Search Results

roclub TeleOperationPlatform (rTOP) is a system (software application and hardware component) intended for remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical personnel working on the medical imaging devices. Other medical devices, especially therapeutic devices (e.g. radiotherapeutic devices, ...) with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device) may be used read only.

rTOP is not indicated for any specific disease, or condition.

rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).

roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices. rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location. rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard.

The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times.

The full-control accessibility to higher risk modalities with physical switches ( CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation.

In addition to enabling remote access and control of the modality scanners, rTOP also supports common communication methods including live videos, audio calls and text chats amonq users.

rTOP allows full control of the connected devices, but for higher risk devices (e.g. LINACS, ...) rTOP only provides read-only access.

The provided document is a 510(k) summary for the rTOP device, which is a medical image management and processing system. The summary describes the device, its intended use, and a comparison to a predicate device (syngo Virtual Cockpit).

This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed "acceptance criteria" for performance metrics in the way one might find for a diagnostic AI algorithm. Instead, the acceptance criteria are implicitly met by demonstrating that the rTOP device performs comparably to the predicate device and that any differences do not raise new questions of safety or effectiveness.

Therefore, the response below will present the information based on the available content, highlighting that specific quantitative "acceptance criteria" and a "study that proves the device meets (these) acceptance criteria" in terms of explicit performance metrics are not provided in this 510(k) summary. The document focuses on demonstrating comparable functionality and safety during remote operation.

Here's the information extracted from the provided text:

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

As explicitly stated in the document, no specific quantitative acceptance criteria or corresponding reported device performance metrics were necessary to claim substantial equivalence in the context of this 510(k) submission. The submission focuses on demonstrating that the rTOP device performs "comparably to the predicate device in terms of safety and effectiveness" and that "any differences do not raise new questions of safety or effectiveness."

The closest aspect to performance comparison is related to delay/latency and functionality.

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 explicitly state a sample size for a "test set" in the context of traditional clinical performance or diagnostic accuracy. The testing mentioned refers to "Software verification and validation testing," "bench testing," and "usability testing," which are typically internal development and validation activities.

• No specific sample size for a test set is reported.
• No details on data provenance (country of origin, retrospective/prospective) are provided for any testing mentioned.

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 concept of "ground truth" and "experts establishing ground truth" is typically associated with diagnostic performance studies, especially for AI/ML devices. Since this submission is for a medical image management and processing system for remote operation and does not involve AI for diagnosis, there is no mention of experts establishing ground truth for a test set.

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

Similarly to point 3, as there isn't a diagnostic performance "test set" with ground truth established by experts, an adjudication method for such a test set is not applicable and not mentioned in the document.

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

• No, an MRMC comparative effectiveness study was not done.
• The device (rTOP) is a teleoperation platform for remote operation/assistance; it is not an AI assistance tool for human readers in the context of improving diagnostic accuracy. Therefore, the effect size of human readers improving with AI assistance is not relevant to this device and not reported.

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

• Not applicable in the context of diagnostic performance. The rTOP device's primary function is to facilitate human-in-the-loop remote operation, assistance, and training of medical devices. It is not an algorithm designed for standalone diagnostic or analytical tasks.

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

As mentioned, the device is not for diagnostic purposes, and therefore, the concept of "ground truth" in the context of diagnostic accuracy (e.g., expert consensus, pathology, outcomes data) does not apply. The validation focuses on functional performance, safety, and effectiveness of the remote operation capabilities.

8. The sample size for the training set

The document makes no mention of a "training set" or a sample size for one. This is consistent with the device not being an AI/ML algorithm that requires training data.

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

As there is no mention of a training set, the establishment of ground truth for such a set is also not discussed or applicable.

Ask a specific question about this device