(20 days)
The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The NuVasive Archon Anterior Cervical Plate System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, with a nickel-cobalt-chrome-molybdenum (MP35N) lock screw option conforming to ASTM F562.
The information provided describes a medical device, the NuVasive Archon Anterior Cervical Plate System, which is an anterior cervical plating system. The 510(k) summary and associated FDA correspondence confirm its substantial equivalence to existing predicate devices.
Here's an analysis of the provided text with respect to your questions regarding acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in design | The subject device was shown to be substantially equivalent in design to its predicate devices. |
| Substantial equivalence to predicate devices in intended use | The subject device was shown to be substantially equivalent in intended use to its predicate devices. The intended use is for anterior screw fixation of the cervical spine, providing stabilization as an adjunct to cervical fusion for indications such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. |
| Substantial equivalence to predicate devices in material composition | The subject device was shown to be substantially equivalent in material composition to its predicate devices. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, with a nickel-cobalt-chrome-molybdenum (MP35N) lock screw option conforming to ASTM F562. |
| Substantial equivalence to predicate devices in function | The subject device was shown to be substantially equivalent in function to its predicate devices. |
| Substantial equivalence to predicate devices in range of sizes | The subject device was shown to be substantially equivalent in range of sizes to its predicate devices. |
| Meets or exceeds performance of predicate device (mechanical) | The results of static and dynamic compression testing per ASTM F1717 and static torsion testing per ASTM F1717 showed that the subject Archon Anterior Cervical Plate System "meets or exceeds the performance of the predicate device." |
| Safety and effectiveness for intended use | Based on the overall comparison and performance testing, the device was found to be "safe and effective for its intended use." |
- Sample size used for the test set and the data provenance
The document describes nonclinical testing (mechanical testing) rather than clinical studies using patient data. Therefore, questions regarding "test set," "data provenance," and "country of origin" are not directly applicable in the context of clinical data. For the mechanical tests, the "samples" would refer to the physical specimens of the Archon Anterior Cervical Plate System that underwent testing. The exact number of samples tested for each mechanical test (static/dynamic compression, static torsion) is not specified in the provided text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for nonclinical mechanical testing is typically established by the physical testing and measurements according to standardized protocols (e.g., ASTM F1717), not by expert consensus or interpretations of patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the studies were nonclinical mechanical tests, not studies involving human interpretation or adjudication of patient data for establishing ground truth.
- 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 such study was conducted or described. This device is a mechanical implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This device is a mechanical implant, not an algorithm or AI system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the nonclinical mechanical testing was based on the objective measurements derived from standardized mechanical test methods (ASTM F1717). The performance of the test samples was compared directly against the performance of predicate devices under these conditions.
- The sample size for the training set
This question is not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.
- How the ground truth for the training set was established
This question is not applicable. There is no training set involved for this type of mechanical device submission.
Summary of the Study:
The study was a series of nonclinical mechanical tests designed to demonstrate the physical performance and substantial equivalence of the NuVasive Archon Anterior Cervical Plate System to predicate devices.
Tests Performed:
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
Purpose of the Study:
To demonstrate that the subject device "meets or exceeds the performance of the predicate device" under these mechanical loads, thereby supporting the claim of substantial equivalence in its technological characteristics, function, and safety for its intended use.
Conclusion:
Based on these tests, the device was found to be "substantially equivalent" to legally marketed predicate devices and "safe and effective for its intended use."
§ 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.