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510(k) Data Aggregation

    K Number
    K012979
    Device Name
    COMPRESSIBLE LIMB SLEEVE
    Manufacturer
    MEDICAL DEVICE SERVICES, INC.
    Date Cleared
    2002-05-08

    (245 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K942664
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE SERVICES, INC.

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

    The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.

    Device Description

    The compressible sleeve is a garment used for compressing patient's lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a reprocessed compressible limb sleeve. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often seen for novel devices or software.

    Here's an analysis based on the provided information, addressing your points where possible:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceComments
    Functional and Safety CharacteristicsNo significant difference in functional and safety characteristics between new and reprocessed devices.Data indicates no significant difference in functional and safety characteristics between new and reprocessed devices.This is the overarching acceptance criteria for demonstrating substantial equivalence. Specific metrics for "functional and safety characteristics" are not detailed in this summary.
    Technological CharacteristicsSubstantially equivalent in materials, design, and intended use to the sleeves as originally distributed.The reprocessed sleeves are substantially equivalent (in materials, design, and intended use) to the sleeves as originally distributed.This is a declaration of equivalence rather than a specific performance metric.

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

    • Test Set Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," which implies a sample was used, but the size of this sample is not provided.
    • Data Provenance: The study was "conducted at Medical Device Services, Inc." It appears to be a bench test conducted by the manufacturer, rather than a clinical study with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the way they would be for patient-centric studies.

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

    • Not Applicable. This submission describes bench testing for a physical medical device (a reprocessed limb sleeve), not a diagnostic algorithm that requires expert interpretation for ground truth. The "ground truth" here would relate to the functional and safety specifications of the device itself, likely assessed through engineering tests and measurements.

    4. Adjudication Method for the Test Set

    • Not Applicable. As this is bench testing and not an expert-based ground truth establishment, adjudication methods like 2+1 or 3+1 are not relevant.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    • No. This is not an AI-powered diagnostic device, and therefore, an MRMC study is not applicable. The device is a reprocessed compressible limb sleeve.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • No. This is not an algorithm, so standalone performance is not relevant.

    7. The Type of Ground Truth Used

    • The "ground truth" for this comparative bench testing would be the functional and safety specifications of the original new device (Kendall Model 6325 SCD Sequential Compression System). The reprocessed devices were tested against how the original, new devices are expected to perform. This likely involved quantitative measurements of parameters like inflation pressure, cycle times, air leakage, material integrity, and biocompatibility (though the latter isn't explicitly detailed in the summary).

    8. The Sample Size for the Training Set

    • Not Applicable. This is not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Not Applicable. As there is no training set for an AI/ML algorithm.
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