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;
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 apnea (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 QT interval. The device is not intended to sound any alarms for QT interval changes.

Device Description

PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV 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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. While it outlines the device's indications for use, contraindications, and general technical specifications, it lacks the precise performance metrics, study design, and results typically found in such a document.

Here's an analysis based on the available information and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The text mentions that the device "meets the requirements of following performance standards" (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, and AAMI/ANSI EC57:2012), but it does not specify the numerical acceptance criteria derived from these standards for arrhythmia detection and the actual reported performance of the PocketECG III against those criteria.

2. Sample size used for the test set and data provenance:

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the document. The text mentions "reviewing by trained medical staff" at a Monitoring Center, but it doesn't quantify or qualify these individuals regarding ground truth establishment for a test set.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

This information is not provided in the document. The filing focuses on the device itself and its equivalence to a predicate, not on a human-in-the-loop study.

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

The document implies standalone performance testing against standards, as it states the device "analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities." It also mentions meeting "requirements of following performance standards," which would necessitate standalone testing of the algorithm's accuracy against a known truth. However, the specific details and results of such testing are not provided.

7. The type of ground truth used:

This information is not explicitly stated in the document. Given the nature of arrhythmia detection devices and the reference to standards like AAMI/ANSI EC57:2012, it is highly probable that the ground truth would involve expert cardiac rhythm annotations on ECG recordings. However, 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 document.

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

This information is not provided in the document.

Summary of what is present and relevant:

Device: PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV
Purpose: Ambulatory ECG monitor that analyzes electrographic signals, classifies heartbeats, and recognizes rhythm abnormalities.
Process: Detects, annotates, and transmits ECG signal and detection results via cellular network to a remote server for review by trained medical staff.
Standards Mentioned: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, and AAMI / ANSI EC57:2012. The document states the device "meets the requirements" of these standards. This implies that some form of performance testing against criteria derived from these standards was conducted for substantial equivalence.

In conclusion, the provided text is a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards. It does not delve into the detailed scientific study design, specific performance metrics, and results that would fully address all parts of your request regarding acceptance criteria and their proof.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2015

Medicalgorithmics S.A. % Martin Jasinski Vice President Medicalgorithmics LLC 245 West 107th Street Suite 11 A New York, New York 10025

Re: K152550

Trade/Device Name: PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: August 5, 2015 Received: September 8, 2015

Dear Martin Jasinski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K152550 Device Name: PocketECG III -Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV

Indications For Use:

The indications for use for the PocketECG III 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;
1. 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);
1. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms;
1. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation);
1. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring;
1. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias;
1. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter;
1. 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.

Contradictions:

1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring;
1. Patients who the attending physician thinks should be hospitalized.

Prescription Use AND/OR AND/OR AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (CONTINUE ON A SEPARATE PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

August 4, 2015

1. Submitter Name and Address
Medicalgorithmics LLC	245 West 107th St., Suite 11ANew York, NY 10025, USA
Contact Person	Martin Jasinski, phone (917) 9419581,fax (817) 5829527
2. Device
Trade name:	PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System
Type	PECGT-IIIV
Classification name:	Arrhythmia Detector and Alarm
Product code:	DSI
Regulation no:	870.1025
Class:	Class II, Special Controls

3. Substantial Equivalence

The PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV is a modification of a legally marked Medicalgorithmics predicate device:

. PocketECG v3 - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-III; K124060 (Reg. no. 870.1025)
Note: For commercial reasons Medicalgorithmics S.A. launched the medical device onto the U.S. market under the name of PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, and has continued to distribute the device under the same name. The modified device is the latest evolution of this predicate one.

4. Device Description

5. Indications for Use and contradictions

The indications for use for the PocketECG III, type PECGT-IIIV monitor are as follows:

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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 bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and mvocardial infarction: and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease:

1. 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);
1. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms;
1. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation);
1. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring:
1. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias;
1. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter;
1. 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 OT interval changes.

Contradictions:

1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
1. Patients who the attending physician thinks should be hospitalized.

6. Predicate Device Information

To K124060 - PocketEG v3 - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-III

Similarities:
- o The subject device and the predicate device have the same fundamental scientific technology and intended use:
- o The subject device and the predicate device have the same components: transmitter, lithium-ion rechargeable batteries, AC plug-in battery charger and PC application:
- o The subject device and the predicate device analyze electrographic signal, classify all detected heart beats and recognize rhythm abnormalities:
- o The subject device and the predicate device send all detection results, including annotations for every detected heart beat and the entire ECG signal via cellular telephony network to a remote server;
- Differences: -

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The predicate device uses a Global System for Mobile Communication (GSM) o protocol, whereas the subject device uses Code Division Multiple Access protocol (CDMA) for data transmission to a remote server.

7. Referenced standards

The PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm like the predicate device.

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) "Medical electrical . equipment - Part 1: General requirements for basic safety and essential performance", with National Differences for United States (US) ANSI/AAMI ES 60601-1:2005/A2:2010 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance",
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
. IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment,
IEC 60601-2-47:2012 Medical electrical equipment Part 2-47: Particular . requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
. AAMI / ANSI EC57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms.

Quality management system - Medical devices is in conformance with the standards: EN ISO 13485:2012 + EN ISO 13485:2012/AC:2012, ISO 13485:2003 under CMDCAS and EN ISO 9001:2008.

8. Substantial Equivalence Conclusion

PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV is safe, effective and substantially equivalent to the predicate device as supported by the descriptive information and the performance testing. The subject device is composed of off-the-shelf, certified devices and components fully complying with the US safety and EMC standards.

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.