(165 days)
The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
The Trabecular Metal Vertebral Body Replacement (VBR) System is designed to be used as a replacement for a diseased or damaged vertebral body and the adjacent disc when spinal surgery is indicated. The Trabecular Metal VBR System is wholly comprised of Trabecular Metal Porous Tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.
This document does not contain information about studies that prove the device meets acceptance criteria as typically found for AI/ML medical devices.
The provided text (K070754) is a 510(k) summary for a physical medical device: the "Trabecular Metal™ Vertebral Body Replacement System." This type of device is a physical implant, not an AI/ML diagnostic or prognostic tool.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, MRMC studies, or standalone algorithm performance does not apply to this document.
The "Performance Data" section states: "The results of testing and analyses conducted demonstrate that the worst cases of the proposed System adequately meet the predetermined requirements established for its mechanical performance."
This refers to mechanical and material testing (e.g., fatigue strength, compression testing, biocompatibility) for a physical implant, not the kind of performance data, acceptance criteria, or study design relevant to AI/ML algorithms.
To directly answer your request based on the provided text, while acknowledging it's not an AI/ML device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined requirements established for its mechanical performance (e.g., strength, durability) | The worst cases of the proposed System adequately meet these predetermined requirements. |
2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not data from a test set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant to mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical implant, not an AI assistance tool for human readers.
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 (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For a physical device, the "ground truth" would be established engineering standards and specifications.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.