(280 days)
The K-Centrum Anterior Spinal Fixation System is intended for alignment correction and stabilization of the thoracolumbar spine. The K-Centrum is also intended to provide stabilization to augment the development of a solid spinal fusion. The K-Centrum is intended for threaded anchor/ fixation attachment to the anterolateral intervertebral bodies from T10 to L2 only and not more than 2 motion segments. The K-Centrum is indicated for vertebral body fractures and tumors.
The K-Centrum Anterior Fixator is intended for correction and stabilization of the spine. The K-Centrum is also intended to provide temporary stabilization and augment the development of a solid spinal fusion. The K-Centrum is intended for screw/bolt/fixation attachment to the anterolateral intervertebral bodies from T10 to L5 only and less than 4 motion segments.
The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.
The K-Centrum Anterior Spinal Fixation System is a multi-component system. The construct utilizes all of the following implantable components: Vertebral Body Anchors (Two); Linkage rod (One); Set screws (Two); Locking caps (Two). The K-Centrum System includes unique instrumentation to assist the surgeon in placing the anchors parallel to each other.
The provided text describes a 510(k) premarket notification for the K-Centrum Anterior Spinal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device through technological comparisons and mechanical testing, rather than clinical performance or AI-driven acceptance criteria. Therefore, most of the requested information regarding AI device evaluation is not applicable to this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Perform comparably to the predicate device (Z-Plate). | "Results from comparative mechanical testing results shows that the K-Centrum performs comparably to the Z-Plate." |
| Exceed minimum performance requirements outlined in the FDA guidance document, "Device Considerations for Spinal Fixation Device Systems", FDA, 1993. | "both devices exceed the minimum performance requirements outlined in the FDA guidance document, 'Device Considerations for Spinal Fixation Device Systems', FDA, 1993." |
| No new types of safety or effectiveness questions raised. | "No new types of safety or effectiveness questions were raised as a result of the testing or risk analysis performed for the K-Centrum Anterior Spinal Fixation System." |
| Material composition (Ti-6A1-4V, ELI) in accordance with ASTM F 136 - 96. | "Both devices are manufactured from the same titanium alloy (Ti-6A1-4V, ELI), in accordance with the same standard material specification (ASTM F 136 - 96)." |
| Similar design features (anchors, longitudinal elements, locking mechanisms). | "Both system configurations include anchors, longitudinal elements for linkage, and locking mechanisms." (Details on differences in anchor geometry for direct bone contact, rod shape, and locking mechanism are also noted, but deemed substantially similar) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "testing" and "results from comparative mechanical testing" but does not quantify the number of units or tests conducted for the mechanical evaluations.
- Data Provenance: Not specified. The data appears to be from in-vitro mechanical testing conducted by the manufacturer, Spineology, Inc. There is no mention of clinical data, country of origin related to patient data, or whether it was retrospective or prospective.
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. This device is a spinal fixation system, and the evaluation described is based on mechanical testing standards and engineering comparisons to a predicate device, not on expert-adjudicated ground truth as would be relevant for an AI system. The FDA guidance document itself would represent a consensus of expert knowledge in biomechanical testing, but not individual expert adjudication of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human-based assessment of data, typically in diagnostic or prognostic studies, not to mechanical testing of physical devices against established standards.
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 not an AI device. The study described is a mechanical comparison of a medical implant to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance is based on established mechanical testing standards (ASTM 1717-96) and FDA guidance document "Device Considerations for Spinal Fixation Device Systems" (1993). The comparison to the predicate device (Z-Plate ATL Anterior Fixation System) also serves as a benchmark for "comparable" performance.
8. The sample size for the training set
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device, so there is no "training set" or ground truth for it 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.