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510(k) Data Aggregation

    K Number
    K222490
    Device Name
    HBL Blade Assembly
    Manufacturer
    Hand Biomechanics Lab, Inc
    Date Cleared
    2022-11-14

    (89 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K181819
    Why did this record match?
    Device Name :

    HBL Blade Assembly

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

    The HBL Blade Assembly is indicated for use with the 3M Agee Inside Job Carpal Tunnel Release System or MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:

    • Carpal tunnel release in the wrist
    • Cubital tunnel in the elbow
    Device Description

    The HBL Blade Assembly is a surgical device designed to divide the ligament during an endoscopic carpal tunnel release (ECTR) or the fascia during an endoscopic cubital tunnel release (ECuTR). This device is capable of elevating a cutting blade from a retracted position within the cannula to an exposed position for cutting the ligament or fascia. Once the ligament or fascia has been divided, the cutting blade can be returned to a safe position within the cannula.
    The HBL Blade Assembly is composed of a probe assembly that is fabricated using medical grade injection molded plastic, and both a spring and cutting blade that are fabricated using stainless steel. The Blade Assembly is provided sterile and designed for single use.

    AI/ML Overview

    The provided text is a 510(k) summary for the HBL Blade Assembly. It describes the device, its indications for use, comparison to a predicate device, and performance data. However, it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria using an AI/ML context.

    The document discusses performance data related to mechanical aspects and a cadaveric study, which are typical for mechanical medical devices, not AI/ML-driven devices. There is no mention of algorithms, machine learning, AI models, or human-in-the-loop studies in the context of diagnostic accuracy improvement.

    Therefore, I cannot provide the requested information from the given text as it relates to an AI/ML device. The device described, the HBL Blade Assembly, is a surgical tool, and its performance evaluation involves physical and mechanical properties, as well as surgical use in a cadaveric setting, not the kind of AI/ML performance metrics you've asked about.

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