(199 days)
COALITION® Spacers (including COALITION AGX™ and COALITION MIS™) 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 nonoperative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant.
The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone 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.
The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. 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 and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant.
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 kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
COALITION® Spacers, COALITION AGX™ Spacers, and COALITION MIS™ Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. These 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 AGX™ Plate is an anterior cervical fixation device that is available in various lengths and widths to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implants into adjacent vertebral bodies for bony fixation. The COALITION MIS™ Spacer may also be used with anchors inserted through the anterior titanium portion of the implant into adjacent vertebral bodies.
COALITION® and COALITION MIS™ Spacers are manufactured from radiolucent PEEK polymer and titanium alloy, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. COALITION AGX™ Spacers are manufactured from radiolucent PEEK polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. F136. F1295, and F560. COALITION AGX Plates are made from titanium alloy, as specified in ASTM F136, F1295, and F1472. The COALITION MIS™ Spacer is additionally available in an all-titanium alloy version. The screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
I am sorry, but the provided text describes a medical device (COALITION® Spacers, an interbody fusion device) and its indications for use, along with the regulatory review and basis for substantial equivalence to other devices. This document is an FDA 510(k) clearance letter and summary.
The request asks for:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts for ground truth, adjudication method, and MRMC study details for a test set.
- Standalone algorithm performance.
- Type of ground truth.
- Sample size for the training set and how ground truth was established for it.
This document does not contain information about an AI/ML algorithm or a study involving such a device. It describes a physical medical implant (intervertebral body fusion device) and mentions mechanical testing and a cadaveric implantation study to demonstrate substantial equivalence to predicate devices, but not an AI/ML study with acceptance criteria, ground truth, or training/test sets as would be relevant for an AI/ML device.
Therefore, I cannot fulfill the request as the necessary information regarding acceptance criteria, study details, ground truth for an AI device, or training/test set data is not present in the provided text.
§ 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.