(28 days)
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The NuVasive ACP 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. The NuVasive ACP System was initially cleared in K191500. In K191500, static torsion results were included for the predicate NuVasive ACP System. The tested construct varied slightly in design from the cleared device. After clearance, confirmatory ASTM F1717 mechanical testing was completed on the cleared design, which revealed lower results in static torsion. The purpose of this submission is to present the lower static torsion test values of the subject NuVasive ACP System, which remain greater than Helix Mini ACP System (K073275), the cited predicate for static torsion, in K191500. Additionally, minor design changes and a labeling update to the system are presented. The design changes are minor updates to the system since clearance in K191500. Select changes have been implemented via the add to file process. Additional design updates are also being presented, which will be implemented pending review of the subject submission.
This document describes the NuVasive® ACP System, an anterior cervical plating system. It is a medical device intended for anterior screw fixation of the cervical spine (C2-C7) for various indications. The submission (K201078) primarily addresses updated static torsion test values and minor design changes to the system.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (spinal intervertebral body fixation orthosis), not an AI/software device. Therefore, many of the requested elements for AI/software (e.g., ground truth establishment, MRMC studies, training/test set details, expert qualifications for AI output review) are not applicable to this type of submission and are consequently not present in the document.
The "acceptance criteria" and "study" for this device are focused on mechanical performance and substantial equivalence to previously cleared predicate devices, rather than the performance of an AI algorithm in interpreting medical images or generating diagnoses.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating its mechanical performance (specifically static and dynamic testing) and material compatibility, and that these characteristics are substantially equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implied from the text) | Reported Device Performance and Compliance |
|---|---|---|
| Mechanical Performance (Static Torsion) | Must meet or exceed the performance of the predicate device (specifically, the Helix Mini ACP System (K073275), as per K191500, for static torsion). Lower static torsion values were identified for the subject device after initial clearance (K191500) and are now being presented, but they must still be acceptable relative to the predicate. | "confirmatory ASTM F1717 mechanical testing was completed on the cleared design, which revealed lower results in static torsion. The purpose of this submission is to present the lower static torsion test values of the subject NuVasive ACP System, which remain greater than Helix Mini ACP System (K073275), the cited predicate for static torsion, in K191500." |
"The results of these studies show that the subject NuVasive ACP System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device." |
| Mechanical Performance (Static Compression Bending) | Must be demonstrated per ASTM F1717 standards and show substantial equivalence to predicate devices. | "Static torsion, static compression bending, and dynamic compression bending testing per ASTM F1717."
"The results of these studies show that the subject NuVasive ACP System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device." |
| Mechanical Performance (Dynamic Compression Bending) | Must be demonstrated per ASTM F1717 standards and show substantial equivalence to predicate devices. | "Static torsion, static compression bending, and dynamic compression bending testing per ASTM F1717."
"The results of these studies show that the subject NuVasive ACP System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device." |
| Material Composition | Must conform to specified ASTM/ISO standards for biocompatibility and mechanical properties (e.g., Titanium alloy). | "The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3." |
| Substantial Equivalence (Overall) | The device must be shown to be substantially equivalent to predicate devices in areas including design, intended use, material composition, function, and range of sizes, and not introduce new risks. | "As was established in this submission, the subject NuVasive ACP System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes."
"The results of these studies show that the subject NuVasive ACP System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device."
"Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive ACP System has been shown to be substantially equivalent to legally marketed predicate devices." |
| Design Changes Impact | Minor design updates should not create a new worst case in mechanical performance or introduce new risks. | "Finite Elemental Analysis and engineering rationales were used to establish that the minor design updates introduced did not create a new worst case." |
Study Proving Device Meets Acceptance Criteria
The study conducted is a nonclinical performance testing and engineering analysis to demonstrate substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of "samples" in terms of clinical cases or patient data, as this is bench testing. For mechanical testing, usually multiple samples of the actual device components (plates, screws) are tested according to the ASTM standard. The document states "confirmatory ASTM F1717 mechanical testing was completed on the cleared design."
- Data Provenance: This is
- Bench Test Data: Generated from laboratory mechanical testing of the NuVasive ACP System components.
- Retrospective/Prospective: Not applicable in the traditional clinical trial sense. The testing was specifically performed to address a particular finding (lower static torsion results) for a physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This part of the request applies to AI/software performance studies where ground truth is often established by human experts (e.g., radiologists interpreting images). For a spinal implant, "ground truth" is established by adherence to engineering standards (ASTM F1717) and direct physical measurement of mechanical properties. Expertise would be in materials science, biomechanical engineering, and regulatory compliance.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method is described because there is no human interpretation of data requiring consensus. Mechanical testing results are quantitative and objective measurements against defined standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant; therefore, such a study is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Quantitative Mechanical Properties & Engineering Standards: The "ground truth" here is defined by the requirements of the relevant ASTM standards (F1717 for static torsion, static compression bending, and dynamic compression bending) and the mechanical performance of the legally marketed predicate devices. The claim is that the subject device's measured mechanical properties meet or exceed these established benchmarks.
8. The sample size for the training set:
- Not applicable. This refers to training an AI model.
9. How the ground truth for the training set was established:
- Not applicable. This refers to establishing ground truth for AI model training.
§ 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.