(55 days)
The Nexus Spine Stable-C Interbody 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0,°6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy.
The purpose of this Traditional510(k) submission is to gain clearance for modifications made to the subject device.
This document is a 510(k) premarket notification for a medical device called the "Stable-C Interbody System" by Nexus Spine, LLC. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria, such as:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Instead, the document focuses on:
- Device Description: The Stable-C Interbody System is an anterior cervical interbody device made of titanium alloy, with lordotic angles of 0°, 6°, and 12°. It includes two fixation anchors.
- Indications for Use: Indicated for skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1, defined as discogenic back pain with degeneration confirmed by history and radiographic studies. It is a standalone system to be used with bone anchors and autogenous or allogenic bone graft, after six weeks of non-operative treatment.
- Substantial Equivalence: The primary predicate is Nexus Spine, LLC Stable-C Interbody System (K231763; K232530), with an additional predicate being Nexus Spine, LLC Tranquil-C Interbody System (K240416). The subject device's indications, sizing, geometry, technological characteristics, materials, manufacturing, sterilization, and packaging are stated to be similar or identical to the predicate devices.
- Performance Testing: The submission states that "The subject changes to the Stable-C Interbody System do not introduce a new worst case, as confirmed by bench top usability testing of the device and instrumentation in a simulated implantation. Additional performance testing is not required to establish substantial equivalence." This indicates that no new clinical or significant performance studies were conducted to prove specific acceptance criteria for the current submission beyond bench-top usability testing to confirm the changes did not worsen performance compared to the already cleared predicate device.
In summary, this document is a 510(k) submission and does not describe a study to prove a device meets acceptance criteria in the manner you've requested. It argues for substantial equivalence based on similarities to predicate devices and limited bench testing for modifications.
§ 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.