(72 days)
The Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.
The Trinica® Anterior Lumbar Plate (ALP) System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V ELI).
The Trinica Anterior Lumbar Plate System is supplied with the instrumentation necessary for implantation of the system. The Trinica" Anterior Lumbar Plate System is for single use only.
The provided documentation focuses on a 510(k) summary for the Zimmer Spine Trinica® Anterior Lumbar Plate System, which is a medical device for spinal fixation. This type of submission typically demonstrates substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI/ML device would.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment is not applicable to this document. The document describes a sterilization validation as the primary "performance testing" conducted.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device meets design controls for sterilization. | Sterilization testing of the components/instruments contained in the subject Trinica ALPS tray was conducted. The test results demonstrated the modified device met the requirements of ISO 17665 and AAMI TIR12. |
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 does not detail a "test set" for a performance study in the context of diagnostic accuracy. The performance testing was related to sterilization validation.
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 context of expert review, is not relevant to sterilization validation.
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 device is a spinal implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This device is a spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For sterilization validation, the "ground truth" would be the successful killing of microorganisms, which is assessed through specific microbiological testing methods and standards (ISO 17665, AAMI TIR12).
8. The sample size for the training set:
- Not Applicable. There is no "training set" for this type of medical device submission.
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.