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510(k) Data Aggregation

    K Number
    K182617
    Device Name
    ATEC IOM Accessory Instruments
    Manufacturer
    Alphatec Spine, Inc
    Date Cleared
    2019-05-09

    (227 days)

    Product Code
    PDQ,ETN
    Regulation Number
    874.1820
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K183705,K161363,K133221,K123623,K110170,K171807,K142438,K182542
    Why did this record match?
    Reference Devices :

    K183705, K161363, K133221, K123623, K110170

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

    The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

    Device Description

    The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws).

    AI/ML Overview

    The document provided is a 510(k) premarket notification for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, functionality, and performance testing. However, it explicitly states:

    "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

    This means the submission does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human-in-the-loop studies involving AI. The acceptance criteria and performance data provided are related to functional, electrical safety, biocompatibility, and reprocessing aspects of the surgical instruments themselves, not their performance in a clinical diagnostic or prognostic context with AI assistance.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/clinical performance study.

    The document covers the following types of acceptance criteria and proven performance for the ATEC IOM Accessory Instruments (which are surgical tools, not an AI diagnostic device):

    1. Table of Acceptance Criteria and Reported Device Performance (Summary of Engineering/Safety Tests):

    TestAcceptance Criteria (Implied by Test Method)Reported Device Performance
    Functional performance testing and verification analysisInsulation Effectiveness, Electrical Resistance, Current Density (as per standard engineering principles for electrical stimulation instruments)"All functional performance testing passed. Substantial equivalence has been shown via analysis and testing."
    Electrical safety testing and/or evaluationCompliance with IEC 60601-1: 2005 for medical electrical equipment."Subject devices passed electrical safety testing and/or evaluation, demonstrating that the devices meet the requirements."
    Biocompatibility testingCompliance with ISO 10993 for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility. Risk analysis performed considering body contact and duration."A risk analysis was performed taking into account nature of body contact and duration to categorization the use of existing data, end-specific testing, and endpoint assessment to cover the identified test methods. Additionally, data was leveraged by other means (e.g., authorized use of Master File, predicate and reference devices, well known and characterized materials) to support the biocompatibility of the subject devices."
    Reprocessing (Cleaning and Sterilization)Cleaning validation study based on AAMI TIR30:2011 acceptance criteria. Steam sterilization validation performed per ANSI/AAMI/ISO 17665-1:2006/(R)2013 to assure an SAL of 10^-6."The subject devices can be adequately cleaned and steam sterilized prior to use."

    The document does NOT provide information for the following points, as they are not relevant to a device submission for surgical instruments focused on substantial equivalence based on material and functional safety rather than AI performance:

    1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
    2. 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)
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
    4. 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
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
    7. The sample size for the training set
    8. How the ground truth for the training set was established
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