(89 days)
The Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions.
WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Anterior Cervical Plate System consists of multiple sized plates and screws. All components are manufactured from titanium alloy (Ti-6A1-4V) that conform to ASTM F136.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
This device (Anterior Cervical Plate System) is a Class II medical device, and the submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel clinical effectiveness. Therefore, the study details provided will be different from those typically found for AI/software-as-a-medical-device (SaMD) products.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on ASTM F1717-96) | Reported Device Performance |
|---|---|
| Static Compression Testing | Performed |
| Fatigue Compression Testing | Performed |
| Static Torsion Testing | Performed |
Note: The document states that "The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems." However, it explicitly mentions that testing was performed according to ASTM F1717-96. This implies that compliance with the methods and expected outcomes of this standard would serve as the de facto acceptance criteria for the mechanical performance of the device. The summary doesn't provide specific numerical results of these tests, only that they were performed.
Study Details
This 510(k) submission primarily relies on mechanical performance testing and substantial equivalence arguments rather than a clinical study evaluating diagnostic accuracy or reader performance typically seen with AI/SaMD.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the actual physical devices (plates and screws) that underwent mechanical testing. The exact number of units tested is not specified in the summary but would be dictated by the ASTM F1717-96 standard.
- Data Provenance: Not applicable for mechanical testing. The testing would have been conducted in a laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Mechanical testing outcomes (e.g., force at failure, cycles to failure) are objectively measured by testing equipment, not established by human experts. The "ground truth" is determined by physical properties and engineering principles.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, the results are objective measurements from mechanical testing, not subjective human interpretations requiring adjudication.
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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:
- No MRMC clinical study was performed or is mentioned. This device is an implantable medical device (anterior cervical plate system), not an AI/SaMD product that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software. The "standalone performance" is the mechanical performance of the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical testing, the "ground truth" is the physical measurement of material and structural properties under various stress conditions, as defined and measured according to the ASTM F1717-96 standard.
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The sample size for the training set:
- Not applicable. There is no AI/machine learning model involved; therefore, no "training set" in the computational sense. The design and manufacturing process for the device would have been developed based on general engineering principles and material science.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model. For the mechanical device, its design and expected performance are based on established engineering principles, material specifications (titanium alloy (Ti-6A1-4V) conforming to ASTM F136), and prior knowledge of predicate devices.
§ 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.