(55 days)
The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The System is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherketone) 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® LT1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136, and tantalum conforming to ASTM F560. The implants are available in a variety of sizes to accommodate anatomical conditions. The 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 supplemental fixation.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the NuVasive® CoRoent® Small Interlock™ System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the "device meets acceptance criteria" in terms of an AI/ML algorithm's performance.
Therefore, the specific information requested in the prompt regarding acceptance criteria, performance metrics, test set, ground truth, expert adjudication, MRMC studies, and training set details are not applicable to this document. The document describes a physical intervertebral body fusion device, not a software or AI-based diagnostic/screening tool.
Here's a breakdown of why each point is not relevant based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. This device is a physical implant. The "performance data" mentioned (Section G) refers to a clinical study demonstrating safety and effectiveness for a physical device, not an algorithm's performance metrics like sensitivity, specificity, or AUC.
- Sample sized used for the test set and the data provenance: Not applicable. The "clinical study" mentioned is to support the expanded indication for a physical implant, not to test an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, refers to expert-labeled data. Here, the "ground truth" for the device's efficacy would be clinical outcomes in patients.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for resolving disagreements among human labelers of data for AI model training or testing.
- 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. MRMC studies are used to assess the impact of AI tools on human interpretation of medical images. This device is an implant, not an AI tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, ground truth relates to clinical outcomes and safety profiles. The document mentions "clinical data" and "safety and effectiveness profile" but doesn't detail the specific type of ground truth beyond that.
- The sample size for the training set: Not applicable. There is no AI model or training set described.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA document is for a physical medical implant (intervertebral body fusion device), not a software or AI-powered device. Therefore, the questions related to AI/ML model acceptance criteria, performance studies, and ground truth establishment are not addressed in this document.
§ 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.