(187 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. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 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) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) idiopathic thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele, k) neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
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.
This K081380 document describes the Cayman Thoracolumbar Plate System, a spinal fixation system. However, it does not include a study proving device performance against acceptance criteria in the way one might expect for a diagnostic AI device. This is a 510(k) premarket notification for a medical device (implantable hardware), not a software algorithm or AI.
The "study" referenced here is largely a mechanical testing study to demonstrate substantial equivalence to existing devices.
Here's the information based on the provided text, and where certain requested sections are not applicable to this type of submission:
Cayman Thoracolumbar Plate System Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What they aimed to demonstrate) | Reported Device Performance (How it met the criteria) |
|---|---|
| Mechanical integrity in static compression bending (in accordance with ASTM F17) | Tested successfully in static compression bending per ASTM F17 |
| Mechanical integrity in dynamic compression testing (in accordance with ASTM F17) | Tested successfully in dynamic compression testing per ASTM F17 |
| Mechanical integrity in static torsion (in accordance with ASTM F17) | Tested successfully in static torsion per ASTM F17 |
| Substantial equivalence in design, material, and indications for use to legally marketed predicate devices | Found to be similar in design, material, and indications for use, and expected to be equivalent in safety and effectiveness to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of number of physical devices tested; however, standardized mechanical tests (like ASTM F17) typically involve multiple samples to ensure statistical validity. The document indicates the type of tests performed rather than the exact number of units.
- Data Provenance: Not applicable in the context of clinical data for a diagnostic device. The "data" here refers to mechanical test results, which would originate from laboratory testing of the manufactured plates and screws.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context would be related to the mechanical properties and performance of the materials and design, which are established by engineering standards and measurements, not clinical expert consensus.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used for interpreting clinical data or images, not for evaluating mechanical testing results.
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 spinal implant device, not an AI or diagnostic imaging system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a spinal implant device, not an AI or algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by engineering standards and mechanical testing specifications (specifically ASTM F17). The performance is compared against the known mechanical properties required for such implants and the performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a mechanical medical device submission like this.
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.