(32 days)
The CAYMAN THORACOLUMBAR PLATES are 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 autograph or allograft in skeletally mature patients in the treatment of 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 Ti6A14V per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the spine.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cayman Thoracolumbar Plate System.
It's important to note that this 510(k) summary is for a medical device (spinal fixation system), not a diagnostic AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable here. Medical device clearances like this typically focus on bench testing and substantial equivalence to previously cleared devices rather than clinical trials with human subjects for performance evaluation in the way an AI/ML algorithm would be.
Acceptance Criteria and Device Performance Study for the Cayman Thoracolumbar Plate System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Standard) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F1717 (Static Compression Bending) | Compliant |
| ASTM F1717 (Dynamic Compression Testing) | Compliant |
| ASTM F1717 (Static Torsion) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test, but standard bench testing typically involves multiple samples to ensure statistical validity for mechanical properties.
- Data Provenance: Not applicable in the context of "data provenance" for patient data, as this is a mechanical device study. The tests were performed in a lab setting according to industry standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a mechanical device, and "ground truth" refers to the results of standardized bench tests, not expert interpretation of patient data. The "experts" would be the engineers and technicians performing the tests and analyzing the results according to ASTM standards.
4. Adjudication Method for the Test Set
- Not Applicable. Mechanical testing to ASTM standards does not involve human adjudication in the way AI/ML diagnostic studies do. Results are based on quantifiable measurements against predefined pass/fail criteria within the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is a mechanical device, not an AI/ML diagnostic tool. Therefore, MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a mechanical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Bench Test Standards: The "ground truth" used for this device's performance evaluation consisted of the mechanical performance criteria established by ASTM F1717 for spinal intervertebral body fixation orthoses.
8. The Sample Size for the Training Set
- Not Applicable. This device is evaluated through physical bench testing, not through training an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See above. There is no training set for an AI/ML model for this type of device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The Cayman Thoracolumbar Plate System was tested in accordance with ASTM F1717, a recognized consensus standard for the mechanical testing of spinal intervertebral body fixation orthoses. The specific tests conducted included:
- Static compression bending
- Dynamic compression testing
- Static torsion
The document states that the devices "were tested in static compression bending, dynamic compression testing and static torsion in accordance with ASTM F1717 and are considered substantially equivalent to other legally marketed devices." This statement implies that the device successfully met the acceptance criteria (performance thresholds) specified within ASTM F1717 for these mechanical properties. The basis for clearance is that the device demonstrates comparable mechanical performance to predicate devices (K081380, K971248, K031100, K062407, K922543) already on the market, sharing similar design, materials, and indications for use. This "substantial equivalence" is the primary mechanism for clearance for this type of medical 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.