(113 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., 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 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. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The Atlas Spine VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumbar vertebral body after complete or partial vertebrectomy.
The device design includes four radiopaque markers, two on the superior surface and two on the inferior surface, in opposing corners, that allow postoperative radiographic confirmation of the device position and orientation.
This 510(k) premarket notification for the Atlas Spine Vertebral Body Replacement (VBR) does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical devices that are similar in design, materials, and intended use to products already on the market.
Therefore, many of the requested categories (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
Here's a breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI algorithm. The primary "acceptance criterion" for this 510(k) was that the device demonstrates substantial equivalence to predicate devices, meaning it has similar intended use, design, materials, and functional characteristics.
The "reported device performance" is framed in terms of its similarity to predicates:
| Criterion for Substantial Equivalence | Reported Device Characteristics (Atlas Spine VBR) |
|---|---|
| Intended Use | Same as predicate devices (thoracolumbar spine, replacement of diseased vertebral body due to tumors or fractures, restore height, restore biomechanical integrity, used with supplemental fixation, used with bone graft). |
| Design Principles | Substantially the same as predicate devices (rectangular, radiolucent VBR with radiopaque markers). |
| Materials | Made from implantable PEEK (polyetheretherketone) polymer, same as predicate devices. |
| Functional Characteristics | Substantially the same as predicate devices (height, width, length, lordotic angle are within ranges of predicate devices; provides support after resection/removal; functionally complemented by supplemental internal fixation). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission did not involve a "test set" of data for performance evaluation in the context of an AI algorithm. Substantial equivalence is determined through a comparison of the device's characteristics to those of predicate devices.
3. 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)
Not applicable. No "ground truth" was established by experts in the context of a dataset for performance evaluation. The FDA reviewed the company's detailed comparison of its device to predicates to determine substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" or adjudication method was used for performance evaluation.
5. 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
Not applicable. This is a physical implantable device, not an AI/software device. There were no "human readers" interpreting data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implantable device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this type of submission is essentially the legally marketed predicate devices and their known characteristics, safety, and effectiveness. The FDA's determination of substantial equivalence relies on comparing the new device's features, materials, and intended use against these established predicates.
8. The sample size for the training set
Not applicable. This is a physical implantable device; it does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.