(126 days)
The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectorny) 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 VBR is also indicated for treating fractures of the thoracic and lumbar spine.
The Atlas Spine VBR 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 VBR can be packed with bone. 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 VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumber vertebral body after complete or partial vertebrectomy.
The device design includes radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.
The provided text is a 510(k) summary for the Atlas Spine Vertebral Body Replacement device, which is a medical implant. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study design for performance evaluation.
Therefore, the document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria as typically expected for a diagnostic AI/ML device or a device requiring new clinical performance data.
The device, the Atlas Spine Vertebral Body Replacement (VBR), is a physical implant, not a diagnostic or AI-driven system. Its clearance is based on substantial equivalence to predicate devices. This means that its safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device that does not require premarket approval (PMA).
Here's a breakdown based on the categories you requested, highlighting why most of the information is not applicable to this type of submission:
-
A table of acceptance criteria and the reported device performance:
- N/A. The submission does not define specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, etc., nor does it report performance in that manner. The "performance" is implicitly deemed equivalent to the predicate devices through design, material, and intended use comparison.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. There is no "test set" in the context of evaluating performance for a new diagnostic algorithm or a device requiring specific clinical performance data. The device's safety and effectiveness are assessed through its substantial equivalence to existing devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No ground truth establishment by experts is described as this is not a diagnostic device and no new clinical performance study requiring such ground truth is mentioned.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as there is no test set or clinical performance study described.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a physical spinal implant, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a physical spinal implant, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No ground truth is established or used in this submission beyond the demonstration that the device's design, materials, and intended use are substantially equivalent to a predicate device.
-
The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no training set mentioned or applicable.
-
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set.
In summary, the provided 510(k) summary for the Atlas Spine Vertebral Body Replacement device focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than presenting a performance study with acceptance criteria, test sets, or ground truth as would be relevant for a diagnostic or AI-driven medical device undergoing a different type of review.
§ 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.