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The ROI-A Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor 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-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.

The ROI-A implants are cylinder shaped blocks in a variety of footprints, heights and lordosis angles.

The ROI-A implants feature a closed graft space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. An anchoring plate in two parts is associated to the device to further enhance its stability.

This 510(k) summary for the LDR Spine ROI-A Implant describes a medical device, specifically a spinal intervertebral body fixation orthosis. The document focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device approval in the US.

Based on the provided information, no clinical study involving human readers or AI algorithms for diagnostic purposes was conducted or is applicable to this device submission. The acceptance criteria and the "study" proving the device meets them are entirely based on non-clinical mechanical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used for mechanical testing of the device itself, not a dataset of patient images or clinical cases. The specific number of devices tested mechanically is not provided in this summary.
• Data Provenance: Not applicable in the traditional sense of clinical data. The mechanical testing would have been conducted in a laboratory setting by LDR Spine USA, likely in the US (Austin, TX, is the company's address). This is a non-clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. Ground truth in the context of diagnostic AI or human reader studies does not apply here. The "ground truth" for mechanical testing would be established by engineering standards and validated testing methodologies.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1) are for resolving discrepancies in expert interpretations of clinical data, which is not relevant to mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, often in conjunction with AI. This submission is for a physical implantable device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance Standards: The "ground truth" for the mechanical testing of the ROI-A Implant is based on established engineering and biomechanical standards for spinal intervertebral body fixation orthoses. The goal was to prove substantial equivalence to the predicate device, implying that its mechanical properties (e.g., strength, durability, stability) are comparable to an already approved device.

8. The Sample Size for the Training Set

• Not applicable. There is no training set mentioned in the context of this device because it is not an AI/ML algorithm or a diagnostic device that requires training on a dataset.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set was used.

Summary of Device Acceptance:

The LDR Spine ROI-A Implant was accepted for market based on the demonstration of substantial equivalence to existing predicate devices (LDR Spine ROI System K043349 and LDR Spine MC+ System K043479). This equivalence was primarily proven through non-clinical mechanical testing. The 510(k) summary explicitly states: "Mechanical test results demonstrate that the proposed ROI-A Implant is substantially equivalent to the predicate device." The FDA's letter confirms this finding of substantial equivalence, allowing the device to proceed to market. There is no mention of clinical trials, human subject data, or AI performance studies in this submission.

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