(157 days)
The CoRoent® Small Interlock™ System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy Sevious markers and washers, and three (3) titanium alloy bone fixation screws. The de roos alloy conforming to ASTM F136. The implants are available in a variety of sizes The CoRoent Small Interlock System is a to accommodate anatomical conditions. standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplementary fixation systems.
The NuVasive® CoRoent® Small Interlock™ System is an intervertebral body fusion device. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Performance Data" section of the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Standard) | Device Performance (Results) |
|---|---|
| Static and dynamic torsion (ASTM F2077) | Meets or exceeds the performance of the predicate device. |
| Static and dynamic compression (ASTM F2077) | Meets or exceeds the performance of the predicate device. |
| Subsidence (ASTM F2267) | Meets or exceeds the performance of the predicate device. |
| Wear Debris (ASTM F2077 & ASTM F1877) | Meets or exceeds the performance of the predicate device. |
Based on these results, the device was found to be substantially equivalent to legally marketed predicate devices, indicating it is safe and effective for its intended use.
2. Sample size used for the test set and the data provenance:
The document states that "Nonclinical testing and engineering analysis were performed." However, it does not provide specific sample sizes for each test (e.g., number of implants tested). The data provenance is also not explicitly stated beyond being "nonclinical testing and engineering analysis." It does not specify country of origin or whether the data was retrospective or prospective, as these are typically not applicable to nonclinical engineering bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this submission. The "ground truth" for this device's performance is established through adherence to recognized ASTM standards for mechanical testing, not through expert consensus on medical images or clinical data. The performance is objectively measured against physical and mechanical properties defined by these standards.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where human judgment is involved in establishing a ground truth. For mechanical bench testing, results are quantitative and directly measured against predefined criteria.
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:
This information is not applicable. This document describes a mechanical medical device, an intervertebral body fusion system, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and the concept of "human readers improve with AI" are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a passive implant; it does not involve algorithms or human-in-the-loop performance in the context of an AI system. The term "standalone system" in the device description refers to the fact that it does not require additional supplementary fixation systems when used with the provided bone screws.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "performance data" presented, the "ground truth" is defined by the established parameters and pass/fail criteria within the referenced ASTM international standards (ASTM F2077, ASTM F2267, ASTM F1877). These standards specify the test methods and acceptable performance limits for intervertebral body fusion devices.
8. The sample size for the training set:
This information is not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process are subject to quality control and design verification, but not machine learning training.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
§ 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.