Description

    The Ophthalmoscope F-10 is categorized as a Class 1 confocal laser scanning ophthalmoscope. The F-10 captures and records confocal images of the fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red and affords Indocyanine green (ICG) and fluorescein (FAG) angiography.

    AI/ML Overview

    The provided text does not contain specific acceptance criteria or a detailed study proving device performance in the way typically required for AI/ML-driven medical devices. This document is a 510(k) summary for an Ophthalmoscope, which is a hardware device for capturing images, not an algorithm for image analysis or diagnosis.

    Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, etc.) are not applicable to this type of device and submission.

    However, I can extract the information that is present:

    Acceptance Criteria and Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Functional specifications met"Nidek Company Ltd. has verified and validated that the Ophthalmoscope F-10 meets its functional specifications"
    Performance requirements met"Nidek Company Ltd. has verified and validated that the Ophthalmoscope F-10 meets its ... performance requirements"
    Compliance with applicable U.S. and international standards"complies with applicable U.S. and international standards (IFC 60601-1, 60601-1-1, 60601-1-2, 60825-1 and ISO 15004-2:2007) for products of its kind. This device complies with 21 CFR Parts 1010 and 1040, with the exception of those allowable performance deviations noted in FDA's Laser Notice 50."
    Substantial equivalence to predicate devices regarding safety and effectiveness and intended use"The Ophthalmoscope F-10 is substantially equivalent to the predicate devices... It is similar in characteristics, materials, features, has similar technological features, intended use and indications for use as the predicates, and do not raise any new questions of safety and effectiveness." (K971671: Heidelberg Retina Angiograph FA/ICGA (HRA/C) and K871268: Rodenstock Scanning Laser Ophthalmoscope)
    No new potential safety risks"Nidek Company Ltd., is of the opinion that the Ophthalmoscope F-10 docs not introduce any new potential safety risks"
    Effective and performs as well as other devices on the market"is as effective, and performs as well as devices currently on the market"

    Study Details (Based on the Provided Text)

    1. Sample size used for the test set and the data provenance: Not applicable. This device is a hardware ophthalmoscope, not an algorithm analyzing a dataset. The "performance" assessment focuses on engineering and safety standards.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI models is not relevant here.
    3. Adjudication method for the test set: Not applicable.
    4. 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 is not an AI/ML device providing assistance to readers.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a hardware device like an ophthalmoscope, "ground truth" would relate to its physical specifications and imaging capabilities (e.g., resolution, light output, image clarity). The document states it meets "functional specifications" and "performance requirements" but does not detail how these were measured or against what absolute "ground truth" they were compared other than compliance with engineering standards.
    7. The sample size for the training set: Not applicable. This device does not use a training set.
    8. How the ground truth for the training set was established: Not applicable.
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