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510(k) Data Aggregation

    K Number
    K200070

    Validate with FDA (Live)

    Device Name
    ARx Spinal System
    Manufacturer
    Life Spine Inc.
    Date Cleared
    2020-04-23

    (101 days)

    Product Code
    NKB,KWP,KWQ
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K151196,K191575
    Predicate For
    K202836,K203163,K210549,K220025,K220341
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis . It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

    In order to achieve additional levels of fixation in skeletally mature patients, the ARx Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

    Device Description

    The ARx Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX Spinal System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Spinal System screw assembly component. The ARX Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX Spinal System components with the components from any other system or manufacturer.

    AI/ML Overview

    The provided text is a 510(k) premarket notification summary for a medical device, the ARx Spinal System. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a clinical study or AI/software analysis.

    Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/machine learning enabled device. The "Performance Data" section specifically mentions mechanical testing (ASTM F1717 & F1798) to demonstrate substantial equivalence to a predicate device, which is typical for implantable orthopedic devices, not diagnostic or AI-powered tools.

    To directly answer your request based on the provided text:

    1. A table of acceptance criteria and the reported device performance: Not applicable. The document refers to mechanical performance testing against ASTM standards to show equivalence, not clinical performance metrics or AI algorithm performance. No acceptance criteria table or reported performance for an AI/software device is present.

    2. Sample sizes used for the test set and the data provenance: Not applicable. The "performance data" refers to mechanical testing of the device itself, not a test set of data for an AI algorithm. No information on data provenance (country, retrospective/prospective) is provided as it's not relevant to this type of device submission.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for an AI algorithm test set is mentioned.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.

    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 document pertains to an implantable spinal system, not an AI-assisted diagnostic device.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no AI algorithm in scope for this submission.

    8. The sample size for the training set: Not applicable. There is no AI algorithm described.

    9. How the ground truth for the training set was established: Not applicable. There is no AI algorithm described.

    In summary, the provided FDA 510(k) clearance letter and summary are for an orthopedic implant (ARx Spinal System) and detail the process of demonstrating substantial equivalence primarily through design, materials, indications for use, and mechanical testing, not through clinical trials or performance assessments of AI/software for diagnostic purposes.

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