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The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions. The rods come in a variety of diameters and lengths. The plates are available in various widths, lengths and thicknesses. Both the rods and plates have fins to aid in resisting rotation or movement. The rods and plates are made from titanium alloy ((T1-6A1-4V ELI, ASTM F136 or Ti 3Al2.5V, ASTM B348 Grade 9) or CP titanium. The bodies are plasma spray coated with commercially pure titanium

This 510(k) submission (K051309) for the ROI Fusion Rods & Plates does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

Instead, this submission follows the traditional pathway for a medical device by demonstrating substantial equivalence to legally marketed predicate devices. The "study" here refers to nonclinical tests performed to show that the new device is functionally, materially, and in terms of indications similar to existing devices.

Therefore, the requested information elements related to AI/ML device performance (like sample size, experts, adjudication, MRMC studies, standalone performance, and training set details) are not applicable to this document.

Here's an attempt to answer the questions based on the provided text, while highlighting the non-applicability of certain AI/ML-centric questions:

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

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

This information is not applicable as the submission relies on demonstrating substantial equivalence through nonclinical testing (material, functional, and indications comparison), not through clinical trial data or performance testing on a specific "test set" in the context of AI/ML.

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)

This information is not applicable. The "ground truth" for this type of device is established through engineering and material standards, and comparison to existing, legally marketed devices. It does not involve expert image interpretation or diagnostic ground truth.

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

This information is not applicable. Adjudication methods are relevant for clinical studies, especially those involving expert review of diagnostic or prognostic outcomes, which is not the case here.

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

This information is not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretative devices, which the ROI Fusion Rods & Plates are not.

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

This information is not applicable. This device is a bone fixation implant, not an algorithm.

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

The "ground truth" in this context is based on established engineering principles, material standards (e.g., ASTM F136, ASTM B348 Grade 9), and the proven safety and effectiveness of the legally marketed predicate devices. The substantial equivalence argument relies on showing that the new device conforms to these established standards and practices.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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