(81 days)
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous disc 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 nonoperative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is intended for use with the bone screw fixation provided and requires no additional fixation.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is an integrated anterior cervical interbody fusion device used to provide structural stability following discectomy.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System consists of cages additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking cams manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System implants are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
The interbodies are provided sterile packed and are intended for single use only. The bone screws must be steam sterilized prior to use.
There is no information in the provided text regarding acceptance criteria, device performance, specific studies with sample sizes, ground truth establishment, expert involvement, or any aspects related to AI/software performance.
The document is a 510(k) summary for a medical device (RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through mechanical performance testing.
The "Performance Data" section only mentions that mechanical performance was assessed through static and dynamic construct testing in accordance with ASTM standards (F2077-18 and F2267-04). It does not provide any specific acceptance criteria or reported device performance values for these tests.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or details about a training set.
§ 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.