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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 or TiBrid™. SA plate and 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) premarket notification from the FDA for a medical device called the "Omnia Medical TiBrid™-SA System." This notification approves the device based on its substantial equivalence to previously cleared predicate devices. It does not describe a study conducted by the applicant to prove the device meets acceptance criteria, but rather summarizes how the device compares to predicate devices based on certain performance data.

Therefore, the requested information, specifically regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not present in the provided text. The document states that "Clinical Studies were not applicable to support a substantial equivalence determination for this device."

However, I can extract the non-clinical performance data type and the conclusion regarding substantial equivalence.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and explicit statements about what is not available:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable/not provided. The document refers to non-clinical (mechanical) testing, not a clinical test set with human or animal subjects.
• Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/not provided. Ground truth establishment by experts is typically associated with clinical studies involving human interpretation or diagnoses, which were not performed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/not provided. This relates to clinical study methodology, which was not performed.

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

• No, an MRMC comparative effectiveness study was not done. The device mentioned (Omnia Medical TiBrid™-SA System) is an intervertebral body fusion device (an implant), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical performance data, the "ground truth" would be the engineering specifications and established ASTM standards for implantable devices. Compliance with these standards confirms the device's mechanical integrity.

8. The sample size for the training set

• Not applicable. No training set for an algorithm was used as this is an implant device, not an AI/ML product.

9. How the ground truth for the training set was established

• Not applicable. No training set for an algorithm was used.

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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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