(226 days)
The indications for use for the PocketECG v2 monitor are as follows:
- 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
- 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)
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
- Patients with diagnosed sleep disordered breathing including sleep annea (obstructive, central) to evaluate possible nocturnal arrhythmias
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial 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 OT interval changes.
PocketECG v2 - Medicalgorithmics Unified Arrhythmia Diagnostic System 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.
The patient worn transmitter streams via Bluetooth link the ECG signal to a Windows Mobile or Android OS operated PDA (Personal Digital Assistant) device with mobile phone capabilities. The PDA runs Medicalgorithmics proprietary software which produces QRS annotations and manages the data transmission. The PDA device transmits and stores the entire ECG on its storage card.
The provided 510(k) summary for the Medicalgorithmics PocketECG v2 system describes the device, its indications for use, and a comparison to predicate devices, but it does not include specific acceptance criteria or a detailed study section proving the device meets those criteria.
A 510(k) summary typically focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria as would be found in a full submission or a scientific publication. The document states that the device "meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" and lists several IEC and AAMI/ANSI standards. This implies that the device was tested against the requirements of these standards, but the specific acceptance criteria and detailed findings of those tests are not presented in this summary.
Therefore, many of the requested details about the study are not available in the provided text.
Here is a summary of what can be extracted or inferred from the provided document, with notes on what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (General) Meeting requirements of referenced standards: | Meets requirements of: |
| - IEC 60601-1:1999 (Safety) | Conforms to standard |
| - IEC 60601-1-2:2001/A1:2004 (EMC, Class B) | Conforms to standard |
| - AAMI/ANSI EC38:2007 (Ambulatory ECG systems) | Conforms to standard |
| - AAMI/ANSI EC57:1998/(R)2003 (Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms) | Conforms to standard |
| (Specific to Arrhythmia Detection) | Not explicitly stated in the document. The document refers to the device analyzing ECG signals, classifying heart beats, and recognizing rhythm abnormalities, but does not provide specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection, QRS detection accuracy) or acceptance thresholds. |
| (General) Safety and Effectiveness | Stated as "safe, effective and substantially equivalent" to predicate devices. |
Missing: Specific quantitative acceptance criteria (e.g., minimum sensitivity/specificity for Afib detection, QRS detection accuracy thresholds) and the exact quantitative results from performance testing.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document mentions "performance testing" was conducted, but does not specify the dataset used for such testing (e.g., number of recordings, duration, patient demographics, country of origin, whether it was retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. The summary does not detail how ground truth was established for any performance testing.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
This information is not provided in the 510(k) summary. The document focuses on the device's standalone capabilities and its equivalence to predicate devices, not on human-AI collaboration for improved diagnostic accuracy. The device produces "QRS annotations" and "classification results" to be reviewed by "trained medical staff," suggesting human-in-the-loop, but no MRMC study details are given.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The device "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... for reviewing by trained medical staff." This indicates that the algorithm performs its analysis standalone before human review. However, the quantitative performance metrics for this standalone analysis are not provided in the summary.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This information is not provided in the 510(k) summary. While it is highly probable that expert-annotated ECG recordings would have been used as ground truth for any arrhythmia detection performance testing, the document does not confirm this or describe the process.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. The document does not discuss the development or training of the algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the 510(k) summary.
§ 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.