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Configuration 1) Holter Mode: The MobileECG 2 BT is intended to record continuous data for 30+ days for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as: Palpitations, shortness of breath, chest pain, syncope, evaluating pacemakers, heart rate variability's, and clinical studies. The MobileECG 2 BT device transmits all collected data to a call center for interpretation using the TM eCloud ECG Analysis System at the end of the completed study.

Configuration 2) Mobile Cardiac Telement Mode: The MobileECG 2 BT is intended to continuously monitor, transmit, and record data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device continuously transmits data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

Configuration 3) Event Mode: The MobileECG 2 BT is intended to monitor and record patient activated data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device transmits all patient event activated data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

The MobileECG 2 BT is intended for use in adults and children of any age from birth upwards.

The MobileECG 2 BT and the TM eCloud ECG Analysis System interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The MEMTEC MobileECG 2 BT digital Monitor provides high resolution recording of patient ECG data and pacemaker spike detection for a period of up to 30 Days. The 3 in 1 Multi - Function BT monitor provides Holter, Event, and MCT ambulatory use. The data is stored on a removable Micro SD Card and no data compression is used. The data can be downloaded by a USB 3.0 cable, BT, or removable Micro SD Card. The BLE 4.1 (Bluetooth) sends patient data to cell phone continuous for 30 days for use as an Event or MCT Monitor. The patient ID/Date/Time is stamped on the recording every 2 minutes preventing the mixing of data with another patients data. The large LCD provides real time patient ECG signals and confirms lead hook-ups. In Holter Mode the unit has selectable sample rates of 250, 500, or 1000 samples per second with resolution of 12bits. The MobileECG 2 BT operates on a single "AAA" alkaline or "AAA" lithium battery.

Configuration 1 (Holter Mode): MobileECG 2 BT is used with the TM eCloud Analysis System (K142349) for Holter monitoring. In Holter usage, data is recorded for the prescribed duration and then uploaded and analyzed after the recording period has ended. The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

Configuration 2 (MCT Mode): MobileECG 2 BT is combined with a special purpose cell phone and Android APP to store and transmit real-time ECG to the TM eCloud Analysis System (K142349) to provide Mobile Cardiac Telemetry (MCT). The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

Configuration 3 (Event Mode): MobileECG 2 BT is combined with a special purpose cell phone and Android APP to store and transmit real-time ECG on patient activated events to the TM eCloud Analysis System (K142349). The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

The Memtec Corporation's MobileECG 2 BT device underwent testing to demonstrate its substantial equivalence to predicate devices. The study information is extracted from the provided text.

1. Acceptance Criteria and Reported Device Performance

The provided document describes a comparison of technical specifications and indications for use between the subject device (MobileECG 2 BT) and two predicate devices (Preventice BodyGuardian and Memtec Corporation Model 950-12L). The primary acceptance criteria for establishing substantial equivalence were that differences in technological specifications should not raise any new issues of safety or effectiveness. The document concludes that "the differences in the above "Technological Specifications" between the devices do not raise any new issues of safety or effectiveness, demonstrating that the subject device is as safe and as effective as the predicated devices."

A table comparing the technical specifications of the MobileECG 2 BT with the predicate devices is provided in the source document. Since the reported performance is largely a qualitative statement of "Same" or "Different" with a justification for why the difference does not affect safety or effectiveness, a direct quantitative comparison of acceptance criteria vs. specific reported device performance values for each technical specification is not explicitly detailed in a pass/fail format within this document. The conclusion states all criteria were met to establish substantial equivalence.

Conclusion: The provided document states that the MobileECG 2 BT's performance testing results demonstrate that the differences in "Technological Specifications" do not raise any new safety or effectiveness issues, and that the "Indications For Use" are substantially equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a separate test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The assessment of substantial equivalence relies on comparison of technical specifications and indications for use against predicate devices validated against recognized FDA standards. The non-clinical tests mentioned are conformance to these standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for a test set. Substantial equivalence was determined through comparison to predicate devices and conformance to recognized standards.

4. Adjudication Method

The document does not mention any adjudication method as no expert review or human evaluation of a test set is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study, nor does it provide information on human reader improvement with or without AI assistance. The device is a data acquisition system that transmits data to an existing analysis system (TM eCloud ECG Analysis System, K142349).

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for the MobileECG 2 BT itself in terms of diagnostic accuracy. Instead, it states that "The MobileECG 2 BT and the TM eCloud ECG Analysis System interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG." The MobileECG 2 BT is primarily a data acquisition device, and its performance is evaluated through its conformity to established medical device standards and comparison of its technical specifications to predicate devices. The TM eCloud ECG Analysis System is a referenced device (K142349), suggesting its own performance would have been established separately.

7. Type of Ground Truth Used

For the MobileECG 2 BT device itself, the ground truth for performance assessment seems to be derived from compliance with FDA-recognized consensus standards (e.g., ANSI/AAMI ES60601-1-2005, IEC 60601-1-2:2014, ANSI/AAMI-IEC 60601-2-47-2012, ANSI/AAMI EC53:1995). The document does not describe a clinical study with pathology or outcomes data specifically for the MobileECG 2 BT's diagnostic performance for arrhythmias, as it functions as a data recorder for an analysis system.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The MobileECG 2 BT is a hardware device for ECG data acquisition; it does not explicitly describe an AI algorithm or model that would require a training set. The referenced "TM eCloud ECG Analysis System" (K142349) would be the component that uses algorithms and would likely have had its own training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for the MobileECG 2 BT, there is no information provided on how its ground truth would have been established.

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