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510(k) Data Aggregation

    K Number
    K083157

    Validate with FDA (Live)

    Device Name
    HS AMICA
    Manufacturer
    H.S HOSPITAL SERVICE S.P.A.
    Date Cleared
    2009-09-29

    (340 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K053535
    Predicate For
    K150112,K223272
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HS AMICA is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.

    Device Description

    HS AMICA (Apparatus for MICrowave Ablation) is an integrated system for interstitial thermoablation of soft tissues through controlled emission of microwaves. The system is composed by three interactive devices, namely: AMICA-GEN: a digitally controlled microwave power source, operating at 2450 MHz and delivering up to 100 W CW (continuous wave); it features a single output channel. AMICA-PROBE: an interstitial single-use coaxial microwave applicator, fed by AMICA--GEN. AMICA-PUMP: a peristaltic pump for convective applicator cooling through continuous circulation of liguid coolant, fully controlled by AMICA-GEN.

    AI/ML Overview

    The provided text is a 510(k) summary for the HS AMICA Microwave Tissue Coagulation System. It describes the device's technical characteristics, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, specific device performance data (like sensitivity, specificity, accuracy), sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies.

    The "Performance testing" mentioned on page 3 is a general statement: "Performance testing was executed to ensure that HS AMICA functions as intended and meets design specifications. Sufficient data were obtained to show that the device meets safety and effectiveness criteria and is substantially equivalent to the predicate device." This statement, while confirming testing was done, does not provide any of the quantitative details requested.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and qualifications
    4. Adjudication method
    5. MRMC comparative effectiveness study details
    6. Standalone performance details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How the ground truth for the training set was established
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