LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222473
    Device Name
    EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
    Manufacturer
    Medos-International, SARL
    Date Cleared
    2022-10-13

    (58 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K200245
    Why did this record match?
    Device Name :

    EXPEDIUM**®** Spine System, EXPEDIUM VERSE**®** Spine System: ALTALYNE™ Ultra Rods

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

    The EXPEDIUM Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

    The EXPEDIUM Spine System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.

    When used for posterior non-cervical pediativ patients, the EXPEDIUM Spine System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    The EXPEDIUM VERSE Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

    The EXPEDIUM VERSE Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients. the EXPEDIUM VERSE Spine System metallic implants are indicated as an adjunct to freat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM VERSE Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis. fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM VERSE Spine System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

    Device Description

    The EXPEDIUM Spine System and the EXPEDIUM VERSE Spine System consists of metallic implants intended to provide immobilization and stabilization of spinal segments. The EXPEDIUM Spine System and the EXPEDIUM VERSE Spine System also consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, set screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers.

    AI/ML Overview

    I apologize, but the provided text does not contain information about an AI/ML medical device, its acceptance criteria, or a study proving its performance. The document is an FDA 510(k) clearance letter for a traditional medical device, specifically the EXPEDIUM® Spine System and EXPEDIUM VERSE® Spine System with ALTALYNE™ Ultra Rods.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and reported device performance for an AI/ML device.
    2. Sample sizes or data provenance for a test set in an AI/ML study.
    3. Number and qualifications of experts for ground truth establishment in an AI/ML context.
    4. Adjudication method for an AI/ML test set.
    5. MRMC comparative effectiveness study results for AI assistance.
    6. Standalone performance of an AI algorithm.
    7. Type of ground truth used for an AI/ML study.
    8. Sample size for a training set in an AI/ML study.
    9. How ground truth for a training set was established for an AI/ML study.

    The document discusses the substantial equivalence of the spinal system to predicate devices based on mechanical testing, corrosion and wear testing, magnetic resonance testing, and biocompatibility testing. It focuses on the safety and effectiveness of the physical implants, not on any digital or AI-driven diagnostic or therapeutic aid.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1