(99 days)
The CoRoent® Small Interlock System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to faciliate 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 (polyetheretherkevtone) 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. 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 supplementary fixation systems.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (NuVasive® CoRoent® Small Interlock™ System). It focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical study with detailed acceptance criteria and performance data as you've outlined.
Specifically, the document states: "A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Interlock System was provided as performance data to support the expanded Indications for Use." and "Additionally, Finite Element Analysis and comparative methods were used to demonstrate that the subject CoRoent Small Interlock System is substantially equivalent to CoRoent Small Interlock System (K102547)."
This indicates that new clinical studies with defined acceptance criteria and performance metrics (as typically seen in AI/software device submissions) were not performed for this submission. The "performance data" referred to is a summary of existing literature and engineering analysis, not a de novo study with a test set, ground truth experts, or MRMC studies.
§ 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.