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BoneVue is a software tool for 3D visualization of bone micro-architecture using MRI datasets with the possibility of manual or automated measurements of descriptive parameters regarding cortical and trabecular morphology. BoneVue is a workflow tool intended to assist a trained physician in the assessment of high-resolution MRI datasets of bone.

BoneVye evaluates high-resolution MRI datasets containing bone tissue and provides 3D visualization of trabecular structures as well as measurements of descriptive parameters regarding cortical and trabecular morphology.

The following cortical measurements are reported: average cortical inner diameter, average cortical outer diameter, and average cortical thickness.

The following trabecular measurements are reported: average measures of bone volume/total volume, trabecular thickness, trabecular number, and trabecular separation.

The 3D visualization module is used to display a high resolution 3D model of the trabecular bone and its micro-architecture. The 3D visualization helps a trained physician make a qualitative assessment of bone micro-architecture, which may be viewed from different angles. BoneVue allows standard surface rendering views as well as standard maximum intensity projection views.

Additionally, BoneVue offers the display of a standard "bone plug", a surface rendering of a central cylinder of trabecular tissue, as a representative sample of the bone microarchitecture.

This submission for MicroMRI's BoneVue Software v1 provides a limited amount of information regarding its performance testing. Based on the provided text, a comprehensive study description is not available.

Here's an analysis of what can be extracted and the information that is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document does not specify what the actual quantitative or qualitative acceptance criteria were, nor does it provide any specific numerical or categorical results for the device's performance against these criteria. It only states that the criteria were met.

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

Missing Information: The document does not state the sample size used for the test set or the provenance (country of origin, retrospective/prospective) of the data used in performance testing.

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

Missing Information: The document does not mention the number of experts, their qualifications, or how ground truth was established for the test set.

4. Adjudication Method for the Test Set:

Missing Information: The document does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Missing Information: The document does not mention whether an MRMC comparative effectiveness study was conducted, nor does it provide any effect size for human readers with or without AI assistance. The device is described as a "workflow tool intended to assist a trained physician," implying human-in-the-loop, but no comparative study is detailed.

6. Standalone (Algorithm Only) Performance Study:

Missing Information: The document does not detail a standalone performance study. The description focuses on its function as a tool to assist trained physicians, rather than as an independent diagnostic algorithm.

7. Type of Ground Truth Used for the Test Set:

Missing Information: The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set:

Missing Information: The document does not provide any information about a training set or its sample size.

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

Missing Information: As no training set is mentioned, there is also no information on how its ground truth might have been established.

Summary of what is known from the provided text:

• Device: BoneVue Software v1, developed by MicroMRI, Inc.
• Purpose: 3D visualization of bone micro-architecture from MRI datasets and measurements of cortical and trabecular morphology.
• Indication for Use: A workflow tool to assist a trained physician in assessing high-resolution MRI datasets of bone.
• Performance Claim: "BoneVue has been successfully tested and has met acceptance criteria previously established in accordance with documented procedures." (This is a general statement of compliance, not a detailed report of the study itself.)

Crucially, the provided 510(k) summary does not contain the detailed study that proves the device meets specific acceptance criteria. It only states that such testing was performed and successful. Regulatory submissions often summarize performance testing rather than including the full study report.

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