(153 days)
The PocketECG IV is intended to be used by:
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Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
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Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
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Patients with palpitations without known arrhythmias to obtain a correlation of rhythm with symptoms.
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Patients who require monitoring of the effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
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Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
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Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias.
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Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to arrial fibrillation or atrial flutter.
Data from the device may be used by another device to analyze. measure or report OT interval. The device is not intended to sound any alarms for QT interval changes.
Contraindications:
The PocketECG IV is not intended to be used by:
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Patients who have been diagnosed with life-threatening arrhythmias and require hospitalization.
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Patients who require inpatient monitoring using a life-saving device.
The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV, type P4TR-AA-ADS is an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and the entire ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff.
Here's a breakdown of the acceptance criteria and study information for the Unified Arrhythmia Diagnostic System PocketECG IV, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission references compliance with the IEC 60601-2-47:2012 standard for arrhythmia detection algorithms. The text explicitly states: "Test results were considered to be in complaint with standard requirements." However, concrete numerical acceptance criteria and specific performance metrics (e.g., sensitivity, specificity, accuracy for various arrhythmia types) from this standard are not detailed in the provided document. The document implies that the device meets the standard but doesn't provide the standard's exact requirements or the device's specific results against those requirements.
Similarly, for wireless transmission, the document states: "Wireless transmission performance has been tested according to Verizon Open Development (based on CTIA) requirements for LTE data transmissions." Again, the specific numerical acceptance criteria and detailed performance results are not provided.
Therefore, I can only create a table that states the areas tested and the general conclusion of compliance, not a detailed comparison of specific numerical acceptance criteria versus reported performance.
| Test Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Arrhythmia Detection | Compliance with IEC 60601-2-47:2012 | In compliance with standard requirements |
| Wireless Transmission | Compliance with Verizon Open Development (based on CTIA) for LTE | Tested according to requirements; implicitly in compliance |
| Electrical Safety & EMC | Compliance with US electrical safety and EMC standards | Fully complying with US electrical safety and EMC standards |
| General Product Performance | Meets requirements of various IEC and AAMI standards (listed in document) | Performance data not specified, but general compliance claimed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "performance testing according to IEC 60601-2-47:2012" but doesn't provide any details about the dataset used for this testing, including the number of patients, recordings, or specific arrhythmias.
- Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The document does not describe how ground truth was established for the performance testing, nor does it mention the involvement or qualifications of experts for this purpose.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No indication of an MRMC comparative effectiveness study being performed or reported in the provided text. The submission focuses on device performance against standards, not on human-AI collaboration or improvement metrics.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance: Yes, a standalone performance study was implicitly done for the arrhythmia detection algorithms. The text states: "Arrhythmia detection algorithms implemented in PocketECG IV have been subject for performance testing according to IEC 60601-2-47:2012 (AAMI / ANSI / IEC 60601-2-47:2012)." This refers to the algorithm's performance in detecting arrhythmias against established standards, without human intervention as part of the testing methodology described. While the overall system involves human review, the specific performance testing mentioned here would be for the automated algorithm's accuracy.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. While performance testing against IEC 60601-2-47:2012 implies a comparison to a known, verified "true" state of cardiac rhythms, the method by which this ground truth was established (e.g., expert consensus, pathology, other validated methods) is not detailed in the document.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated. The document makes no mention of a training set or its size, which is common for submissions primarily focused on verification and validation of a developed product rather than describing the entire development process of an AI model from scratch.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not explicitly stated. Since a training set isn't mentioned, the method for establishing its ground truth is also not provided.
§ 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.