LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120735
    Device Name
    PATHASSIT LIGHT SEEKER
    Manufacturer
    Entellus Medical, Inc.
    Date Cleared
    2012-04-02

    (24 days)

    Product Code
    LRC,REG
    Regulation Number
    874.4420
    Type
    Special
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K113522
    Why did this record match?
    Device Name :

    PATHASSIT LIGHT SEEKER

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

    The PathAssist™ Light Seeker™ is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

    Device Description

    The PathAssist™ Light Seeker™ is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm - 3.5mm light guides (cables).

    AI/ML Overview

    PathAssist™ Light Seeker™ Acceptance Criteria and Study Details

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes a Class I medical device (ENT Manual Surgical Instrument), and as such, the focus of the performance data is on demonstrating its functional equivalence to a predicate device and meeting design specifications, rather than clinical performance metrics typically seen for diagnostic or therapeutic AI devices.

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Design Specifications & Functional EquivalenceCompatibility with LED light sources (2.5mm - 3.5mm light guides)Performance testing demonstrated compatibility with LED light sources.
    Device performs as intended (locating, illuminating, and transilluminating nasal and sinus structures)Performance testing demonstrated the subject device meets design specifications and performs as intended.
    Same indications for use as predicate deviceIndications for use are the same as the predicate device.
    Same fundamental scientific technology as predicate deviceFundamental scientific technology is the same as the predicate device.
    Same technological characteristics (principle of operation, design, function, materials, biocompatibility, reprocessing) as predicate deviceTechnological characteristics are the same as the predicate device.
    SafetyNo adverse events or safety concerns identified through performance testing relevant to this Class I device.Performance testing demonstrated the device is safe.
    EffectivenessAchieves its stated purpose (locating, illuminating, and transilluminating nasal and sinus structures).Performance testing demonstrated the device is effective.

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

    The document does not detail a "test set" in the context of clinical data for algorithmic performance. Instead, it refers to "design verification testing" and "functional testing." This type of testing typically involves a set number of devices or components to confirm manufacturing and functional parameters.

    • Sample Size for Test Set: Not explicitly stated, as this is not a clinical study involving patient data. The testing would have involved a sufficient number of manufactured devices or components to demonstrate consistent functionality.
    • Data Provenance: Not applicable in the context of clinical data. The testing was conducted by Entellus Medical, Inc. as part of its design verification process.

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

    Not applicable. This device is a manual surgical instrument, and its performance evaluation does not involve establishing ground truth through expert consensus on medical images or diagnoses. The "ground truth" here is adherence to design specifications and functional requirements.

    4. Adjudication Method for the Test Set

    Not applicable. Adjudication methods are typically used in studies involving subjective expert review (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. The performance testing for this device focused on objective functional parameters.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

    No. An MRMC comparative effectiveness study was not conducted for the PathAssist™ Light Seeker™. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a manual surgical instrument.

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

    No. This device is a manual surgical instrument and does not incorporate any AI algorithms. Its performance is entirely human-in-the-loop.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance evaluation was its design specifications and functional requirements. This includes ensuring compatibility with standard light guides, proper light emission, and adherence to physical design characteristics.

    8. The Sample Size for the Training Set

    Not applicable. As this device does not utilize AI or machine learning, there is no "training set."

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

    Not applicable. As this device does not utilize AI or machine learning, there is no "training set" and thus no ground truth to be established for it.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1