(77 days)
The Atlas Spine Rebar® (Ti) Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Rebar® (Ti) Spacer System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1.
The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Not Found
The provided text is an FDA 510(k) clearance letter for the Atlas Spine Rebar™ (Ti) Spacer System. It outlines the regulatory status and intended use of the device. However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, as it is a clearance letter, not a study report or a summary of performance data.
Therefore, I cannot provide the requested information based on the given input text. The text does not describe any specific performance metrics, test methodologies, sample sizes for a test set or training set, ground truth establishment, expert qualifications, or MRMC studies.
To answer your request, I would need a document such as:
- A clinical study report
- A premarket submission summary (e.g., a 510(k) summary or an IDE report) that details the performance data.
§ 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.