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510(k) Data Aggregation

    K Number
    K031564
    Device Name
    CSS
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Date Cleared
    2003-10-07

    (141 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K011202,K991960
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.

    Device Description

    The CSS is an accessory device that is intended to be used in conjunction with currently marketed automated debrider systems and ESU's the same as the current MSI Bipolar Sheath. The CSS is designed to fit directly over various sizes of straight automated debrider system blades. The CSS will be available in a variety of diameters and in lengths. When the CSS is inserted over one of the debrider blades, the device may be used to cauterize tissue. The CSS can be utilized to provide spot coagulation or to coagulate tissue while the debrider blade is in operation.

    AI/ML Overview

    The provided text describes a 510(k) summary for the "CSS" (Coagulation Device) a modification to the MSI Bipolar Sheath. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in the provided text.

    Here's a breakdown of what can be extracted and what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence in design, materials, construction, and intended use as predicate devices.The CSS is stated to be "substantially equivalent in design, materials, construction and intended use" to the predicate devices (MSI Bipolar Sheath, K011202; Stryker Serfac K991960).
    Does not raise new safety and efficacy concerns compared to similar legally marketed devices.The document explicitly states, "the CSS does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices."
    Functionality and conformance to design input requirements."Bench testing was conducted to determine device functionality and conformance to design input requirements." (No specific criteria or results are provided, only that testing was conducted.)
    Differences in power are substantiated through applicable performance testing."The differences in power have been substantiated through applicable performance testing." (No specific criteria or results are provided.)

    Missing Information:

    • Specific quantitative or qualitative acceptance criteria beyond "substantially equivalent" and "no new safety/efficacy concerns."
    • Detailed performance metrics (e.g., coagulation time, tissue effect, safety margins for specific power differences).
    • Actual data demonstrating how the device met these criteria.

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: Not specified. The document only mentions "Bench testing."
    • Data Provenance: Not specified. It's bench testing, so likely conducted in a lab setting, but no country of origin is mentioned. The testing is retrospective, as it's for verification of a device.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    • Not applicable. The study involved bench testing, not human interpretation or clinical data requiring expert ground truth establishment in the traditional sense.

    4. Adjudication Method for the Test Set:

    • Not applicable. As this was bench testing, there's no mention of an adjudication method among experts.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

    • No, an MRMC study was not done. This device is an accessory for surgical procedures, and the testing described is bench testing, not a clinical study involving human readers interpreting cases.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Yes, in a way. The "bench testing" can be considered a standalone performance evaluation of the device itself (not an algorithm), without human-in-the-loop performance influencing the device's basic functionality. However, it's not "algorithm only" as there's no explicit algorithm described.

    7. The Type of Ground Truth Used:

    • For the bench testing, the "ground truth" would be engineering specifications and design input requirements for functionality, materials, and power characteristics. This is based on engineering/design specifications for the device.

    8. The Sample Size for the Training Set:

    • Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical device.

    9. How the Ground Truth for the Training Set was Established:

    • Not applicable, as no training set is mentioned.

    In summary, the provided document describes a 510(k) submission for a medical device accessory (CSS) that relies on demonstrating substantial equivalence through bench testing to established predicate devices. It does not provide the detailed study design, specific acceptance criteria, or quantitative results typical of studies for novel devices or AI/software as a medical device (SaMD).

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