(55 days)
The Customer Remote Console Software Option allows remote access for viewing/review of images as well as the ability to remotely provide real time guidance to the technologist operating GE Healthcare medical imaging devices. This access must be granted by the technologist operating the system. The remote access is only available for systems supporting GE remote connectivity capability. Images reviewed remotely are not for diagnostic use.
Customer Remote Console (CRC) is a customer facing software application that is fully contained within a hospital provider network. It provides remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the GE Healthcare medical imaging devices in the context of training. procedure assessment, and scanning parameter management. Remote users will be able to log into a GEHC imaging medical device from a device (Laptop/Desktop) which meets minimum required specifications anywhere within the provider network. This allows users to spread imaging knowledge and expertise without limitation of time or distance. This access must be aranted by the technologist operating the system and it can also be revoked at any time by the technologist. While a remote session is taking place, the technologist operating the system will have complete control of the session at all times. Also, each remote session will be controlled via a secure credential that is managed by the technologist operating the system. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use.
This document is a 510(k) summary for the GE Medical Systems, LLC Customer Remote Console (CRC). It outlines the device description, intended use, indications for use, and a comparison to predicate devices, but it does not contain the detailed information needed to answer many of the questions about acceptance criteria and specific study designs.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of reported device performance in the way typically expected for clinical accuracy or efficacy studies. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and assurances of quality control.
From the text, implicit "acceptance criteria" related to functionality and safety are:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Remote access for viewing/review of images | Provides remote access for viewing/review of images. |
| Remotely provide real-time guidance to technologist | Allows the ability to remotely provide real-time guidance to the technologist operating GE Healthcare medical imaging devices (for training, procedure assessment, scanning parameter management). |
| Access granted by technologist | Access must be granted by the technologist operating the system and can be revoked at any time. |
| Technologist has complete control during remote session | While a remote session is taking place, the technologist operating the system will have complete control of the session at all times. |
| Secure credential control | Each remote session will be controlled via a secure credential managed by the technologist. |
| Limited to one remote session at a time | Connections to a medical device are limited to one remote session at a time. |
| Remote access only for systems supporting GE remote connectivity capability | The remote access is only available for systems supporting GE remote connectivity capability. |
| Images reviewed remotely are not for diagnostic use | Images reviewed remotely are not for diagnostic use. |
| Authentication required for remote users | CRC User has to be authenticated before the user can connect to the imaging device. |
| Capability for customer to select display quality during a remote session | CRC provides the capability for the customer to select the display quality during a remote session. |
| Restriction of remote user access to certain icons on the console of the imaging medical device | A remote user does not have access to certain icons on the console of the imaging medical device. |
| Technologist and remote users both have capability to terminate remote session | Both the technologist operating the scanner and the remote users both have the capability to terminate the remote session. |
| Design and manufacturing under Quality System Regulations | The device is designed and manufactured under the Quality System Regulations of 21 CFR 820. Quality assurance measures applied include Risk Analysis, Requirements Reviews, Design Reviews, Performance/Safety testing (Verification), and Clinical Scenarios testing (Validation). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission states, "The subject of this premarket submission, CRC, does not require clinical studies to support substantial equivalence." Therefore, there would not be a specific "test set" in the context of clinical performance evaluation.
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)
This information is not applicable as no clinical studies requiring ground truth establishment were conducted or reported for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies requiring adjudication were conducted or reported.
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
This information is not applicable. The CRC device is a remote access and guidance tool, not an AI-assisted diagnostic or interpretation device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The CRC is inherently a "human-in-the-loop" system, designed to facilitate interaction and guidance between a remote user and a local technologist. It is not an automated algorithm performing a task independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as no clinical studies requiring ground truth establishment were conducted or reported.
8. The sample size for the training set
This information is not provided and is likely not relevant in the context of this device's type. Software development involves testing and validation, but not typically "training sets" in the machine learning sense for a device of this nature.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a training set or ground truth establishment for such a set in this document.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).