(82 days)
All COALITION® Spacers are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two bone screws or anchors. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone. All COALITION® TPS coated spacers are indicated for the same use as non-coated PEEK versions.
The COALITION® Spacer and COALITION AGX® Plate and Spacer assembly are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1) and used with two titanium alloy screws which accompany the implant.
The COALITION MIS® Spacer is an integrated interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, COALITION MIS® Spacers are standalone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS® Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation.
COALITION AGX® Spacer is an interbody fusion device intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation, for one or two levels of the cervical spine (C2-T1). When used with the COALITION AGX® Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX® Spacer, with the COALITION AGX® Plate acting as the supplemental fixation.
The COALITION AGX® Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyohosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
COALITION® Spacers (including COALITION MIS® and COALITION AGX®) are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. COALITION® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. The COALITION MIS® Spacer may also be used with anchors inserted through the anterior titanium portion of the implant into adjacent vertebral bodies.
The provided text is a 510(k) summary for the COALITION® family of intervertebral body fusion devices. It outlines the device description, indications for use, and a general statement about performance data. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in your prompt regarding artificial intelligence (AI) device performance.
Here's why the text is insufficient for your request:
- No AI Component: The document describes medical devices for spinal fusion and their mechanical testing. There is no mention of an artificial intelligence component, machine learning algorithm, or any software that processes or interprets data like an AI device would.
- No Acceptance Criteria for AI Performance: Since there's no AI, there are no acceptance criteria related to its performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" here would be for mechanical properties meeting ASTM standards.
- No Study Details for AI: Consequently, there are no details about sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for an AI component.
- Ground Truth for Training Set: Again, this relates to AI/ML, which isn't present in this document.
In summary, the provided document does not describe an AI medical device. Therefore, it cannot provide the information requested in your prompt.
§ 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.