(175 days)
The EMMa system is intended for diagnostic evaluation of patients who experience transient symptomatic events that may suggest non-lethal cardiac arthythmia to support and possibly improve an ongoing treatment by the patient's physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physician for review.
EMMa (Electronic Monitoring Management) is the server part of a telemedical system to receive data from the ambulatory ECG monitors Kate Loop (Event Monitor) and Kate MCT (Mobile Cardiac Telemetry; similar to Loop but with additional functions like trend data and streaming). Physiological data recorded by the ECG monitors are transmitted via their GSM module (cellular telephon network) to the server EMMa. The detection of arrhythmias and other cardiac conditions is done on the ECG monitoring device, not on the EMMA, and is not scope of this 510k. EMMa is provided to be installed in a Telemonitoring Service Centre (TSC). ECG-technicians / Agents working there generate patient reports from physiological data with the aim to send the reports to the patients' physicians. No interpretation of data is performed by the server software. The generated reports support physicians in adapting the therapy. EMMa is not designed for and compatible with iOS and Android.
The provided text does not contain detailed acceptance criteria for the EMMa device's performance, nor does it describe a study specifically designed to "prove" the device meets such criteria in terms of clinical accuracy or effectiveness.
The document is a 510(k) premarket notification letter and summary, primarily focusing on establishing substantial equivalence to a predicate device. It highlights software verification and validation activities and other non-clinical performance data, but clinical performance data was not required for the substantial equivalence determination.
Therefore, many of the requested details, such as specific performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not available in the provided text.
Here's what can be extracted and what information is missing:
Missing Information:
- A table of acceptance criteria and reported device performance (specifically for clinical accuracy)
- Sample size used for the test set
- Data provenance for clinical testing
- Number of experts used to establish ground truth
- Qualifications of experts establishing ground truth
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI assistance
- Whether a standalone (algorithm only) performance study was done (the document states arrhythmia detection is done on the ECG monitoring device, not the EMMa software)
- The type of ground truth used for clinical effectiveness (as clinical data was not required)
- Sample size for the training set (no mention of a training set for clinical performance)
- How ground truth for the training set was established (no mention of a training set for clinical performance)
Available Information (related to non-clinical performance and design):
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A table of acceptance criteria and the reported device performance:
- The document implies that the device "meets all the stated requirements and passed all the testing noted above." However, specific numerical performance metrics (e.g., sensitivity, specificity for arrhythmia detection) are not provided. The "acceptance criteria" appear to be compliance with relevant standards (IEC 62304, IEC 62366-1) and software verification/validation.
Acceptance Criterion (Implied) Reported Device Performance Compliance with IEC 62304 (Medical Device Software life cycle) Passed; documentation provided Compliance with FDA Guidance for Software Contained in Medical Devices Software verification and validation conducted; documentation provided Software Level of Concern (Moderate) satisfied Yes Compliance with IEC 62366-1 (Usability engineering) Passed Meeting "all stated requirements" (General design/functionality) EMMa meets all stated requirements -
Sample size used for the test set and the data provenance:
- Not provided for clinical performance. The "test set" mentioned refers to software verification and validation, not a clinical dataset for diagnostic accuracy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided for clinical performance. Clinical ground truth establishment was not part of the required testing for the 510(k) pathway for this device.
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Adjudication method for the test set:
- Not applicable/Not provided for clinical performance.
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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. The document explicitly states "Clinical data were not required to support the safety and effectiveness of the device EMMa." Furthermore, the EMMa is a server system designed to receive data and present it for human review by ECG-technicians and physicians; it does not perform final diagnostic interpretation or AI-driven assistance that would typically be evaluated in an MRMC study comparing human performance with and without AI. The arrhythmia detection algorithm itself resides on the ambulatory ECG monitoring devices (e.g., Kate Loop, Kate MCT), not on the EMMa server, and "is not scope of this 510k."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The document clarifies that the arrhythmia detection is done on the ECG monitoring device, not on the EMMa software. EMMa is a server system for managing, storing, and forwarding data for human review.
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The type of ground truth used:
- For the non-clinical software testing, the "ground truth" would be the expected functional behavior and output based on design specifications and regulatory standards. Clinical ground truth (e.g., pathology, outcomes data) was not used as clinical data was not required.
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The sample size for the training set:
- Not provided. Clinical training data is not discussed as clinical studies were not performed for this 510(k).
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How the ground truth for the training set was established:
- Not provided. (See point 8).
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.