(31 days)
Epiphany Cardio Server Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or received by the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software application is intended to be used from a mobile device to perform the following:
· View ECG test results, such as waveforms, measurements and diagnosis statements as well as other relevant current or historical patient information originally stored, analyzed or received by the Cardio Server ECG Management System.
· View the ECG lead traces using different display settings.
· Compare the results of current ECG tests with the patient's previous ECG test results stored on the Cardio Server ECG Management System.
· Perform manual ECG-related measurements using the electronic caliper tool.
· Communicate information with the Cardio Server ECG Management System such as login credentials and user settings.
Epiphany Cardio Server Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators. Epiphany Cardio Server Mobile is not intended for real time monitoring.
The Epiphany Cardio Server Mobile provides secure access to ECG records and related information contained on the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software functions as an accessory to the Cardio Server ECG Management System, and requires a WIFI or cellular connection to a pre-installed and properly configured Cardio Server ECG Management System. Through providing remote access to the ECG data stored on the Cardio Server ECG Management System, the user is able to review current and previous ECG tests, results, and perform measurements on the ECG waveforms. Cardio Server Mobile does not store ECG or patient related information on the mobile device, does not directly communicate with cardiographs or other waveform acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data. The device does not allow modification of the original ECG traces (waveforms) stored on the Cardio Server ECG Management System.
The Epiphany Cardio Server Mobile application is not intended to replace the functionalities provided by the Cardio Server ECG Management System desktop client but to extend those to make selected functionalities described above available via mobile devices.
The Epiphany Cardio Server Mobile functions as a non-real time system and is not intended for real time monitoring.
The Epiphany Cardio Server Mobile can be used both inside and outside of medical facilities except in areas where cellular phone or wireless device use is prohibited.
The Epiphany Cardio Server Mobile is intended to operate on Apple iPad and iPhone running iOS mobile operating system from Apple Inc.
The document is a 510(k) Summary for the Epiphany Cardio Server Mobile. It describes the device, its intended use, and a comparison to a predicate device.
However, the provided text does not contain specific acceptance criteria or the details of a study that proves the device meets those criteria in the way a clinical study for an AI/ML algorithm might.
Instead, it focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device for a mobile application that displays ECG data and allows for manual measurements, rather than performing automated analysis or diagnosis itself.
Therefore, for aspects like "Number of experts," "Adjudication method," "MRMC study," "Standalone performance," "Effect size," and "Ground truth," the document indicates these types of rigorous clinical validation studies were not performed because the device's function does not involve AI/ML for automated analysis or diagnosis.
Here's a breakdown based on the information provided and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Performance Section) | Reported Device Performance (from "Performance Data" and "Substantial Equivalence" sections) |
|---|---|
| Software Functionality: Meets all design specifications and requirements. | Cardio Server Mobile met all design specifications and requirements, as verified by unit and system level testing. |
| Operability with Predicate: Assured operability with the predicate McKesson Cardiology ECG Mobile application. | Unit and system level testing included assurance of operability with the predicate McKesson Cardiology ECG Mobile application. |
| User Accuracy Qualification (Display/Measurements): User accuracy qualification of ECG waveform and related information representation in a simulated user test environment. | User accuracy qualification of ECG waveform and related information representation in a simulated user test environment was performed. |
| Display and Measurement Capabilities: Verified using sample cases based on technical characteristics and relevancy to the intended function. | Bench testing verified the Cardio Server Mobile display and measurements capabilities using sample cases. |
| Display Manipulations: Adequacy of different display manipulations (e.g., full-screen display, zoom, navigating, orientation). | Testing considered different display manipulations. |
| Display Quality: Adequate user readability and image quality on a small screen. | Testing was performed to ensure adequate user readability and image quality on a small screen. |
| Display Accuracy: Accuracy when compared to original data presented by Cardio Server ECG Management System. | Testing was performed for display accuracy when compared to the original data as presented by Cardio Server ECG Management System. |
| Overall Function as Intended: Functions as per design requirements. | In all instances, the Epiphany Cardio Server Mobile functioned as intended by the design requirements. |
| Substantial Equivalence: Performance demonstrated substantial equivalence with the predicate device. | The observed results demonstrated substantial equivalence with the predicate device. Based on the performance test results, the Epiphany Cardio Server Mobile is substantially equivalent to the McKesson Cardiology ECG Mobile (K133534). |
| No New Safety/Effectiveness Questions: Differences from predicate do not raise new questions. | Any differences between the predicate device and Epiphany Cardio Server Mobile do not raise any new questions related to safety and effectiveness. |
| Security: Security testing performed. | Security testing performed. |
| Validation: Software validation performed. | Software validation performed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "sample cases" for bench testing and "simulated user test environment" but does not provide a specific numerical sample size (e.g., number of ECGs or users) for the test set.
- Data Provenance: Not specified. The data used for testing were likely internal, simulated, or pre-existing "sample cases" rather than a collected clinical dataset. The device receives data from the "Cardio Server ECG Management System" which would hold the actual patient data, but the testing described here is on the display and measurement tools of the mobile app, not the diagnostic content itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable in the context of an AI/ML ground truth study. The device's function is to display data and allow manual measurements, not to perform automated analysis or diagnosis that would require expert-established ground truth for algorithm performance. The testing was verification of display capabilities and accuracy against the source system.
4. Adjudication Method for the Test Set:
- Not applicable. As the device does not perform automated analysis requiring diagnostic ground truth, no adjudication method (like 2+1 or 3+1 consensus) was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No, an MRMC comparative effectiveness study was not done. The device (Epiphany Cardio Server Mobile) is a display and manual measurement tool for existing ECG data, not an AI/ML diagnostic aid. The testing focused on software functionality and display accuracy, not on how human readers' diagnostic accuracy changes with or without this specific mobile application. Therefore, there's no reported effect size regarding human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
- No, not in the context of an AI/ML algorithm. The device is a "software application" that functions as an accessory to an ECG management system. It "does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data." Therefore, there is no "algorithm only" performance to report as it's not an AI/ML diagnostic tool. Its "standalone" performance relates to its ability to display and allow manual measurements accurately, which was verified through "bench testing."
7. The Type of Ground Truth Used:
- Reference data from the Cardio Server ECG Management System. The "ground truth" for display accuracy and manual caliper measurements was the "original data as presented by Cardio Server ECG Management System." For functional aspects, the "design requirements" serve as the standard. This is not a clinical ground truth like pathology or outcomes data, but rather a functional and display accuracy ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that undergoes a "training" phase with a dataset. It's a software application designed for data display and manual measurement.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As no AI/ML training set was used, no ground truth needed to be established for such a set.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).