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510(k) Data Aggregation

    K Number
    K040417
    Device Name
    PILLAR PALATAL IMPLANT SYSTEM
    Manufacturer
    RESTORE MEDICAL INC.
    Date Cleared
    2004-07-28

    (161 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K011723,K982717,K972023
    Why did this record match?
    Reference Devices :

    K011723, K982717, K972023

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

    The Pillar™ Palatal Implant System is intended for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).

    Device Description

    The Pillar™ Palatal Implant System (“System”) is intended as a treatment option for snoring and obstructive sleep apnea. The System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring. Additionally, the implants reduce the incidence of airway obstruction caused by the soft palate.

    The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Pillar™ Palatal Implant System, detailing its intended use, design, and equivalence testing to predicate devices. However, the document does NOT contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested quantitative data regarding sample sizes, expert involvement, or ground truth establishment.

    Therefore, many of the requested fields cannot be filled from the provided text.

    Here's a breakdown of what can and cannot be answered based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Not specified in the document. The document states "The clinical results were compared to the clinical results of other products which have an indication for the treatment of OSA. The results were comparable in terms of performance." This implies criteria were met, but the specific metrics and targets are not detailed."The clinical results were comparable in terms of performance" to predicate devices for OSA treatment. "Clinical data demonstrates the device performs as anticipated and raises no new questions of safety and effectiveness over the predicate devices."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size (Test Set): Not specified.
    • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "clinically evaluated" without further detail.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

    4. Adjudication method (e.g. 2+1, 3+1, none) 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

    • MRMC Study: No, this is a physical implant device, not an AI or imaging diagnostic device.
    • Effect size of AI assistance: Not applicable.

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

    • Standalone Performance: Not applicable as this is a physical medical device.

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

    • Type of Ground Truth: The document implies "clinical results" and "performance" related to the treatment of OSA and snoring. This likely refers to patient outcomes or physiological measurements (e.g., AHI reduction, snoring intensity), but the specific metrics used as "ground truth" are not explicitly stated.

    8. The sample size for the training set

    • Sample Size (Training Set): Not applicable. The device is a physical implant tested in a clinical trial, not an algorithm that undergoes a "training" phase.

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

    • Ground Truth Establishment (Training Set): Not applicable.
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