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The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1-to L5) and is intended for use with supplemental internal fixation. The ROI-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.

The ROI-C Implants are D-shaped blocks in a variety of heights and length x width combinations. The ROI-C implants feature a closed graft space and the inferior and superior surface of the devices have a patter n of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchor plates available for use with the ROI-C system. The purpose of this submission is to obtain clearance for a modified design of the ROI-C implants.

The provided text describes a medical device, the LDR Spine ROI-C Partial Vertebral Body Replacement System, and its clearance through the 510(k) process. However, it does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria.

The relevant section, "8. Non-Clinical Performance Data," states: "Results of the non-clinical analysis and verification activities indicate that the proposed ROI-C system is substantially equivalent to the predicate device system." This suggests that the evaluation primarily involved non-clinical testing (e.g., mechanical, materials testing) to ensure it met pre-defined engineering or performance standards that align with the predicate device. However, the specific acceptance criteria and the detailed results are not presented in this summary.

Therefore, I cannot populate the requested table or answer most of your questions based on the provided text.

Here's what can be inferred:

• Type of Study: Implicitly, a non-clinical performance study was conducted. It was a comparative study against a predicate device.
• Ground Truth: For non-clinical studies of this type, the "ground truth" would typically refer to established engineering standards, material properties, and performance benchmarks derived from the predicate device.

Information Not Found in the Document:

• Table of Acceptance Criteria and Reported Device Performance: Not detailed.
• Sample size for the test set and data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a non-clinical study description.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted, as this is a non-clinical device.
• Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical implant, not an AI algorithm.
• Type of ground truth used: Implied to be engineering standards/predicate device performance for non-clinical aspects.
• Sample size for the training set: Not applicable for a non-clinical device.
• How the ground truth for the training set was established: Not applicable.

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