Medicalgorithmics Unified Cardiac Rehabilitation System

• K Number: K173969
• Device Name: Medicalgorithmics Unified Cardiac Rehabilitation System
• Manufacturer: Medicalgorithmics S.A.
• Date Cleared: 2018-07-11 ( 194 days)
• Product Code: DSI , MHX
• Regulation Number: 870.1025
• Type: Abbreviated
• Panel: CV
• Reference & Predicate Devices: K124060 , K041607

Intended Use

PocketECG CRS is intended to be used for:

1. Cardiac monitoring of patients undergoing a cardiac rehabilitation program. Its main feature is patient monitoring during previously planned training sessions and training assistance to achieve desired intensity and duration of workout. Training session parameters such as heart rate threshold, session duration (time intervals and number of repetitions) are defined by the physician for each patient individually. Additionally, the transmitter allows continuous ECG monitoring between trainings, during patient daily activities.

2. All patients hospitalized with a primary diagnosis of an acute myocardial infarction (MI) or chronic stable angina (CSA), or who during hospitalization have undergone coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, referred to an early outpatient cardiac rehabilitation or secondary prevention (CR) program.

3. All patients evaluated in an outpatient setting who within the past 12 months have experienced an acute myocardial infarction (MI), coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, or who have chronic stable angina (CSA) and have not already participated in an early outpatient cardiac rehabilitation or secondary prevention (CR) program for the qualifying event or diagnosis, referred to such a program.

4. Patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and internittent 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;

5. PocketECG CRS can be used to monitor the training session in hospital, rehabilitation center or physicians office under supervision of qualified staff.

Device Description

Medicalgorithmics Unified Cardiac Rehabilitation System PocketECG CRS is an ambulatory system which can be used for patient monitoring during previously planned cardiac rehabilitation training sessions and training assistance to achieve desired intensity and duration of workout. The system measures patient's physical activity and ECG signal, classifies all detected heart beats and recognizes rhythm abnormalities. PocketECG CRS can be also used for patient's monitoring between training sessions as 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 beats and the entire ECG signal are transmitted via cellular network to a remote server accessible by a Monitoring Center for review by trained medical staff.

AI/ML Overview

The provided text is a 510(k) summary for the Medicalgorithmics Unified Cardiac Rehabilitation System PocketECG CRS. It details the device's indications for use, technological comparison to predicate devices, and adherence to various standards and guidance documents. However, it does not include specific tables of acceptance criteria with reported device performance, nor does it provide details on the study design elements such as sample sizes for test/training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, or MRMC comparative effectiveness study results.

The section titled "IX. Performance data" states:
"Arrhythmia detection algorithms implemented in PocketECG CRS (PECGT-III) and PocketECG III (PECGT-IIIR) have been subject for performance testing according to IEC 60601-2-47:2012 (AAMI / ANSI / IEC 60601-2-47:2012) Test results were considered to be in complaint with standard requirements."

This statement indicates that performance testing was conducted and met the requirements of the specified standard, but it does not provide the qualitative or quantitative results needed to populate the requested table or answer the specific questions about the study methodology.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Cannot be fully provided. The document states that "Test results were considered to be in complaint with standard requirements" (IEC 60601-2-47:2012), implying acceptance criteria from that standard were met. However, the specific acceptance criteria and the reported performance metrics (e.g., sensitivity, specificity for various arrhythmias) are not explicitly listed in a table.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not specify the sample size for the test set or the provenance of the data used for performance testing (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. The document does not describe how ground truth was established for the performance testing, nor does it mention the number or qualifications of any experts involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. The document does not describe any adjudication method used for the test set.

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

• Cannot be provided. The document makes no mention of an MRMC comparative effectiveness study or human reader improvement with AI assistance. The performance testing described appears to be for the algorithm's standalone performance against a standard.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Likely yes, based on the text. The statement "Arrhythmia detection algorithms implemented in PocketECG CRS (PECGT-III) and PocketECG III (PECGT-IIIR) have been subject for performance testing according to IEC 60601-2-47:2012" implies standalone algorithmic performance was assessed against a standard. There is no mention of human-in-the-loop performance studies described in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided specifically. While it's implied that there was a ground truth or reference standard against which the arrhythmia detection algorithms were tested, the document does not specify the type of ground truth (e.g., whether it was expert consensus, manually annotated ECGs, etc.).

8. The sample size for the training set

• Cannot be provided. The document does not mention the training set or its size.

9. How the ground truth for the training set was established

• Cannot be provided. As the training set is not mentioned, its ground truth establishment is also not described.

In summary, the provided 510(k) summary confirms that performance testing (specifically for arrhythmia detection algorithms) was conducted in accordance with IEC 60601-2-47:2012 and found to be "in complaint with standard requirements." However, it lacks the detailed quantitative and qualitative results, and the specifics of the study methodology (sample sizes, data provenance, ground truth establishment, expert involvement, or any human-in-the-loop studies) that your request entails.

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.