(229 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 the 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. Additionally, the three-hole version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures.
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 provided text describes a 510(k) submission for the "NuVasive Archon Anterior Cervical Plate System." This is a medical device for spinal fixation, and the marketing clearance is based on substantial equivalence to previously cleared predicate devices, rather than a de novo study with specific acceptance criteria that an AI device would typically have (e.g., sensitivity, specificity, AUC).
Therefore, the information requested, such as a table of accuracy data, sample sizes for test/training sets, expert qualifications, and details about MRMC studies or standalone algorithm performance, is not applicable to this type of submission. This document describes a traditional medical device (spinal implant), not an AI/ML-based diagnostic or assistive device.
However, I can extract information related to the device's "performance data" as described in the document, which serves a similar purpose of demonstrating safety and effectiveness based on equivalence.
Here's a breakdown based on the closest applicable information in the text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are not reported as specific performance metrics (like accuracy, sensitivity) against a clinical gold standard. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices in terms of design, intended use, material composition, function, and range of sizes, and showing that the technological characteristics do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Demonstrated through Equivalence) | Reported Device Performance (Demonstrated through Equivalence) |
|---|---|
| Material Composition (Ti-6Al-4V ELI / MP35N) | Conforms to ASTM F136 or ISO 5832-3 (for Ti-6Al-4V ELI) and ASTM F562 (for MP35N lock screw option). Substantially equivalent to predicates. |
| Technological Characteristics | Same technological characteristics as predicate devices. The addition of a wide plate configuration does not present a new worst-case. |
| Mechanical Performance / Biocompatibility | Assessed via Finite Element Analysis (FEA) and comparative methods. Mechanical testing submitted and cleared for the predicate device (K122910) was adopted, as the new configuration was not a worst-case. |
| Intended Use & Indications | Identical or equivalent to predicate devices. Intended for anterior screw fixation of cervical spine, as an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, etc. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This device does not use a "test set" in the context of an AI/ML diagnostic or predictive model. Its safety and effectiveness are demonstrated through engineering analysis (FEA), comparative methods, and literature review against predicate devices.
- Data Provenance:
- Engineering Data: Finite Element Analysis data would be generated in-house.
- Clinical Literature Review: Retrospective, provenance of studies would be global from medical literature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. No "ground truth" was established by experts in the context of a diagnostic test set for this spinal implant. The evaluation relies on engineering principles and regulatory comparison.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device, so an MRMC study is not relevant. The study performed involved engineering analysis and a literature review for comparison to predicates.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This is a physical implant, not an algorithm.
7. Type of Ground Truth Used
- Not applicable in the typical sense of a diagnostic device. The "ground truth" for this submission is effectively established by:
- Predicate Device Performance: The known safe and effective performance of comparable, legally marketed devices.
- Engineering Principles: Finite Element Analysis and mechanical testing data, which demonstrate structural integrity and performance in vitro.
- Clinical Literature: Retrospective review to support the safety and effectiveness of the intended use and similar plate systems.
8. Sample Size for the Training Set
- Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No "training set" for AI/ML was involved.
§ 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.