(29 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 generally rectangular in shape with anterior and posterior walls that are concentric arcs. The device is available in various sizes with an anterior height ranging from 10mm to 18mm and anterior width of 28mm while providing 0 or 5 degrees of lordosis. The posterior aspect is tapered, or bulleted, for ease of insertion. All devices are 20.0mm in length. The device design includes four radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.
This document describes a 510(k) premarket notification for the Atlas Spine Vertebral Body Replacement (VBR) device. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials or detailed performance studies to establish acceptance criteria for novel device performance.
Therefore, many of the requested elements for a study proving device performance (such as acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not typically present or required in a 510(k) submission for a device demonstrating substantial equivalence. The primary "study" is often a comparison of the new device's design, materials, and intended use against a legally marketed predicate device.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. A 510(k) for substantial equivalence usually doesn't specify new, quantifiable acceptance criteria for device performance beyond meeting the characteristics of the predicate device. The "performance" demonstrated is that the device is substantially equivalent to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided because a specific "test set" in the context of a new performance study (e.g., clinical trial) is not described. The submission relies on a comparison to a predicate device.
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):
This information is not provided. Ground truth established by experts is not relevant in this 510(k) context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This information is not provided. An MRMC study is not relevant to this type of device and submission. The device is a physical spinal implant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided. This refers to AI algorithms, which is not applicable here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided.
8. The sample size for the training set:
This information is not provided. Training sets are generally associated with machine learning models, which are not applicable to this physical device submission.
9. How the ground truth for the training set was established:
This information is not provided.
Summary of what is present in the document relevant to how the device meets "acceptance criteria" (understood here as "criteria for substantial equivalence"):
The document argues that the Atlas Spine VBR meets the acceptance criteria for substantial equivalence through a comparison to its predicate device, Atlas Spine Vertebral Body Replacement (K063464).
Here's how the "study" (the 510(k) submission) proves the device meets these criteria:
- Intended Use: The intended use of the Atlas Spine VBR is directly compared and found to be "substantially the same" as the predicate device. Both are for use in the thoracolumbar spine (T1-L5) for partial or complete replacement of a diseased vertebral body (tumors, fractures) to achieve decompression, restore height, and maintain biomechanical integrity. Both are intended to be used with supplemental spinal fixation systems and packed with bone.
- Design: The device's design (generally rectangular, anterior and posterior walls with concentric arcs, various sizes: 10mm-18mm anterior height, 28mm anterior width, 0 or 5 degrees lordosis, 20.0mm length, tapered posterior aspect, four radiopaque markers) is presented and compared against the predicate as being "substantially the same" in design principles.
- Materials: Both the subject device and the predicate devices are made from implantable PEEK (polyetheretherketone) polymer, establishing material equivalence.
- Functional Characteristics: It is stated that the "functional characteristics... are substantially the same." Both systems provide support after resection/removal of a damaged/collapsed/unstable vertebral body and are complemented by supplemental internal fixation.
Conclusion from the document:
The FDA reviewed the 510(k) submission (K071497) and determined that the Atlas Spine Vertebral Body Replacement is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed. This determination implies that the device "meets the acceptance criteria" as defined by the 510(k) process for substantial equivalence.
§ 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.