(84 days)
Digital Expert Access with Remote Scanning is intended as a remote collaboration tool to view and review MR images, to remotely control MR Imaging Devices and to initiate MRI scans remotely.
Digital Expert Access with Remote Scanning is a remote scan assistance solution which allows remote control of an MR Imaging Device including the ability to initiate a scan remotely. This access provides real time communication mechanisms between the remote and onsite users to facilitate the acquisition occurring on the device. Access must be granted by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.
Digital Expert Access is a variation of the Customer Remote Console cleared under K150193. It is a remote scan assistance solution designed to address the skill variability in technologists and their need for ondemand support by allowing them to interact directly with a remote expert connected to the hospital network. By enabling the collaboration between an Onsite Technologist and Remote Expert, Digital Expert Access helps the onsite technologist to seek guidance and real time support on scanning related queries including but not limited to training, procedure assessment, and scanning parameter management.
Digital Expert Access with Remote Scanning introduces a feature that enables the Remote Expert to initiate a scan and make changes in real time during the scanning session. This remote scan feature is only available when Digital Expert Access is connected to a compatible GE HealthCare MRI system.
Digital Expert Access with Remote Scanning enables the following capabilities for the Onsite Technologist and the Remote Expert:
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- Collaborative session between an Onsite Technologist and Remote Expert
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- Real-time scanner screen share and live annotation
- ന് Remote console access and control
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- Remote Scan Initiation
Digital Expert Access with Remote Scanning is not intended for diagnostic use or patient safety-related management. This solution is not intended to be used by individuals who are not properly trained in the operation of GE HealthCare Medical Imaging systems. Digital Expert Access with Remote Scanning does not directly interface with any patients and requires the Onsite Technologist to be continuously present throughout the scanning procedure. Digital Expert Access with Remote Scanning does not acquire any MRI images, nor does it do any post image processing. All image acquisition and image processing is conducted by the GE HealthCare MRI system.
The provided text describes a 510(k) premarket notification for a device called "Digital Expert Access with Remote Scanning." This document outlines the device's purpose, intended use, and substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document emphasizes that the device did not require clinical studies to support substantial equivalence. Instead, the focus was on non-clinical tests, primarily design verification and validation testing, to ensure proper implementation of design requirements and that no new safety or effectiveness issues were introduced.
Therefore, many of the requested details about acceptance criteria for performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document because the submission strategy relied on substantial equivalence based on technological similarity and non-clinical testing rather than performance studies against defined quantitative acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study":
Acceptance Criteria (Inferred from Non-Clinical Testing and Device Functionality):
Since no performance metrics are given, the acceptance criteria are implicitly related to the successful functionality and safety of the remote scanning feature. These would likely be qualitative or functional:
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary) |
|---|---|
| 1. Successful Remote Control of MR Imaging Device | Demonstrated through non-clinical verification and validation testing on a subset of GE HealthCare MRI systems. |
| 2. Successful Remote Scan Initiation | Demonstrated through non-clinical verification and validation testing on a subset of GE HealthCare MRI systems. |
| 3. Real-time Communication Mechanisms (Onsite & Remote Users) | Device described as providing real-time communication mechanisms; functionality tested during design verification. |
| 4. Access Granting Mechanism by Onsite User | Functionality described and tested: "Access must be granted by the onsite user circulating the system." |
| 5. No New Potential Safety Risks Introduced | Concluded based on design verification and validation testing; no unexpected test results or safety issues observed. |
| 6. Proper Implementation of Design Requirements | Verified through design control testing per GE HealthCare's quality system (e.g., Requirement Definition, Risk Analysis, Technical Design Reviews). |
| 7. Maintenance of Safety & Effectiveness | Confirmed by design verification and validation testing, concluding it has not been affected. |
Study Information (Based on Non-Clinical Testing):
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in a clinical study. The testing was conducted on a "subset of GE HealthCare MRI systems" on the bench. This implies a sample of hardware configurations rather than patient data.
- Data Provenance: Not applicable as it was non-clinical "bench" testing, not involving patient data or a specific country of origin for such data. It was performed internally by GE HealthCare.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. As this was non-clinical, functional testing, there was no "ground truth" in the clinical diagnostic sense established by experts. Testing would have involved engineers and quality assurance personnel verifying the system's intended functionality.
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Adjudication Method for the Test Set:
- Not applicable for functional verification testing. Adjudication methods are typically used when comparing human interpretations or algorithmic outputs against a gold standard in diagnostic or clinical performance studies.
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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 document explicitly states: "The subject of this premarket submission, Digital Expert Access with Remote Scanning did not require clinical studies to support substantial equivalence..." The device is a remote control and collaboration tool, not an AI-assisted diagnostic device meant to improve human reader performance.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable in the context of performance. The device is inherently a "human-in-the-loop" collaboration tool. While its technical components were likely tested in isolation (standalone components), the overall device's "performance" is tied to its functional remote control and communication capabilities, not an algorithmic diagnostic output.
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The Type of Ground Truth Used:
- For the non-clinical testing, the "ground truth" was the pre-defined design requirements and expected functional behavior of the device. This is typical for engineering verification and validation testing, where the "truth" is whether the system performs as designed and specified (e.g., does the remote expert successfully initiate a scan?).
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The Sample Size for the Training Set:
- Not applicable. The document does not describe the device as employing machine learning or AI that would require a "training set" of data in the sense of a deep learning model. It is a control and communication software system.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set for a machine learning model is mentioned, ground truth establishment for such a set is irrelevant to this submission.
In summary, the FDA 510(k) clearance for this device was based on a demonstration of "substantial equivalence" to existing predicate devices through non-clinical design verification and validation testing, focusing on ensuring the new remote scanning feature did not introduce new safety or effectiveness issues, rather than requiring quantitative performance studies with clinical acceptance criteria.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.