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510(k) Data Aggregation

    K Number
    K072538
    Device Name
    PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
    Manufacturer
    UNITED MEDICAL SYSTEMS, INC.
    Date Cleared
    2008-01-30

    (145 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K032958,K010340,K012482,K011700,K053640,K062147
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

    Device Description

    The Piezolith 3000 Triple Focus consists of (1) a shock wave generator, which includes an adjustable therapy head/coupling mechanism mounted on an articulating arm or (when X·ray imaging is used) mounted to a swivel slide on C-arm (LITHOARM); (2) a control console (device trolley); (3) ultrasound imaging system for localization; (4) an optional X-ray system for localization; and (5) a treatment table.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Piezolith 3000 Triple Focus Extracorporeal Shock Wave Lithotripsy System. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against those criteria. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and performance metrics is not explicitly available in the provided document sections.

    However, based on the available information, here's what can be extracted and inferred:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Safety: Device functions as intended without posing new safety risks compared to predicate devices."In all instances, the Piezolith 3000 Triple-Focus functioned as intended and the results observed were as expected."
    Effectiveness: Device effectively fragments urinary stones in the kidney and ureter, comparable to predicate devices."Bench and clinical testing was performed using the Piezolith 3000 Triple Focus." The device is claimed to be "as safe and effective as the Piezolith 3000 (K032958), the Karl Storz Modulith Lithotripter (K010340, K012482, K011700), and the Direx Systems Corporation Integra (K053640, K062147)."
    Compliance with Standards: Device meets relevant electrical, medical device, and lithotripsy standards."the modified device was tested according to the following standards: IEC 60601-1 (1988) (including Amendment 1(1991) and Amendment 2 (1995)); IEC 60601-1-1 (2000) with Amendment 1, 1995; IEC 60601-1-2 (2001); IEC 60601-2-36 (1997); IEC 61846 (1998)."

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

    The document mentions "Bench and clinical testing" but does not specify the sample size for any clinical test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

    This information is not provided in the document. The study described is a comparison against predicate devices and adherence to standards rather than an independent expert-validated ground truth study.

    4. Adjudication Method for the Test Set

    This information is not provided as no specific "test set" requiring expert adjudication is detailed.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

    No, an MRMC comparative effectiveness study involving human readers and AI assistance is not mentioned in the document. This is a medical device (lithotripter), not an AI diagnostic tool that assists human readers.

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

    No, this is not an algorithm-only device. It's a physical medical device. The "performance data" refers to the device's physical capabilities and operational characteristics.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance demonstration is primarily:

    • Performance against predicate devices: The Piezolith 3000 Triple Focus is deemed "substantially equivalent" in safety and effectiveness to existing, legally marketed lithotripters. This implies that the accepted performance of previous devices serves as a benchmark.
    • Compliance with recognized standards: The device met specific IEC standards related to medical electrical equipment and lithotripters.
    • Functionality as intended: General statement about the device functioning as expected.

    No specific, independent "expert consensus, pathology, or outcomes data" is detailed as being used for a distinct "ground truth" to validate the device's primary efficacy in the context of this 510(k) summary.

    8. The Sample Size for the Training Set

    This information is not applicable/not provided. The Piezolith 3000 Triple Focus is a physical medical device, not a machine learning model that undergoes "training" on a dataset in the AI sense.

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

    This information is not applicable/not provided for the same reason as above.

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