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The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. 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 pattern of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchors available for use with the ROI-C system.

This document is a 510(k) summary for the LDR Spine ROI-C Partial Vertebral Body Replacement System. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics are provided in this 510(k) summary. The document states that "Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device system." This implies that the device likely met certain performance criteria to demonstrate substantial equivalence, but those criteria are not detailed (e.g., strength, fatigue life, biocompatibility, etc.).

2. 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 is a 510(k) summary for a spinal implant, which relies on non-clinical performance data to demonstrate substantial equivalence, not clinical study data with human subjects or image data for algorithm evaluation. Therefore, there is no "test set" in the context of clinical or imaging data. The non-clinical analysis and verification activities would involve laboratory testing of the device itself.

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 noted above, this is for a physical medical device (vertebral body replacement system) and relies on non-clinical performance data, not a diagnostic or imaging algorithm that requires expert-established ground truth.

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

Not applicable.

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 physical implant, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical implant.

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

Not applicable. The ground truth for a physical medical implant like this would be established through engineering specifications, material properties, biomechanical testing standards, and conformity to design requirements, rather than expert consensus on clinical or imaging data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states:
"8. Non-Clinical Performance Data
Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device system."

This indicates that the study to prove the device met acceptance criteria was a non-clinical analysis and verification activities. These typically involve:

• Mechanical Testing: Such as compression, fatigue, subsidence, and expulsion testing to ensure the device can withstand the physiological loads it will experience in the spine.
• Material Characterization: Testing the PEEK material for its mechanical properties, biocompatibility, and chemical stability.
• Design Verification: Confirming that the device dimensions, features (like the teeth for stability, closed graft space), and material composition meet the design specifications.
• Compatibility Testing: Ensuring compatibility with the associated titanium anchors.

The "predicate device" is the LDR Spine MC+ Partial Vertebral Body Replacement System (K043479). The goal of the non-clinical testing was to demonstrate that the ROI-C system performs similarly to the predicate device regarding safety and effectiveness for its intended use. The specific test results and acceptance criteria (e.g., "must withstand X N of force for Y cycles without failure") are not detailed in this summary.

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