(36 days)
The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L1-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of the spine.
This document describes a 510(k) summary for the Cayman Thoracolumbar Plate System, Additional Sizes. This submission is for additional sizes of an existing device, and for such submissions, the primary focus is often on demonstrating that the new sizes meet the same performance criteria as the previously cleared device. Therefore, the information provided primarily pertains to mechanical testing rather than clinical studies or AI algorithm performance.
Here's an analysis of your questions based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static compression bending (in accordance with ASTM F1717) | Tested |
| Dynamic compression testing (in accordance with ASTM F1717) | Tested |
| Static torsion (in accordance with ASTM F1717) | Tested |
| Substantial equivalence to legally marketed devices | Considered substantially equivalent to other legally marketed devices based on similar design, material, and indications for use. Expected to be equivalent in safety and effectiveness. |
Note: The document states that the plates were "tested" in accordance with ASTM F1717, and are "considered substantially equivalent." It does not provide specific numerical results or predefined acceptance thresholds for these mechanical tests (e.g., a minimum strength or fatigue life). For medical devices like this, the "acceptance criteria" are often implicit in meeting a recognized standard (like ASTM F1717) and demonstrating performance comparable to predicate devices. The "reported device performance" is essentially that the tests were conducted and the device met the criteria for substantial equivalence to predicates.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a mechanical device (spinal plate system), not a diagnostic or AI-driven device. Therefore, a "test set" in the context of clinical data, AI algorithms, or human performance is not applicable here. The "test set" refers to the physical devices (additional sizes of the plates and screws) that underwent mechanical testing. The sample size for these mechanical tests is not specified in this summary.
Data Provenance: Not applicable in the context of clinical data. The "data" are the results of mechanical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is cleared based on mechanical testing and substantial equivalence to predicate devices, not on human expert review of clinical data or image interpretation.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI-assisted diagnostic tool or a device that impacts human reading performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a mechanical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
For this mechanical device, the "ground truth" implicitly refers to objective mechanical engineering standards (ASTM F1717) and comparison to the established performance of predicate devices. The "ground truth" is that the device, when subjected to specified loads and conditions, performs comparably to or within the acceptable limits defined by those standards and predicates.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI algorithm or clinical study for this mechanical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" or corresponding ground truth establishment process for this mechanical 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.