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Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine 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 at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Spineart Juliet® Ti PO, OL & TL spinal implants consist of a range of intervertebral body spacers with various shapes and designs so as to be implanted via an open posterior or transforaminal approach and to adapt different patient's conditions. Spineart JULIET® Ti cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. Juliet® Ti PO, OL & TL spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. Juliet® Ti PO, OL & TL spinal implants are additively manufactured and present both solid and porous structures. The Juliet Ti cages are delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile).

This FDA document is a 510(k) premarket notification for the "Juliet® Ti" intervertebral body fusion device. While it describes the device and its claimed substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/human reader performance study.

The document details the device's indications for use, materials, and mechanical testing performed to demonstrate substantial equivalence to predicate devices. The "Discussion of Testing" section lists various mechanical tests conducted (e.g., static and dynamic axial compression, shear compression, subsidence, material characterization, static shear strength, fatigue shear strength, static tensile strength, and abrasion resistance). These tests assess the physical and mechanical properties of the implant, not the performance of an AI system or human readers.

Therefore, I cannot provide the requested information from this document. The questions you've asked (about sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance, and acceptance criteria tables for AI performance) are typical for the evaluation of AI/machine learning medical devices, which this document does not cover.

In summary:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical performance testing of a physical implant, not AI performance.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No AI test set is mentioned.
• 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 for AI performance is mentioned.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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