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510(k) Data Aggregation

    K Number
    K030295
    Device Name
    LTU-904 PORTABLE LASER THERAPY UNIT
    Manufacturer
    RIANCORP PTY LTD
    Date Cleared
    2004-12-23

    (695 days)

    Product Code
    NZY
    Regulation Number
    890.5500
    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 LTU-904 is indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.

    Device Description

    The LTU-904 Laser Therapy Unit is a hand-held battery powered treatment device, is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Rian Corp LTU-904 Portable Laser Therapy System, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner typical for a device's performance benchmarks. Instead, it describes clinical outcomes that demonstrate the device's effectiveness. The closest approximation to acceptance criteria would be the clinically significant improvements observed.

    Interpretation of "Acceptance Criteria" based on reported study outcomes: The device is considered effective if it significantly reduces lymphedema volume, extracellular fluid (ECF), and is well-tolerated (no adverse effects).

    Acceptance Criteria (Implied from Study Outcomes)Reported Device Performance (LTU-904 Active Treatment)Placebo/Control Performance
    Reduction in affected arm volume (minimum 200 mL)31% of participants receiving 2 cycles of treatment (3 months after second cycle) achieved a ≥200 mL reduction.
    ~20% in Intent-to-Treat (ITT) analysis after 2nd active cycle.4% of those who received one cycle of placebo treatment.
    Significant reduction in Extracellular Fluid (ECF)52% of participants experienced a clinically significant decrease in ECF after 6 weeks of active laser.
    ECF significantly reduced in affected arm, trunk, and unaffected arm.19% of people who had placebo treatment achieved the same reduction.
    Safety / Adverse EffectsNo adverse effects from the laser treatments were observed by the investigators.Not explicitly stated for placebo, but generally expected to be none related to sham.

    2. Sample Size and Data Provenance

    • Sample Size (Test Set): A total of 64 post-mastectomy patients with at least 200 ml difference between their arms were enrolled in the study.
    • Data Provenance:
      • Country of Origin: Adelaide, Australia.
      • Retrospective or Prospective: The study was a prospective placebo-controlled double-blind clinical trial.

    3. Number of Experts and Qualifications for Ground Truth

    The document does not explicitly state the number of experts used to establish "ground truth" in the sense of independent expert review of images or diagnoses. Instead, the ground truth for treatment efficacy was established through objective clinical measures and subjective patient assessments.

    • Experts: The study was conducted at Flinders Medical Centre in Adelaide, Australia, under ethics committee approval. The assessments (ECF, whole arm volume, tonometry) were presumably performed by trained medical staff/researchers at the center. No specific number or qualifications for independent 'expert review' of outcomes are detailed beyond the conduct of the trial by clinical investigators.

    4. Adjudication Method

    The document describes the clinical trial design rather than an adjudication method for a test set.

    • Trial Design: The study was a placebo-controlled double-blind clinical trial. This means neither the participants nor the researchers administering the treatment and assessing outcomes knew whether the active or sham laser was being used. This inherently minimizes bias in assessment.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • Was an MRMC study done? No, the document describes a clinical trial comparing an active device to a placebo, not a comparative effectiveness study involving multiple human readers assessing cases with and without AI assistance.

    6. Standalone (Algorithm Only) Performance

    • Was a standalone study done? No, the device is a therapeutic laser system, not an algorithm. Its performance is assessed directly on patient outcomes in a clinical trial setting.

    7. Type of Ground Truth Used

    The "ground truth" for the device's effectiveness was established through:

    • Objective Clinical Measurements:
      • Extra Cellular Fluid (ECF)
      • Whole arm volume
      • Tonometry (tissue hardness)
    • Subjective Measures: Although not detailed, the text mentions "subjective measures" were used alongside objective ones.

    8. Sample Size for the Training Set

    • The document describes a clinical trial for evaluating device performance, not a study for training an algorithm or AI model. Therefore, there is no "training set" in the context of machine learning. The 64 patients were part of the evaluation study (test set).

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

    • As there was no training set for an algorithm, this question is not applicable. The ground truth for the clinical trial patients (the "test set" in this context) was established by the objective and subjective measures outlined in point 7.
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