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510(k) Data Aggregation
(259 days)
Trabis
Trabis® is a vertebral body replacement system indicated for use in the cervical spine (from C2 to T1 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Trabis® is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. Trabis® is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The devices included in this submission are a subset of the devices that were included in the OstaPek® VBR System, cleared in K072326. The only difference between the Trabis® and the K072326 subset is that the Trabis® VBR are intended for the use in the cervical spine, whereas the devices cleared in K072326 were cleared for use in the thoracolumbar spine. Therefore, the purpose of this 510(k) is to modify the Indications for Use for the subject Trabis®.
The document provided is a 510(k) summary for the Trabis® vertebral body replacement system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical (mechanical) testing and a retrospective clinical study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
Acceptance Criteria and Reported Device Performance
For medical devices, "acceptance criteria" are generally established to demonstrate that the device performs as intended and is safe and effective. In a 510(k) submission, this often means demonstrating substantial equivalence to a legally marketed predicate device. The primary acceptance criteria for the Trabis® device, as inferred from the "Non-clinical Test Summary" and "Conclusions: Non-clinical and Clinical" sections, are related to its mechanical performance and clinical outcomes being comparable to predicate devices.
| Acceptance Criterion (Inferred) | Reported Device Performance (from "Non-clinical Test Summary") |
|---|---|
| Mechanical Equivalence | "Mechanical testing confirmed Trabis® demonstrated equivalent performance to the cited predicate device under the same test conditions." Specific tests included:Static and dynamic compression per ASTM F2077Static and dynamic torsion per ASTM F2077Subsidence per ASTM F2267"The results of these evaluations indicate that Trabis® is equivalent to predicate devices." |
| Clinical Outcomes | "The study analyzing the outcome and radiological findings for anterior cervical corpectomy with the use of carbon composite Trabis®, as a support with space for grafts after cervical corpectomy of one or more levels, performed at three centers. . . . The submitted data indicates that Trabis® is substantially equivalent to the predicate devices with regard to its clinical performance." (This is indirectly inferred, as the document states overall substantial equivalence based on both non-clinical and clinical data, but doesn't explicitly state quantitative clinical acceptance criteria). |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Ninety-three patients were treated with the Trabis® after cervical corpectomy of one or more levels for different reasons." So, N=93 patients.
- Data Provenance: The study was "retrospectively reviewed." It was conducted at "three centers." The country of origin is not explicitly stated in the provided text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used to establish the ground truth or their qualifications. It mentions "analyzing the outcome and radiological findings," which implies some form of assessment, but not who performed it or how consensus was reached.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not provide any information on the adjudication method used for the test set.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical vertebral body replacement system, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth appears to be based on "outcome and radiological findings" from the retrospective review of patient cases. This implies a combination of clinical assessments and imaging interpretations. The specific details of how these "findings" were adjudicated or confirmed (e.g., against pathology, long-term outcomes) are not detailed.
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The sample size for the training set:
- The document describes a retrospective clinical study for performance evaluation, not an AI/algorithm-based device that would typically have a separate "training set." Therefore, no training set sample size is mentioned.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an algorithm.
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