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OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (e.g. ROSA® Knee, ROSA® Partial, or ROSA® Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2).

The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities:

• Mixed Reality visualization solution
• Register hand gestures as inputs such as to touch, move and resize views
• Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform

The OptiVu™ ROSA® MxR device is designed to display surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface via a head-mounted display (HMD) like the HoloLens 2. It's important to note that images viewed through the HMD are for informational purposes only and are not intended for diagnostic use.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a typical tabular format. Instead, it describes general performance goals and verification activities. The overall acceptance criterion is demonstrating substantial equivalence to predicate devices without raising new questions of safety and effectiveness.

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

The document does not specify a separate "test set" in the context of a clinical study with patient data. The performance evaluations described are primarily non-clinical device performance testing, engineering analysis, software verification and validation, and usability engineering. Therefore, the concept of sample size for patient data or data provenance (country of origin, retrospective/prospective) is not directly applicable in the information provided.

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

As there is no mention of a clinical test set requiring expert-established ground truth related to patient data or diagnostic interpretations, this information is not provided. The device explicitly states that images viewed through the HMD are "for informational purposes only and are not intended for diagnostic use."

4. Adjudication Method for the Test Set

Given the absence of a clinical test set requiring expert interpretation of patient data, there is no mention of an adjudication method (e.g., 2+1, 3+1). The performance testing described focuses on the device's technical functionality and software integrity.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The device's indications for use emphasize displaying surgical workflow information rather than diagnostic interpretation or AI-driven decision support for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "Software Verification and Validation Testing" and "Device Performance Testing." While these are standalone tests of the algorithm's functional performance, they are not presented as a standalone clinical performance study in the sense of an algorithm making diagnostic or treatment decisions without human oversight. The device is an accessory for surgical workflow information display, not an autonomous diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used

For the software and device performance testing:

• Engineering specifications and design inputs served as the "ground truth" or reference for verification and validation activities. The tests aimed to ensure the device met these predefined requirements.
• Regulatory standards and guidance documents (e.g., FDA Guidance for Content Premarket Submissions for Software, IEC 62304) provided the "ground truth" for software quality and safety.

No "ground truth" in terms of expert consensus, pathology, or outcomes data for clinical decision-making is mentioned, consistent with its informational purpose.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning. The device appears to be primarily an interface and display tool, integrating with existing ROSA® RECON Platform software, rather than a system that learns from a large dataset.

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

As no training set (for machine learning) is discussed, the method for establishing its ground truth is not applicable or provided.

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