(241 days)
The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The Anterior Buttress Plate is a graft containment device that features a Ti plate fixed by a vertebral body screw. The Ti plate is connected to a PEEK buttress that extends over the adjacent intervertebral space maintaining the position of the bone graft.
The provided text is for a 510(k) summary for a medical device (Scient'X Anterior Buttress Plate), which falls under the category of spinal implants. These summaries are typically for demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than clinical studies with human subjects or AI performance metrics.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI standalone performance, training set size) are not applicable to this type of regulatory submission and information will not be found in the provided document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices | "Testing performed indicates the Scient'X Anterior Buttress Plate is substantially equivalent to predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission focuses on substantial equivalence based on mechanical testing and comparison to predicate devices, not on a clinical test set with human data as would be relevant for AI/diagnostic devices. The document does not specify sample sizes for mechanical tests, nor details about data provenance in the context of clinical studies.
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, in the sense of expert consensus for diagnostic accuracy, is not relevant to this type of device submission. The primary "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation of results (e.g., imaging). This is a mechanical device submission.
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 medical device (spinal implant), not an AI or diagnostic tool where MRMC studies would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical spinal implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is the performance characteristics and safety profiles of the legally marketed predicate devices. Substantial equivalence means the new device is as safe and effective as existing devices. This would be established through mechanical testing results compared to the predicate, and possibly design comparisons.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI or machine learning device.
§ 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.