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510(k) Data Aggregation
(82 days)
The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for different modalities including CR, DR, CT, MR, NM, ECG, and US.
Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed by FDA for mammography.
CARESTREAM Vue Motion with ECG Feature is a Light Viewer designed to provide wireless and portable access to medical images for remote reading or referral purposes from web browsers including enterprise distribution of radiology images and related data. The modification to the Vue Motion device described in this submission includes the addition of software to facilitate display of ECG data.
The provided text describes a 510(k) submission for the "CARESTREAM Vue Motion" device, specifically detailing the addition of an ECG display feature. The focus of this document is on establishing substantial equivalence to previously cleared predicate devices, rather than an in-depth clinical study demonstrating acceptance criteria met by the device's performance in a diagnostic context. Therefore, much of the requested information regarding a study proving the device meets acceptance criteria, such as sample size for test sets, data provenance, ground truth establishment, or human reader effectiveness, is not present.
However, based on the information provided, we can extract details concerning the device's intended use, the "testing" performed for this specific modification, and the basis for its clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative clinical acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity). Instead, the acceptance criteria for this modification revolve around functional equivalence and safety. The performance is reported as meeting these functional requirements.
| Acceptance Criteria (Implicit from "Discussion of Testing") | Reported Device Performance |
|---|---|
| Software Verification | Functioned as intended by product/design requirements. |
| Security Testing | Functioned as intended by product/design requirements. |
| Accuracy of ECG Display (Simulated User Test) | Verified by comparing sample waveform data, patient information, and measurement information obtained from the source data to what was displayed and measured using Vue Motion. The application functioned as intended. |
| Substantial Equivalence to Predicate Devices | Demonstrated through functional similarity and non-alteration of fundamental scientific technology. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The testing mentioned is "non-clinical (bench) testing" and "simulated user test environment." This suggests functional testing with sample data rather than a clinical study with a patient cohort.
- Data Provenance: Not specified, but referred to as "sample waveform data, patient information, and measurement information obtained from the source data." This implies synthetic or pre-existing (possibly de-identified) data used for functional verification rather than patient data from a specific country or collected prospectively/retrospectively for a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The "ground truth" in this context appears to be the "source data" used for comparison in the simulated user test, and the exact method of its establishment or the experts involved are not detailed.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Given the nature of the testing (functional verification against source data), a formal adjudication method for diagnostic consensus among experts is not described.
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, a MRMC comparative effectiveness study was not done. The device is a "Light Viewer" for display and access, not an AI-powered diagnostic tool, and the submission primarily focuses on the addition of an ECG display feature, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not directly applicable in the terms of a diagnostic algorithm's standalone performance. The device itself is a viewer, and its "performance" is its ability to accurately display medical data. The "Discussion of Testing" describes verifying the functionality and accuracy of this display against source data, which can be considered a form of standalone verification of the display component. However, it's not a standalone diagnostic algorithm performance study.
7. The Type of Ground Truth Used
- The "ground truth" for the "simulated user test environment" was "source data" comprising "sample waveform data, patient information, and measurement information." This implies a reference set of known-correct data points against which the device's display accuracy was compared.
8. The Sample Size for the Training Set
- Not applicable. This device is a display software, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
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