(126 days)
The NuVasive CoRoent Small Interlock System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions. The NuVasive CoRoent Small Interlock System is a standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplementary fixation systems.
The provided document is a 510(k) premarket notification for a medical device called the NuVasive CoRoent Small Interlock System. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of submission typically does not include the detailed multi-reader multi-case (MRMC) studies, standalone algorithm performance, or extensive ground truth establishment details that are common for AI/ML-based diagnostic devices. Therefore, much of the requested information regarding AI performance metrics, sample sizes for training/test sets, and expert adjudication methods is not applicable to this document.
However, I can extract the relevant information from the document that pertains to the device's performance and the studies conducted to show its acceptance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Standard) | Reported Device Performance (Summary) |
|---|---|
| Static and dynamic compression per ASTM F2077 | Met or exceeded the performance of the predicate device. |
| Static and dynamic torsion per ASTM F2077 | Met or exceeded the performance of the predicate device. |
| Wear debris/mass change per ASTM F1877 and ASTM F1714 | Met or exceeded the performance of the predicate device. |
| Static push-out per ASTM Work Item Z8423Z | Met or exceeded the performance of the predicate device. |
| Subsidence analysis per ASTM F2267 | Met or exceeded the performance of the predicate device. |
Study Proving Device Meets Acceptance Criteria:
The device's acceptance criteria are based on mechanical and material performance standards relevant to intervertebral body fusion devices. The study conducted to prove the device meets these criteria involved a series of non-clinical, bench-top tests:
- Static and dynamic compression testing per ASTM F2077
- Static and dynamic torsion testing per ASTM F2077
- Wear debris/mass change analysis during ASTM F2077, per ASTM F1877 and ASTM F1714
- Static push-out testing per ASTM Work Item Z8423Z
- Subsidence analysis per ASTM F2267
The results of these studies demonstrated that the NuVasive CoRoent Small Interlock System "meets or exceeds the performance of the predicate device and does not introduce any new risks." This conclusion signifies that the device performs adequately according to the established industry standards for its intended use, by showing substantial equivalence to already legally marketed devices.
Regarding the requested information that is not generally applicable to this type of 510(k) submission for a non-AI/ML device:
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes non-clinical, bench-top mechanical testing, not a clinical study involving human patient data. The "test set" would consist of physical devices and test parameters. The provenance is the testing facility/laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context is established by the specifications of the ASTM standards and the measurements taken during the mechanical tests, not by expert interpretation of clinical data in the same way an AI model's output would be adjudicated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a non-clinical, objective measurement against engineering standards, not a subjective interpretation requiring adjudication among experts.
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:
- Not applicable. This document is for a physical orthopedic implant. It does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the objective measurement results according to the specified ASTM standards (e.g., force applied, displacement, wear quantification).
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/ML system.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.