(104 days)
The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the inplanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
The CAPRI Corpectomy Cage System is a hollow tube structure manufactured from Ti6Al4V ELI and Co-Cr-Mo. The cages are available in a variety of footprints, with adjustable heights and lordoses to match the patient's anatomy.
- Function: The system functions as a vertebral body replacement device to used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.
This document is a 510(k) summary for the CAPRI Corpectomy Cage System, a medical device. The information provided outlines the device's characteristics and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than presenting an exhaustive study proving that the device meets specific acceptance criteria via a clinical trial setup.
Therefore, many of the requested categories related to clinical study design (sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of FDA submission.
Here's an analysis of the provided text based on your questions:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the form of specific thresholds (e.g., minimum tensile strength, maximum wear rate) that the device must meet for mechanical performance. Instead, it states that the device was compared to predicate devices and performed equally to or better than these systems.
| Performance Metric | Acceptance Criteria (Not explicitly stated as numerical thresholds) | Reported Device Performance |
|---|---|---|
| Static Compression | Performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Static Torsion | Performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Dynamic Compression | Performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Dynamic Torsion | Performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Design, Function, Material, Intended Use | Substantially equivalent to predicate devices with no adverse affect | No significant differences that would adversely affect use; substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance evaluation through mechanical testing, not a clinical study involving human or animal subjects. Therefore, the concept of "sample size for the test set" in a clinical sense, or data provenance (country of origin, retrospective/prospective clinical data), is not applicable here. Mechanical testing typically involves a specific number of device samples manufactured to specification. The document does not provide the exact number of devices tested for each mechanical evaluation.
Data provenance: Mechanical testing is typically conducted in a laboratory setting, likely in the US where the company is based, but this is not explicitly stated.
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 is a mechanical evaluation of a physical device, not a study requiring expert clinical review to establish ground truth. "Ground truth" in this context would refer to the true mechanical properties, which are measured directly by engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept relates to disagreement resolution in expert reviews for clinical or imaging studies, which is not relevant to mechanical testing.
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 mechanical device evaluation, not an AI-assisted diagnostic or clinical assessment study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance evaluation is the direct measurement of physical properties through standardized engineering tests (ASTM F2077) performed on the device samples. This is considered objective, empirical data.
8. The sample size for the training set
Not applicable. This document describes mechanical testing for a medical device's 510(k) submission, not a machine learning model's development.
9. How the ground truth for the training set was established
Not applicable. This document does not describe the development or training of an algorithm or model.
§ 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.