(38 days)
The Artus™ cervical plate system is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Artus™ is a cervical plate system that provides one- through four-level standard plate designs as well as one- and two-level midline plates. The plates are designed with a blocking mechanism to restrict screw backout. The plating system offers a variety of screw options including self-drilling, self-tapping and self-drilling/self-tapping, all available in either fixed or variable designs and in standard and rescue diameters. The implants are available in a variety of lengths to accommodate the individual anatomic and clinical circumstances of each patient.
The provided document is a 510(k) summary for the Artus™ cervical plate system. This is a medical device for spinal fixation and not an AI/ML powered device. Therefore, the questions related to AI/ML device acceptance criteria, study details, ground truth, expert involvement, and training/test sets are not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.
1. A table of acceptance criteria and the reported device performance
The document states that mechanical testing of the worst-case Artus™ construct was performed according to ASTM F1717, which includes dynamic compression bending. The acceptance criteria for such tests are generally defined by the FDA and industry standards to ensure the device can withstand physiological loads without failure. While the specific numerical acceptance criteria are not explicitly stated in this summary, the crucial statement is:
"The test results demonstrate that Artus™ device mechanical performance is substantially equivalent to the predicate devices."
This implies that the Artus™ device met or exceeded the performance of the predicate device (uNion™ Cervical Plate System) under the specified ASTM F1717 test, which serves as the de facto acceptance criterion for performance equivalence in this context.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This question is not applicable as the device is a physical implant, not an AI/ML software. The "test set" here refers to physical components for mechanical testing, not data.
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 question is not applicable as this is a physical medical device. "Ground truth" in this context would refer to the established engineering standards and performance of the predicate device. Mechanical engineers and quality control experts would be involved in designing and conducting the tests, but not in establishing an "AI ground truth."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable for a physical medical device.
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 question is not applicable as the device is a physical implant, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical implant, not an AI/ML powered device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a physical medical device like the Artus™ cervical plate system, the "ground truth" for performance is established through:
- Established engineering standards: Specifically, ASTM F1717 for spinal implant devices. These standards define the methods and expected performance characteristics for simulating physiological loads.
- Performance of the legally marketed predicate device: The Artus™ system's performance is compared to the uNion™ Cervical Plate System (K150666). The predicate's successful history and FDA clearance serve as the benchmark for "ground truth" for substantial equivalence.
8. The sample size for the training set
This question is not applicable as the device is a physical implant and does not involve AI/ML training data.
9. How the ground truth for the training set was established
This question is not applicable as the device is a physical implant and does not involve AI/ML training data.
§ 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.