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510(k) Data Aggregation

    K Number
    K090525
    Device Name
    LOI SYSTEM
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-06-01

    (95 days)

    Product Code
    ONG,GEX,OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K072459,K062991,K070284
    Why did this record match?
    Device Name :

    LOI SYSTEM

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

    The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.

    Device Description

    The LOI System is composed of a handpiece, base, power cord, charger, and pretreatment gel.

    AI/ML Overview

    This document describes the LOI System, an over-the-counter device intended for the treatment of periorbital wrinkles. The provided text is a 510(k) summary and approval letter, which primarily focuses on regulatory submission and substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria and performance metrics. Therefore, some of the requested information, such as precise acceptance criteria values, a detailed breakdown of device performance against these criteria, specific sample sizes for test/training sets, or details on human expert involvement beyond general clinical data collection, is not explicitly present in the provided text.

    Based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Safety Profile"The clinical studies demonstrated that the LOI System functions as intended and within an acceptable safety profile." (General statement)
    Effectiveness for periorbital wrinkles"The clinical studies demonstrated that the LOI System functions as intended and within an acceptable safety profile." (General statement)
    Compliance with US FDA performance standards"The device complies with the following U.S. Food and Drug Administration performance standards: 21 CFR §1040.10 & 1040.11." (General statement)
    Intended Use"The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles." (Intended use, not a performance metric)

    Missing Information: Precise quantitative acceptance criteria for safety and effectiveness (e.g., specific reduction in wrinkle severity, adverse event rates below a certain threshold) are not provided in this regulatory summary.

    2. Sample size used for the test set and the data provenance

    • Sample size for the test set: Not explicitly stated. The document mentions "multiple studies" and "clinical data was collected in multiple studies," but does not provide specific sample sizes for these studies or differentiate between test and training sets.
    • Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It is implied that the data was collected through "clinical studies," suggesting a prospective clinical trial, but no details are given.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Number of experts: Not specified.
    • Qualifications of experts: Not specified.

    4. Adjudication method for the test set

    • Adjudication method: Not specified.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • An MRMC study is not mentioned. This device is a direct-use aesthetic device, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable in the context of this device.

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

    • The LOI System is a physical light-based medical device for direct patient use, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. Its performance is inherent in its physical operation.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Given the "treatment of periorbital wrinkles" indication, the ground truth would likely be based on clinical assessment of wrinkle severity (e.g., using a standardized photographic scale, expert-graded visual assessment, or potentially instrumental measurements) and patient-reported outcomes. However, the specific methodology for establishing this ground truth is not detailed.

    8. The sample size for the training set

    • Not explicitly stated. The document mentions "multiple studies" for "clinical data" but does not differentiate training from test sets or provide specific numbers.

    9. How the ground truth for the training set was established

    • Not explicitly stated. As with the test set, it would likely involve clinical assessments of wrinkle severity, but the specific methodology is not detailed.
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