(87 days)
The RIGEL™ PEEK Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.
The RIGEL™ Interbody Fusion System consist of implants manufactured from medical implant grade VESTAKEEP®i4R PEEK per ASTM F2026-17 with tantalum markers fabricated from medical implant grade ASTM F560-17. The Interbody Fusion Devices are offered in three footprints, various heights, and lordosis to accommodate different patient anatomy and an anterior surgical approach. The implants will be provided non-sterile and are intended for single use only.
This document is a 510(k) premarket notification for the RIGEL™ PEEK Anterior Cervical Interbody Fusion System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and design specifications, rather than AI-driven diagnostic or assistive technology. Therefore, the information requested for AI/software-based device evaluation (e.g., acceptance criteria for AI performance, clinical study details, ground truth establishment, MRMC studies, training/test set details) is not present in this document.
The document discusses:
- Acceptance Criteria: While not explicitly listed as "acceptance criteria" in a table for performance metrics (as might be expected for an AI device), the studies performed (Static and dynamic compression, static and dynamic shear per ASTM F2077-17, and Subsidence testing per ASTM F2267-04) served as the basis for demonstrating equivalence in mechanical performance. The "acceptance criteria" here is implicitly that the device performs mechanically comparably to the predicate devices as per these ASTM standards.
- Device Performance: The document states, "The preclinical testing listed above that was performed on the RIGEL™ PEEK Anterior Cervical Interbody Fusion System indicate that it is substantially equivalent to the predicate devices in mechanical performance." No specific numerical performance values are provided.
Therefore, since the device is a physical interbody fusion system and not a software/AI product, the detailed information about AI-specific acceptance criteria, study methodologies for AI performance, expert adjudication, MRMC studies, and training/test set ground truth (points 1-9 in your request) is not applicable or available in this submission.
§ 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.