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510(k) Data Aggregation

    K Number
    K032698
    Device Name
    COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
    Manufacturer
    COAPT SYSTEMS, INC.
    Date Cleared
    2003-10-23

    (51 days)

    Product Code
    GAM,IIW
    Regulation Number
    878.4493
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K023992,K014153,K974309
    Why did this record match?
    Device Name :

    COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE

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

    The ENDOTINE MidfaceTM-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

    Device Description

    The ENDOTINE Midface™-ST 4.5 consists of insertion tools and bioabsorbable implants. The device implant consist of two components: (1) a fixation platform attached to an anchoring leash, and (2) an anchoring tack. This device along with its institution tools are supplied sterile for single use only.

    AI/ML Overview

    The provided text describes a 510(k) summary for the ENDOTINE Midface™-ST 4.5 Device, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving device performance against those criteria.

    Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

    Here's a breakdown of what can be extracted and what cannot:

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

    The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a tabular format. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to general standards.

    Acceptance Criteria (Inferred)Reported Device Performance
    Similarity to predicate devices in design, materials, and functionThe device is substantially equivalent to predicate devices (ENDOTINE Forehead, PDS II Suture, Lactosorb Panels) in design, materials, and fundamental scientific technology.
    Compliance with user specifications and USP Standards for absorbable surgical suturesPerformance data meet applicable standards and fulfill device requirements as defined in user specifications and USP Standards for absorbable surgical sutures.
    Safety and appropriateness for intended useSafe and appropriate for intended use due to similarity to predicate devices, extensive cadaver modeling/evaluations, and positive user feedback. No new issues of safety or effectiveness raised.

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

    • Sample size for test set: Not mentioned. The document refers to "extensive cadaver modeling and evaluations" but does not specify a sample size for these evaluations related to performance testing.
    • Data provenance: Not explicitly stated as a test set. The "cadaver modeling and evaluations" would typically be prospective laboratory/pre-clinical data. The "user observation from several leading surgeons" is feedback, not a structured test set.

    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. The document mentions "several leading surgeons" provided feedback and user observation, but it doesn't describe their role in establishing a ground truth for a test set.
    • Qualifications of experts: Described as "leading surgeons," but no specific details on their experience (e.g., years of experience, specialization) are provided.

    4. Adjudication method for the test set

    • Adjudication method: Not mentioned. No dedicated "test set" with ground truth established through adjudication is described.

    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: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

    • Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

    7. The type of ground truth used

    • Ground truth: Not explicitly defined in the context of a "test set" for performance evaluation against a specific clinical outcome. The nearest equivalents are:
      • Predicate devices: The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices.
      • USP Standards: Compliance with established industry standards for absorbable sutures.
      • User specifications: Device requirements as defined by user needs.

    8. The sample size for the training set

    • Sample size for training set: Not applicable based on the information provided. The document describes pre-clinical evaluations (cadaver modeling) and feedback, not a formalized "training set" in the context of machine learning.

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

    • Ground truth for training set: Not applicable. As there's no mention of a training set, the establishment of its ground truth isn't discussed.
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