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510(k) Data Aggregation
(50 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative criteria, but implicitly refers to equivalence with predicate devices under specific ASTM standards. | Non-clinical tests demonstrated compliance with ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices by performing static and dynamic compression shear testing. |
| The mechanical testing results, material, indications and intended uses, and device function are comparable to the predicate device. |
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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(455 days)
The TiBrid™ SC standalone cervical fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.
The TiBrid™-SC system consists of a standalone hybrid PEEK OPTIMA™ HA Enhanced and titanium alloy cervical interbody device with 3 titanium plate options (two, three, and four screws) that can be connected to the standalone device. The standalone cages are available in multiple footprints and heights, and have a lordotic angle of 6°. The plates are available in multiple heights. The cages 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.
The provided text describes a 510(k) premarket notification for a medical device (Omnia Medical TiBrid™-SC) and does not contain information about the acceptance criteria or a study proving the device meets those criteria for an AI/ML product.
The document is a submission to the FDA for an intervertebral body fusion device, which is a physical implant used in spinal surgery, not a software or AI/ML-based device. The "acceptance criteria" discussed in the document are about demonstrating substantial equivalence to existing predicate devices based on design, materials, dimensions, function, and mechanical testing results (e.g., static and dynamic compression, subsidence, expulsion testing).
Therefore, I cannot extract the requested information regarding an AI/ML device's acceptance criteria and study from this document. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are relevant to the evaluation of AI/ML products, but not to the type of medical device described in this 510(k) submission.
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