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The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System 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.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX and Profile).

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The Surgical Titanium Mesh™ System is a medical device and thus does not include AI/ML components for which a test set would be used to establish device performance. The performance data section of the provided text indicates that:

• Biomechanical testing, including static axial compression and dynamic axial compression, were conducted.

Without additional information on acceptance criteria and the specific results of these biomechanical tests, it's not possible to populate the full table or answer all the detailed questions provided in the request. The 510(k) summary focuses on the device's intended use, materials, and substantial equivalence to predicate devices, rather than detailed performance metrics that would be associated with AI/ML diagnostic or predictive tools.

However, I can provide a general structure based on the available information and explicitly state what is missing:

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. The "test set" in this context refers to physical prototypes or samples of the device undergoing biomechanical testing, not a dataset for an AI/ML model. The specific number of physical test samples used for static and dynamic axial compression is not stated in the provided text.
• Data Provenance: Not applicable in the traditional sense of clinical data. The tests were biomechanical in nature, likely performed in a lab setting rather than involving human subjects or clinical data in the context of an AI/ML model.

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. As this is a medical device (implant) and not an AI/ML diagnostic tool, external human experts are not typically used to establish "ground truth" for biomechanical tests in the same way they would be for image interpretation or disease diagnosis. The "ground truth" for biomechanical performance is derived from physical measurements and engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data (e.g., for AI/ML performance evaluation) by resolving disagreements among human readers. Biomechanical testing relies on objective physical measurements and engineering analysis.

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 device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical surgical implant, not an algorithm or software. Its performance is inherent in its physical and mechanical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For biomechanical testing, the "ground truth" is established by engineering standards and physical measurements. For example, the load at which a device fails or deforms beyond a specified limit is an objective physical measurement, not an expert consensus or pathology report.

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. There is no training set for a physical surgical implant.

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