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    K Number
    K963919
    Device Name
    LSI VIDEOSCOPIC DISPLAY SYSTEM
    Manufacturer
    LSI SOLUTIONS
    Date Cleared
    1997-01-08

    (100 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LSI Videoscopic Display System produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy.

    Device Description

    The LSI Videoscopic Display System utilizes advanced video projection technology to display an image on a sterile, disposable screen appropriately positioned within the surgical field.

    AI/ML Overview

    This submission, K963919, describes a display system rather than an AI device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML medical devices, is not directly applicable or available in the provided text.

    The information primarily focuses on comparing the technical specifications of the LSI Videoscopic Display System to a predicate conventional video monitor.

    However, I can extract the relevant comparative information as presented in the document, which serves as the "acceptance criteria" through a demonstration of substantial equivalence to the predicate device in terms of technical performance.

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the LSI Videoscopic Display System are implicitly defined by its substantial equivalence to the Sony Color Video Monitor (PVM-1343MD) across various technical specifications. The "study" for this type of device typically involves a direct comparison of these specifications to demonstrate that the new device performs at least as well as, or better than, the predicate.

    SpecificationAcceptance Criteria (Predicate Device: Sony PVM-1343MD)Reported Device Performance (LSI Videoscopic Display System Model 001)
    Indications For UseProduces high quality video images for use in a wide range of medical applications, including surgery, microscopy, endoscopy and A/V.Produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy.
    Diagonal Picture Measure (in.)1314 (Slightly larger - meets or exceeds)
    Resolution>600 (H) TV lines (2000 Characters (50 characters/line x 25 lines))800 (H) x 600 (V) active pixels (Higher resolution - meets or exceeds)
    Video Input1.0V p-p, 75 ohms1.0V p-p, 75 ohms (Matches)
    Audio InputPhono jackPhono jack (Matches)
    Power Requirements110-130 V AC at 50-60 Hz120V AC at 60 Hz, 230V AC at 50 Hz (Compatible with common regional power variations, encompassing predicate)
    Power Consumption99W (approx.)600 W (approx.) (Higher power consumption, but this is a technical characteristic, not necessarily a performance deficit for a display system)
    Dimensions (in.)13.5 (H) x 13.63 (W) x 16.25 (D)8.04 (H) x 12.2 (W) x 16.38 (D) (Different dimensions, but within reasonable variations for a medical device with similar function)
    Weight (lb.)36.428.5 (Lighter - meets or exceeds)
    Sterile DisposablesNonePlastic screen for placement in the surgical field. (Additional feature, not a direct comparison point for equivalence in standard functionality, but enhances clinical utility)
    Image SourceSMPTE C (American standard phosphor)Texas Instruments Digital Micromirror Projector (Different technology, but the output resolution and image quality are the primary comparison points for equivalence)

    Additional Information Not Applicable to this Device Type (AI/ML Specifics):

    Due to the nature of K963919 as a conventional medical device (a display system) and not an AI/ML device, the following points are not relevant or cannot be extracted from the provided text:

    1. Sample size used for the test set and the data provenance: Not applicable. Performance is based on technical specifications.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance is based on technical specifications.
    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-assisted device.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be the measured physical and electrical characteristics of the device.
    7. The sample size for the training set: Not applicable. This device does not use a training set as it's not an AI/ML model.
    8. How the ground truth for the training set was established: Not applicable.
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