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510(k) Data Aggregation

    K Number
    K021585
    Device Name
    STELLAR SERIES SURGICAL LIGHTS WITH HERMES
    Manufacturer
    SKYTRON, DIV. THE KMW GROUP, INC.
    Date Cleared
    2002-11-13

    (183 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STELLAR SERIES SURGICAL LIGHTS WITH HERMES

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

    The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC).

    A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.

    Device Description

    Stellar Series Surgical Lights with Hermes

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a surgical lamp device (Skytron Stellar Series Surgical Lights with Hermes). This type of document is a regulatory approval and does not contain the detailed technical study information outlined in your request.

    The letter confirms substantial equivalence to a predicate device, allowing the manufacturer to market the product. However, it does not include:

    1. A table of acceptance criteria and reported device performance: This document does not detail specific performance metrics or acceptance criteria for the surgical lights.
    2. Sample size for the test set or data provenance: There is no mention of a test set, sample sizes, or where data originated.
    3. Number/qualifications of experts for ground truth: Ground truth determination is not discussed as there's no mention of a study involving expert assessment.
    4. Adjudication method: Not applicable as no expert-based ground truth is discussed.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: This is not pertinent to a surgical lamp and is not mentioned. AI assistance is also not relevant to this device.
    6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device (surgical light), not an algorithm.
    7. Type of ground truth used: Not applicable as there's no data analysis discussed in this letter.
    8. Sample size for the training set: Not applicable as no algorithm training is discussed.
    9. How ground truth for the training set was established: Not applicable.

    In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence of a physical medical device. It does not contain the detailed study design, performance data, or AI-related metrics that your request is asking for.

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