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The TiBrid™-SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation.

The TiBrid™-SA is a standalone device and must be used with the internal bone screws provided.

The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system used in the spine to replace a collapsed, damaged, or unstable disc. The implantable devices are manufactured from PEEK-OPTIMA™ HA Enhanced, titanium alloy, and tantalum for radiographic visualization. Each device is available in multiple footprints, heights, and angles. The implants feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and integrated fixation.

The provided document is a 510(k) Pre-market Notification from the FDA regarding the Omnia Medical TiBrid™-SA. It pertains to a medical device (an intervertebral body fusion device), not an Artificial Intelligence (AI) or machine learning (ML) device. Therefore, the document does not contain information about acceptance criteria or studies related to AI/ML device performance, such as sensitivity, specificity, or reader studies.

The "acceptance criteria" discussed in this document refer to the criteria for demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance. This section:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI/ML device. The document mentions mechanical testing according to ASTM standards for the physical intervertebral body fusion device.
2. Sample sized used for the test set and the data provenance: Not applicable for AI/ML device performance. Mechanical testing is described, but specific sample sizes for these tests are not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for AI/ML device performance.
4. Adjudication method: Not applicable for AI/ML device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone performance study was done: Not applicable for AI/ML device performance. The device itself (the fusion device) undergoes mechanical testing.
7. The type of ground truth used: Not applicable for AI/ML device performance. For the mechanical device, "ground truth" would be related to compliance with ASTM standards in laboratory testing.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

The document primarily focuses on demonstrating that the Omnia Medical TiBrid™-SA System is substantially equivalent to legally marketed predicate devices based on:

• Indications for Use
• Technological Characteristics (design features, intended use, materials, dimensions, function)
• Results of mechanical testing (static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, and expulsion testing).

The document is a regulatory approval letter for a physical medical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool.

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