(38 days)
The Lanx VBR System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to LS) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial 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 Lanx VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
Implants: The Lanx VBR implants consists of a series of flat, trapezoidal, rectangular and curved shaped The device is offered in different size/configurations to better approximate the anatomical implants. variation observed in different vertebral levels and/or patient anatomy. The devices are manufactured with a hollowed out central area to accommodate bone graft material. The upper and lower surfaces are manufactured in such a way that a series of transverse slots or grooves are formed to improve stability and fixation once the device is inserted.
Materials: all implants are made from implant grade PEEK with titanium position markers, Instruments: The instruments are made from instrument grade stainlens steel.
The provided 510(k) summary describes a spinal intervertebral body fixation orthosis (Lanx VBR) and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/Software as a Medical Device (SaMD) submission.
This document is a 510(k) Premarket Notification for a physical medical device (a spinal implant made of PEEK with titanium markers), not a software device or AI algorithm. Therefore, the questions related to AI/MRMC studies, ground truth, training sets, and sample sizes for test sets in the context of AI/SaMD are not applicable to the information provided.
The "Testing Summary" section is the only part that mentions device performance.
Here's an analysis based on the provided text, highlighting the absence of information relevant to AI/SaMD acceptance criteria and studies:
Acceptance Criteria and Device Performance (as described for this physical device)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Testing | "Fatigue and static testing is complete." |
| "Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device." | |
| Static Testing | "Fatigue and static testing is complete." |
| "Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device." | |
| Biocompatibility | "Additionally, a device material Master File (MAF) recorded with the FDA provided additional biocompatibility information." |
| Material Composition | Not explicitly stated as a pass/fail criterion, but the device is made from implant grade PEEK with titanium position markers. Equivalence to predicates is mentioned based on material composition. |
| Surgical Technique | Not explicitly stated as a pass/fail criterion, but equivalence to predicates is mentioned based on surgical technique. |
| Intended Use | Not explicitly stated as a pass/fail criterion, but equivalence to predicates is mentioned based on intended use. |
Regarding the specific questions which are geared towards AI/SaMD:
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A table of acceptance criteria and the reported device performance: See table above. It describes general testing results for a physical device, not typically quantitative metrics for AI.
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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 information is for AI/SaMD. The document refers to "samples" for fatigue and static testing, which would be physical implant units, not data sets. No specific sample size for these physical tests is provided, nor is data provenance relevant.
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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. This information is for AI/SaMD. Ground truth in this context would typically refer to clinical diagnoses or annotations for an AI algorithm. For a physical implant, "ground truth" might refer to engineering standards or clinical outcomes observed during physical testing, but no specific expert involvement for this is detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This information is for AI/SaMD.
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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 implant, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implant, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical device, the "ground truth" for the
fatigue and static testingwould beaccepted engineering and scientific principlesandcomparison to predicate device performance. Forbiocompatibility, it would be data from adevice material Master File (MAF)recorded with the FDA. No clinical ground truth (expert consensus, pathology, outcomes data) as understood in an AI/SaMD context is mentioned.
- For the physical device, the "ground truth" for the
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The sample size for the training set:
- Not applicable. This is for AI/SaMD.
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How the ground truth for the training set was established:
- Not applicable. This is for AI/SaMD.
Conclusion:
The provided 510(k) summary is for a traditional, physical medical device (spinal implant). It establishes substantial equivalence based on design, material composition, surgical technique, intended use, and fatigue/static testing outcomes that are equivalent to comparison devices. It also references a Material Master File for biocompatibility.
The document does not contain any information pertaining to the development or validation of an Artificial Intelligence (AI) or Software as a Medical Device (SaMD) product. Therefore, the specific questions regarding AI/SaMD acceptance criteria, test/training sets, ground truth establishment, expert adjudication, or MRMC studies cannot be answered from this text.
§ 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.