(115 days)
Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine Spacer is also indicated for treating fractures of the thoracic and lumbar spine.
The Atlas Spine Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine Spacer can be packed with autograft and/or allograft. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).
The Atlas Spine Spacer is a rectangular, radiolucent device provided in various sizes. The device design includes six radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.
The provided text describes a 510(k) premarket notification for the Atlas Spine Spacer, a medical device. However, it does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria in the way a diagnostic AI device submission would.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices. It states:
- "The Atlas Spine Spacer was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function and material."
- "Pre-clinical data per ASTM F2077 have been submitted to characterize the Atlas Spine Spacer."
This is typical for a 510(k) submission where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific clinical endpoints or diagnostic accuracy metrics with a comprehensive study involving human subjects and ground truth.
Therefore, I cannot provide the requested table and details because the information is not present in the given text. The document indicates pre-clinical data per ASTM F2077 was submitted, which would involve mechanical testing to characterize the device's physical properties, but not performance in a clinical diagnostic sense.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.