(27 days)
The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Valeo™ VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.
The Valeo™ VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial or total corpectomy. The Valeo™ VBR is manufactured from MC2, a ceramic material. The Valeo M VBR is for single level anterior spinal use from T1-L5.
The provided text is a 510(k) summary for the Valeo™ VBR device. It details the device's indications for use and states its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, specific performance studies (like accuracy or efficacy), sample sizes for test or training sets, ground truth establishment, or expert involvement for evaluating device performance. The document primarily addresses regulatory aspects for clearance.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the provided text, along with the reasons why other information is missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the text. The document states that "Testing performed indicates that the Valeo™ VBR is substantially equivalent to predicate devices," but it does not specify what "testing" was done, what the acceptance criteria for that testing were, or what the quantitative results of that testing were. | The device was found to be "substantially equivalent" to the predicate devices (Amedica Valeo™ VBR System cleared in K073125 and the ARX Spinal System cleared in K051525). This implies that its performance met the standards demonstrated by the predicate devices, but no specific performance metrics are given. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the text. The document refers to "testing performed" but does not detail any specific test sets, their sample sizes, or data provenance. This 510(k) summary is focused on demonstrating substantial equivalence, usually through comparison of design, materials, and potentially bench testing results, rather than clinical study data unless specifically required for novel aspects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided in the text. Since no specific test set or clinical study for evaluating the device's performance (e.g., accuracy of a diagnostic device) is described, there is no mention of experts establishing ground truth. The device is a spinal implant, and its "performance" is generally assessed via mechanical and material testing, and comparison to existing devices, rather than expert-adjudicated clinical outcomes in the context of a 510(k) summary.
4. Adjudication method for the test set:
- Not applicable/Not provided in the text. As no specific test set or study requiring adjudication is mentioned.
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 device is a vertebral body replacement implant, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided in the text. In the context of a spinal implant 510(k), "ground truth" typically relates to mechanical properties, biocompatibility, and intended function matching predicate devices. The document does not specify any particular type of ground truth beyond demonstrating substantial equivalence in these areas.
8. The sample size for the training set:
- Not applicable/Not provided in the text. As this is not an AI/ML device, the concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established:
- Not applicable/Not provided in the text.
In summary, the provided document is a regulatory 510(k) summary for a spinal implant, focusing on its substantial equivalence to predicate devices, rather than on detailed performance metrics from a clinical study or AI model evaluation. Therefore, most of the questions relating to performance criteria, study design, and expert involvement for "acceptance criteria" for an AI or diagnostic device are not applicable or not provided in this 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.