LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980761
    Device Name
    SYNTHES SPINE PEDIATRIC ROD SYSTEM
    Manufacturer
    SYNTHES SPINE
    Date Cleared
    1998-08-04

    (158 days)

    Product Code
    MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K962984
    Why did this record match?
    Reference Devices :

    K962984

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

    When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (LS-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The SYNTHES Spine Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.

    Device Description

    The SYNTHES Spine Pediatric Rod System consists of rods. clamps and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295). The rod is provided in four lengths, 80, 120, 240 and 300mm. The rod diameter is 3.5mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw. a 4.0mm cancellous screw. or a 4.0mm or 4.35mm cxpansion screw with 1.8mm locking screw.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study data where available.

    This submission describes a device equivalency claim rather than a study against a pre-defined set of acceptance criteria. The SYNTHES Spine Pediatric Rod System is compared to a predicate device (Acromed ISOLA Pediatric Components, K962984) to establish substantial equivalence, meaning it's assumed to be as safe and effective as the already-marketed predicate. Therefore, many of the typical study-related questions (like sample size, experts for ground truth, etc.) are not directly applicable in the same way they would be for a de novo device performance validation study.

    Acceptance Criteria and Reported Device Performance

    For this 510(k) submission, there are no explicit numerical acceptance criteria as would be found in a performance study trying to validate a new device against a benchmark. Instead, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device.

    Acceptance Criteria (Implicit for Substantial Equivalence)Reported Device Performance / Justification
    Intended Use: Device for grade 3 or 4 spondylolisthesis at L5-S1 vertebral joint, utilizing autologous bone graft, to be removed after solid fusion, for pediatric patients ≤ 50lbs.Stated Identical Indications for Use: The SYNTHES Spine Pediatric Rod System is described with the same indications for use as the predicate (Acromed ISOLA Pediatric Components). The FDA's acceptance letter reiterates these specific, limited indications.
    Technological Characteristics: Similar design principle (rods, clamps, screws), materials, and dimensions to the predicate.Description of Device: The device consists of rods (3.5mm diameter, 4 lengths), clamps, and screws (3.5mm cancellous, 4.0mm cancellous, 4.0mm or 4.35mm expansion with 1.8mm locking screw). Materials are commercially pure grade 4 Titanium (screws) and titanium alloy TAN (clamps and rods). This aligns with the expectation of similarity to existing pedicle screw systems.
    Performance (e.g., mechanical strength, biomechanical stability, biocompatibility): Adequate for the intended use and equivalent to the predicate device.Implied by Substantial Equivalence: While no specific test results are provided in this summary, a 510(k) typically includes non-clinical performance data (e.g., mechanical testing, materials testing) to demonstrate that the new device performs as safely and effectively as the predicate for its intended use. The FDA's acceptance implies that these data were satisfactory.
    Sterile Status: Provided non-sterile with recommended sterilization method.Non-Sterile: Device is provided non-sterile; moist heat sterilization is recommended. This is a common characteristic for many implantable devices.

    Study Information (Based on 510(k) Equivalence)

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

      • N/A. This 510(k) is a claim of substantial equivalence to an existing device (predicate) rather than a clinical study with a test set of patients or data samples. The "data" provided would typically be engineering specifications, material properties, and mechanical test results (non-clinical). Clinical data, if any, would likely be for the predicate device, not a specific "test set" for the SYNTHES device.

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

      • N/A. Ground truth, in the context of clinical outcomes, is not directly established for this 510(k) submission on a "test set." The evaluation is regulatory, comparing the new device's features and performance data (usually non-clinical mechanical or material tests) to known predicate device characteristics.

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

      • N/A. This is not a clinical efficacy or performance study involving human readers or adjudicated outcomes.

    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:

      • N/A. This is a medical device (spinal implant) 510(k) submission, not an AI or imaging diagnostic device. MRMC studies are not relevant here.

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

      • N/A. See point 4.

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

      • N/A. For this 510(k) submission, the "ground truth" for the device's acceptable performance is largely derived from:
        • Predicate device's established safety and effectiveness: The FDA has previously cleared the Acromed ISOLA Pediatric Components (K962984).
        • Engineering and materials standards: Compliance with ASTM standards for Titanium (F67, F1295) indicates material suitability.
        • Non-clinical performance data: Typically, mechanical bench testing (e.g., fatigue, static strength) is submitted in a 510(k) dossier to show the device meets or exceeds the performance of the predicate. This data serves as the "ground truth" for its mechanical properties.

    7. The sample size for the training set:

      • N/A. There isn't a "training set" in the context of this device's regulatory pathway. Design and engineering would rely on engineering principles, material science, and the existing knowledge base for spinal implants.

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

      • N/A. See point 7.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1