(28 days)
The ROI-T System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI-T may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.
The ROI-T implants are crescent shaped blocks in a variety of heights and lordosis angles. The shape of the ROI-T allows for a larger implant (length and width) to be used. The ROI-T implants are provided in both an open and enclosed graft design. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.
The provided text is a 510(k) summary for the LDR Spine ROI-T System, which is a spinal partial vertebral body replacement device. This summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (mechanical testing), rather than detailed clinical studies with acceptance criteria for device performance as would be expected for an AI/ML medical device.
Therefore, many of the requested fields regarding acceptance criteria and study details for an AI/ML device cannot be extracted from this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document in the context of specific performance metrics or acceptance criteria typically seen for AI/ML devices. The document states:
- "Mechanical test results demonstrate that the proposed ROI-T System is substantially equivalent to the predicate device."
This implies that the acceptance criteria for the ROI-T system were to demonstrate mechanical properties (strength, stability, etc.) that were comparable to or better than those of the predicate device (LDR Spine ROI System, K043349). However, the specific numerical values of these criteria or the reported performance metrics are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The study mentioned is "mechanical test results," which are non-clinical and do not involve human patient data or test sets in the context of AI/ML evaluation.
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. Ground truth establishment by experts is relevant for clinical or diagnostic AI/ML studies, not for mechanical testing of a medical implant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly for establishing ground truth from expert opinions, which is not relevant here.
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 mechanical device, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing, the "ground truth" would be established by validated engineering standards and testing methods. The document does not specify these methods but implies adherence to relevant standards for spinal implants.
8. The sample size for the training set
Not applicable. This isn't an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This isn't an AI/ML device that requires a training set or ground truth in that context.
§ 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.