(86 days)
The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/ 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 Ti-C System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The subject CoRoent Small Ti-C System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. A commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the device. The implant contains a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 serve as radiopaque markers so the location and orientation of the device may be seen radiographically during and after the procedure for position confirmation. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
This document is a 510(k) Premarket Notification from the FDA regarding the NuVasive® CoRoent® Small Ti-C System. It does not describe a study involving an AI/Machine Learning diagnostic device or provide acceptance criteria and performance data in the typical sense for such devices.
Therefore, most of the requested information regarding acceptance criteria, study design, expert qualifications, and AI-related details cannot be extracted from this document.
However, I can provide the non-clinical performance data that was conducted to demonstrate substantial equivalence to predicate devices for this intervertebral body fusion device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static and dynamic axial compression and torsion (per ASTM F2077) | Not explicitly stated in the document, but the implication is that the device must meet established performance limits for intervertebral body fusion devices under static and dynamic loading conditions as defined by the standard. | "The results demonstrate that the subject CoRoent Small Ti-C System presents no new worst-case for performance testing..." (This implies it met the biomechanical performance metrics for strength and stability as expected for such devices and as demonstrated by predicate devices.) |
| Wear debris testing (per ASTM F2077, ASTM F1714 and ASTM F1877) | Not explicitly stated, but implies the device must meet acceptable limits for wear particle generation, which could impact biocompatibility and long-term performance. | "The results demonstrate that the subject CoRoent Small Ti-C System presents no new worst-case for performance testing..." (This implies wear debris generation was within acceptable limits similar to predicate devices.) |
| Bacterial endotoxin testing (BET) (per ANSI/AAMI ST-72:2011) | Not explicitly stated, but the device must meet specified endotoxin limits to ensure it is safe for implantation and meets sterility requirements. | "...and meets the requirements as outlined in the Agency's guidance, 'Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile'." (This indicates passing results for endotoxin levels, confirming sterility aspects.) |
2. Sample size used for the test set and the data provenance
This document discusses non-clinical (mechanical and biological) testing for a physical implantable device. The concept of a "test set" and "data provenance" in the context of clinical data or AI models is not applicable here. The testing was laboratory-based, not patient-data-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical implant, not an AI diagnostic tool that requires ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as above.
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 is not an AI device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the limits defined by the ASTM and ANSI/AAMI standards for biomechanical and biocompatibility performance.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained.
§ 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.