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510(k) Data Aggregation

    K Number
    K090278

    Validate with FDA (Live)

    Device Name
    ENSPIRE DEBRIDER SYSTEM
    Manufacturer
    SPINE VIEW, INC.
    Date Cleared
    2009-04-15

    (70 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K081051,K032473
    Predicate For
    K110992
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

    Device Description

    The SpineView ENSPIRE™ Debrider is a single-use discectomy device that is designed to cut and grind intervertebral disc material. Its auger mechaeo mechaeo um retrieves the excised debris and ejects it into a collection chamber.

    AI/ML Overview

    The provided documentation for K090278, the ENSPIRE™ Debrider System, describes the device's intended use and comparison to predicate devices, along with a summary of supporting data. However, it does not include specific acceptance criteria, a detailed study design with sample sizes for test or training sets, information about ground truth establishment (other than general biocompatibility and bench testing), or specifics about expert involvement or adjudication methods typically found in AI/ML device studies.

    This is because the ENSPIRE™ Debrider System is a physical medical device (a surgical tool for discectomy), not an AI/ML software device. Therefore, the types of studies and acceptance criteria applicable to AI/ML would not be relevant in this context. The evaluation focuses on physical characteristics, mechanical performance, biocompatibility, and intended use as a surgical instrument.

    Here's a breakdown of what can be extracted from the document, tailored as much as possible to the requested format, while acknowledging the inherent differences for a non-AI/ML device:

    1. Table of Acceptance Criteria and Reported Device Performance

    As this is not an AI/ML device, there are no "acceptance criteria" in the traditional sense of performance metrics like sensitivity, specificity, or AUC for an algorithm. Rather, performance is assessed through compliance with standards and demonstrating functionality.

    Acceptance Criteria (Implied from testing)Reported Device Performance
    Biocompatibility: Device materials are safe for human contact.Biocompatibility testing demonstrates that the device is in compliance with ISO 10993. (This implies it met the criteria set forth in ISO 10993 for relevant biological effects.)
    Bench Testing: Device functions as intended in a controlled environment and meets relevant standards/expectations for mechanical and operational performance.Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling. (This implies that the device successfully met predefined standards and functional requirements for cutting, grinding, and aspirating intervertebral disc material, likely including aspects like cutting efficiency, aspiration rate, structural integrity, etc.)
    Cadaver Testing: Device can be used safely and effectively as intended in a representative human anatomical model.Cadaver testing demonstrated that the device can be used as intended in humans. (This suggests that the device was able to successfully perform discectomy procedures on cadaveric spines, allowing for assessment of handling, effectiveness in removing disc material, and absence of obvious design flaws in a more realistic setting.)
    Substantial Equivalence: Device is as safe and effective as predicate devices.The device is found substantially equivalent in intended use and technology to the predicate devices (Stryker Dekompressor and SpineVu Endoscopic Spine System). This determination by the FDA is the ultimate "acceptance" criteria for 510(k) clearance.

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

    • Test Set Sample Size: Not explicitly stated.
      • Biocompatibility: ISO 10993 testing involves specific material samples and biological models, but exact numbers or types of tests are not given.
      • Bench Testing: Would involve multiple units of the device tested against various parameters, but specific sample sizes are not provided.
      • Cadaver Testing: The number of cadavers or spinal levels used is not specified.
    • Data Provenance:
      • The testing was conducted by SpineView, Inc., likely at their facilities or through contracted laboratories.
      • The data would originate from laboratory and cadaver studies, not from patient data in the typical sense of AI/ML studies (retrospective or prospective patient cohorts).

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Number of Experts & Qualifications: Not specified in the provided text.
      • For biocompatibility, experts would be toxicologists and material scientists.
      • For bench testing, engineers and quality assurance personnel would evaluate performance against specifications.
      • For cadaver testing, it would likely involve surgeons or medical professionals familiar with discectomy procedures, but the number and qualifications are not detailed.

    4. Adjudication method for the test set

    • Adjudication Method: Not applicable or not specified. Decisions in non-AI/ML device testing are typically based on objective measurements against pre-defined specifications and regulatory standards, rather than expert consensus on subjective interpretations. For cadaveric studies, observations by attending surgeons would guide the assessment.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

    • This question is Not Applicable as the ENSPIRE™ Debrider System is a physical surgical device, not an AI/ML diagnostic or assistive software. There are no "human readers" or "AI assistance" in this context.

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

    • This question is Not Applicable as the ENSPIRE™ Debrider System is a physical surgical device and does not involve an algorithm.

    7. The type of ground truth used

    • Type of Ground Truth:
      • Biocompatibility: Established through standardized tests against biological endpoints as defined by ISO 10993. The "ground truth" is that the material either passes or fails these established biological safety criteria.
      • Bench Testing: Engineering specifications and relevant industry standards serve as the "ground truth" for mechanical and functional performance (e.g., a certain cutting force must be achieved, or aspiration rate met).
      • Cadaver Testing: The ability of the device to effectively cut, grind, and aspirate disc material in an anatomical setting, without causing unforeseen damage or encountering significant operational difficulties. The "ground truth" is whether the device performed its intended function successfully and safely in the simulated surgical environment.
      • Substantial Equivalence: The performance and characteristics of the predicate devices serve as the "ground truth" for comparison.

    8. The sample size for the training set

    • This question is Not Applicable as the ENSPIRE™ Debrider System is a physical device and does not involve AI/ML requiring a training set.

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

    • This question is Not Applicable for the same reason mentioned above.
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