MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG

• K Number: K090037
• Device Name: MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
• Manufacturer: MEDICALGORITHMICS SP Z.O.O.
• Date Cleared: 2009-05-22 ( 136 days)
• Product Code: DSI , MLO
• Regulation Number: 870.1025
• Type: Abbreviated
• Panel: CV
• Reference & Predicate Devices: K072558 , K071995

Intended Use

The indications for use for the PocketECG monitor are as follows:

1. 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 bradyarrhythmias 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
2. 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)
3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes.

Device Description

PocketECG - Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector 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 ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff. The data transmission is automatically triggered when abnormalities are detected, or periodically in case of normal ECG.

The patient worn transmitter streams via Bluetooth link the ECG signal to a Windows Mobile operated PDA (Personal Digital Assistant) device with mobile phone capabilities. The PDA runs Medicalgorithmics proprietary software which detects the ECG annotations and manages the data transmission. The PDA device stores entire ECG on its storage card.

AI/ML Overview

The provided 510(k) summary for the PocketECG - Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector does not contain specific acceptance criteria or a detailed study description proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices, device description, and indications for use, as typically required for a 510(k) submission.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

Missing Information from the Provided Text:

• 1. A table of acceptance criteria and the reported device performance: This is not present. The document refers to meeting performance standards like AAMI/ANSI EC57:1998 for cardiac rhythm and ST-segment measurement algorithms, but it does not specify concrete acceptance criteria (e.g., sensitivity, specificity, accuracy targets for specific arrhythmias) or report the PocketECG's performance against such criteria.
• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 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: An MRMC study is not mentioned. The device is an "Arrhythmia Detector and Alarm" that transmits data to a "Monitoring Center for reviewing by trained medical staff," implying a human-in-the-loop, but no comparative effectiveness study on human reader improvement with AI assistance is described.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device has an "arrhythmia analysis algorithm," no standalone performance study without human-in-the-loop review is explicitly detailed with specific metrics.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
• 8. The sample size for the training set: Not mentioned.
• 9. How the ground truth for the training set was established: Not mentioned.

Information that can be inferred from the text, but doesn't directly answer the questions about acceptance criteria and performance study:

• Referenced Standards: The device meets the requirements of "AAMI / ANSI EC57:1998/(R)2003 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms." This standard would outline methodologies for testing and what a manufacturer should report, but the 510(k) summary itself does not contain the results of such testing or specific acceptance criteria.
• Technological Comparison: The document notes that the "subject device uses an arrhythmia analysis algorithm developed by Medicalgorithmics while the predicate devices use arrhythmia analysis algorithm licensed from Mortara (K072558) or their proprietary algorithms (K071995)." This highlights the proprietary algorithm but doesn't detail its validation.
• General Declaration of Safety and Effectiveness: The conclusion states: "Medicalgorithmics ECG Monitor and Arrhythmia Detector, PocketECG is safe, effective and substantially equivalent to the predicate devices as supported by the descriptive information and the performance testing." This is a general statement required in a 510(k), not a detailed study report.

In summary, the provided text serves as a 510(k) summary focusing on substantial equivalence and regulatory compliance, not a detailed technical report of performance studies against specific acceptance criteria. To obtain the requested information, one would typically need to review the full 510(k) submission, which would include detailed test reports and validation studies not present in this summary document.

Regulation Number and Section

§ 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.