(21 days)
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vesses in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
The Cure™ Lumbar Plate System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters. Cure™ Lumbar Plate System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The provided text describes a medical device, the Cure™ Lumbar Plate System, and its 510(k) premarket notification to the FDA. The information focuses on regulatory approval and equivalence to a predicate device, rather than the performance of a software or AI-driven diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/software device performance, is not present in the provided text.
The document states that the Cure™ Lumbar Plate System is substantially equivalent to a predicate device (K022791 Synthes Anterior Tension Band System) based on technological characteristics and non-clinical testing.
Here's a breakdown of the available information based on your request, highlighting what is not applicable or not found:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Mechanical function and properties | Equivalent to predicate device (Synthes Anterior Tension Band System) |
| Bacterial Endotoxin Limits | Passed testing according to ANSI/AAMI ST-72:2011 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as the document describes non-clinical mechanical and biological compatibility testing, not a clinical study on human subjects or an AI diagnostic test set.
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):
This information is not applicable as there is no mention of a "test set" in the context of expert ground truth for a diagnostic device. The evaluation was based on engineering and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is 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:
This information is not applicable. This describes a physical implantable device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable in the context of diagnostic accuracy. For the non-clinical testing, the "ground truth" would be established engineering standards (ASTM F1717) and biological standards (ANSI/AAMI ST-72:2011).
8. The sample size for the training set:
This information is not applicable as there is no AI component or training set described.
9. How the ground truth for the training set was established:
This information is 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.