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510(k) Data Aggregation

    K Number
    K163481
    Device Name
    HALF DOME Posterior Lumbar Interbody System
    Manufacturer
    Astura Medical
    Date Cleared
    2017-05-03

    (142 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K160154,K131082,K083714,K102067,K152512
    Why did this record match?
    Reference Devices :

    K160154, K131082, K083714, K102067

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

    The Half Dome Posterior Lumbar Intervertebral body fusion body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

    Device Description

    The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

    AI/ML Overview

    This document describes the Half Dome Posterior Lumbar Interbody System, a medical device, and does not provide information about an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI performance, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies) are not applicable.

    The acceptance criteria and study information provided pertain to the non-clinical testing performed to demonstrate substantial equivalence to predicate devices, as is typical for 510(k) submissions of this nature where clinical studies are not performed.

    Here's the information based on the provided text, focusing on the device's substantial equivalence:

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

    Acceptance Criteria (Demonstration of Substantial Equivalence)Reported Device Performance
    Mechanical Safety and Performance (Non-Clinical Testing)
    Static Compression (per ASTM F2077)Performed and found equivalent to predicate devices.
    Dynamic Compression (per ASTM F2077)Performed and found equivalent to predicate devices.
    Subsidence (per ASTM F2267)Performed and found equivalent to predicate devices.
    Push Out (per ASTM F-04.25.02.02 DRAFT)Performed and found equivalent to predicate devices.
    Intended UseEquivalent to predicate devices.
    DesignEquivalent to predicate devices.
    MaterialsEquivalent to predicate devices (Vestakeep®i4R PEEK per ASTM F2026, Tantalum per ASTM F560, Titanium alloy (Ti-6Al-4V ELI) per ASTM F136).
    Indications for UseEquivalent to predicate devices.

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

    • Test Set Sample Size: Not explicitly stated in terms of a "sample size" for a clinical or AI test set. Non-clinical testing typically involves a set number of physical samples for each test (e.g., several implants for compression testing). The document does not specify the number of implants tested for each mechanical test.
    • Data Provenance: The data is derived from non-clinical bench testing (mechanical tests) performed by the manufacturer, Astura Medical. There is no information on country of origin for this testing, nor is it retrospective or prospective in the clinical sense.

    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):

    • Not Applicable. The ground truth for this device's acceptance is established through compliance with established ASTM standards for mechanical testing and comparison to legally marketed predicate devices, not through expert consensus on interpretation of data like in an AI/ML context.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not Applicable. Adjudication methods are relevant for clinical studies or expert consensus, which were not performed for this 510(k) submission.

    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:

    • Not Applicable. This is not an AI-powered device, and no MRMC study was performed.

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

    • Not Applicable. This is not an AI-powered device.

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

    • For the non-clinical tests, the "ground truth" is defined by the performance requirements and methodologies outlined in the specified ASTM standards (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the identified predicate devices. The substantial equivalence argument posits that if the new device performs within acceptable limits established by these standards and similar to the predicate devices, it is safe and effective for its intended use.

    8. The sample size for the training set:

    • Not Applicable. This is not an AI-powered device.

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

    • Not Applicable. This is not an AI-powered device.
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