(27 days)
The Trabecular Metal Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
The Trabecular Metal Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.
The provided 510(k) summary for the Trabecular Metal Vertebral Body Replacement System focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and biocompatibility. It does not describe a study involving acceptance criteria for device performance based on diagnostic accuracy or clinical outcomes, as would be the case for AI/ML-enabled devices.
Therefore, many of the requested fields are not applicable to this submission.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a vertebral body replacement system, the "performance" here refers to mechanical and biocompatibility data, not diagnostic accuracy. The acceptance criteria would likely be specified in the cited standards and in comparison to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Expulsion | Performed as intended; equivalent to predicate devices. |
| Static Compression | Performed as intended; equivalent to predicate devices. |
| Dynamic Compression | Performed as intended; equivalent to predicate devices. |
| Static Torsion | Performed as intended; equivalent to predicate devices. |
| Dynamic Torsion | Performed as intended; equivalent to predicate devices. |
| Abrasion | Performed as intended; equivalent to predicate devices. |
| Biocompatibility: | Data provided to support material's use. |
Study that proves the device meets the acceptance criteria:
The submission states, "Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378 and current submission)." It also mentions, "Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicate devices."
The results demonstrated that the device "will perform as intended and is equivalent to the cited predicate devices." This implies that the acceptance criteria for mechanical properties (e.g., maximum deflection, load-bearing capacity, fatigue life as defined by the applicable standards) were met, and the biocompatibility data was deemed acceptable by the FDA.
2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This submission is for a physical implant, not an AI/ML-enabled device or a diagnostic tool that uses a "test set" of patient data. The "test set" would consist of physical devices tested in a lab. The number of devices tested for each mechanical performance criterion is not specified but would be conducted according to relevant ASTM or ISO standards for medical implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth in this context would be objective physical measurements of the device's mechanical properties or biological response in biocompatibility tests, not expert interpretation of images or clinical data.
4. Adjudication method for the test set
N/A. Adjudication methods are typically for resolving discrepancies in expert interpretations of data (e.g., in radiological reads). This is not relevant for mechanical testing or biocompatibility assessment of a physical implant.
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
N/A. This is a physical implant, not an AI-assisted diagnostic or clinical decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical performance, the "ground truth" would be the objective measurements of force, displacement, cycles, wear, etc., obtained through standardized laboratory testing procedures. For biocompatibility, the "ground truth" would be established through laboratory assays and animal studies according to ISO 10993 or equivalent standards.
8. The sample size for the training set
N/A. This is a physical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
N/A. This is a physical implant, not an AI/ML model.
§ 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.