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ROCC Console is intended for remote scanning, support, review, monitoring and standardization of imaging protocols of medical imaging devices. It is a multi-vendor solution allowing view-only or full access control to connected devices. ROCC Console is also intended for training of medical personnel working on connected medical imaging devices.

ROCC Console is a software device, which is part of the ROCC (Radiology Operations Command Center) system, a cloud-based solution which can connect expert radiology users located at a remote command center with onsite technologists operating an MR/CT scanner on-demand, while enabling real-time operational support/guidance for the scanner console. This ROCC system allows healthcare professionals to share expertise, even when they are not physically present in the same location. Expert users are working from remote office locations within a healthcare facility or from a home office.

ROCC Console is a multiple function device product. The medical device functions include the ability to console of a connected MR/CT scanner from a remote location, and a Protocol Management mode, which can be used to manage updates / harmonize scan protocols across connected MR/CT scanners.

ROCC Console is vendor neutral. It is intended to be used in healthcare environments including imaging modalities (MR or CT) with digital output (DP, DVI, and HDMI) which are either fixed to one location or are in mobile (truck) environments where medical imaging services are provided.

ROCC Console supports three connection methods to exchange the KVM (Keyboard, Video and Mouse) information between the expert user and the technologist. The proprietary software KVM connection includes two applications: a "Console Transmitter App" for use by the technologist on the scanner side, and a "Console Receiver App" for use by the remotely located expert user. The Console Transmitter App is a native Windows application installed on a desktop system, which sends the console video stream over the internet to the Console Receiver App. The Console Receiver App is a web-application that can run on a web browser, and receives and displays the video stream to the remotely located expert user edits the scanner console through mouse and keyboard entries, it sends these keyboard and mouse entries back to the Console Transmitter App, which subsequently sends the scanner console. Additionally, ROCC Console supports off-the-shelf HW/SW KVM switch or VNC. ROCC Console can be used with 3 MR/CT console connections concurrently.

When a patient is to be scanned, the on-site technologist must remain present at all times and retains full control over the MR/CT scanner console and can terminate the editing authorization at any time. For CT connections, full access is limited to what is available in the software associated with the modality workspace and is not applicable to physical switches controlling the radiation exposure.

The Protocol Management mode allows access to the MR/CT scanner console without a technologist on site. It is only intended for protocol management and harmonization and not for any remote imaging support.

The ROCC Console is a Medical Image Management and Processing System (MIMPS) that allows remote scanning, support, review, monitoring, and standardization of imaging protocols for medical imaging devices (MR/CT scanners). It is a multi-vendor solution and can be used for training.

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

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

The provided document does not explicitly list specific numerical acceptance criteria for performance metrics like latency, accuracy, or specific functionality tests, alongside their reported performance. Instead, it states broadly that:

• "All pre-specified performance metrics have been met as demonstrated within the software verification and validation."
• "V&V activities were performed on the proposed ROCC Console and demonstrated that the predetermined acceptance criteria were successfully met and no different questions in terms of safety and effectiveness were raised."
• "The ROCC Console performs as intended."

However, it does mention one specific performance characteristic and its relation to the predicate device:

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

The document does not provide details on the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It refers to "software verification and validation documents" as the source of this information, which are not included in this extract.

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)

The document does not specify the number of experts used and their qualifications for establishing ground truth in the test set.

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

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

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in this context. The ROCC Console is a system for remote control and management of imaging devices, not an AI-powered diagnostic tool directly assisting human readers in interpreting medical images. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not directly apply here. The claim of substantial equivalence is based on non-clinical performance testing.

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

The ROCC Console is a software device that facilitates remote control and management of medical imaging devices, with a human technologist present on-site during scanning in most cases (except for Protocol Management mode). Its primary function involves human operators. The document does not describe a "standalone" or "algorithm only" performance study in the traditional sense of an AI model providing automated results. Performance testing would likely focus on the reliability, responsiveness, and accuracy of the remote control and data transmission functionalities.

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

The document does not specify the type of ground truth used. Given the nature of the device (remote control and management), ground truth would likely relate to the accurate transmission of KVM information, successful execution of remote commands, consistency of protocol management, and overall system functionality without compromising image acquisition or patient safety. This would likely be assessed through functional testing and comparison against expected system behavior.

8. The sample size for the training set

The document does not provide information regarding a training set sample size. The ROCC Console is described as a "software device" and does not explicitly mention the use of machine learning or deep learning algorithms that typically require a distinct training set. The term "training set" is usually applied to AI/ML product validation, which doesn't seem to be the primary validation approach for this device's stated functions.

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

As there is no mention of a training set or the use of AI/ML, the document does not describe how ground truth for a training set was established.

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