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The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.

The TranS1® Lateral Interbody Fusion Device is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also includes curved access instruments and disc preparation instruments. The TranS1® Lateral Interbody Fuson Device provides a lateral approach to the spine from a posterior angle while the patient is in a prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and the patient is already in the prone position which eliminates the need to flip the patient for supplemental posterior fixation. It is designed for use to provide structural stability in skeletally mature individuals.

The provided document is a Premarket Notification [510(k)] Summary for the TranS1® Lateral Interbody Fusion Device. It details the device's indications, description, and claims of substantial equivalence to predicate devices, supported by mechanical testing. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

Summary of Testing (as provided):

The document states:
"Mechanical testing for the TranS1 Lateral Interbody Fusion Device was performed per ASTM standards and included Static Axial Compression Strength (ASTM 2077-03), Static Subsidence (ASTM 2267-04), Static Push-out (ASTM Draft Standard F-04.25.02.02 and ASTM 2077-03) and Dynamic Axial Compression (Fatigue) (ASTM 2077-03). All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. No new safety or effectiveness questions were raised as a result of the testing."

This indicates that the acceptance criteria for the mechanical testing were established by ASTM standards and the test protocol, and the device met or exceeded these requirements. However, specific numerical acceptance criteria and reported performance values are not detailed in this summary.

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