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510(k) Data Aggregation

    K Number
    K082310
    Device Name
    HOLLYWOOD, PACIFICA, REDONDO, VENTURA
    Manufacturer
    SEASPINE, INC.
    Date Cleared
    2008-11-10

    (89 days)

    Product Code
    MAX,MQP
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K091406,K103297,K122639,K131082,K133418,K142023,K142488,K142594,K152512,K153356,K162206,K173022,K173260,K192132,K193636,K201755,K213420
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

    When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.

    Device Description

    The SeaSpine Spacer System is an implantable device made from polyetheretherketone (PEEK) with markers for radiographic visualization. The device has a central canal for receiving bone graft and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.

    AI/ML Overview

    The SeaSpine Spacer System is an implantable device made from PEEK with markers for radiographic visualization. It is intended for spinal fusion procedures (L2-S1) as an intervertebral body fusion device and for vertebral body replacement (T1 to L5) in cases of tumor, trauma/fracture.

    Here's an analysis of the provided information regarding acceptance criteria and the study:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Appropriate properties for intended useMechanical testing results indicated that the SeaSpine Spacer System possessed appropriate properties for its intended use.
    Substantially equivalent to predicate devicesMechanical testing results indicated that the SeaSpine Spacer System is substantially equivalent to the predicate devices. Comparison in areas including use, design, materials, and function also showed substantial equivalence.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not detail a "test set" in the context of clinical or algorithmic performance. The study described is mechanical testing. Therefore, the concept of sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here as clinical data was explicitly not required.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    This information is not applicable as the study involved mechanical testing, not a clinical study requiring expert ground truth establishment.

    4. Adjudication Method for the Test Set

    This information is not applicable as the study involved mechanical testing.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. The document states, "Clinical data was not required for this device."

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    This is not applicable since the device is a physical medical implant and not a software algorithm.

    7. The Type of Ground Truth Used

    The ground truth used was based on mechanical testing results and comparison to predicate devices in terms of use, design, materials, and function to establish substantial equivalence.

    8. The Sample Size for the Training Set

    This information is not applicable as the study did not involve a training set for an algorithm or a clinical trial in the traditional sense. It was mechanical testing and comparison to predicate devices.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable. The "ground truth" for demonstrating the device's suitability was established through mechanical testing and direct comparison to legally marketed predicate devices based on their established performance and characteristics. The FDA determined "substantial equivalence" based on these comparisons.

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