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The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments.

Faros Mobile provides the detection and reporting features appropriate for the indications below

• · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias.
• · Evaluation of patients for ST segment changes
• · Evaluation patients with pacemaker
• · Evaluating patient rest and stress ECG
• · Reporting heart rate variability analysis
• · Wireless transmission of patient ECG data and arrhythmia events for further analysis.

Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements.

Faros Mobile is contraindicated for

• · Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias
• · Pediatric patients weighting less than 10 kg

Faros Mobile is used for long term registration of a patient's heart electrocardiogram (ECG) and the wireless or wired transmission of the registered electrocardiogram arrhythmia events to a receiver or analysis system running on computer. The device is connected to a patient via electrode leads and the patient wears the device during the recording period and/or while he or she performs normal daily activities. The device is used with commercially available snap ECG electrodes.

Data is transferred to computer via USB. The ECG recording is analyzed at a medical facility using a Cardiac Navigator or Cardiac Explorer software.

In wireless transmission mode, Bluetooth communication protocol enables use of the Faros sensor as a part of a Mobile Cardiac Telemetry (MCT) or Cardiac Event Monitor (CEM) system. Data is transferred from device to companion device. For clarity, all the data is stored on sensor memory when the device operates via Bluetooth. The communication protocol is provided for 30° party integration purposes.

Device measurement configurations are managed via Faros Device Manager. The application operator can manage measurement configurations which include: ECG and motion data sampling frequencies, ECG channel count, heart rate variability, temperature, auto start and measurement auto stop features. Values for cardiac arrhythmia event detections are handled via Faros Manager application.

Faros Mobile system consists of:

• . Faros ECG sensor
  • o Bluetooth communication protocol and documentation for implementing interface for data collection from Faros sensor
  • channel and 3-channel cable sets o
  • general micro-USB cable for recharging device O
• Faros Manager application
• Cardiac Explorer application
• Cardiac Navigator application

The provided text is a 510(k) Premarket Notification for the Faros Mobile device, and it does not contain a specific study proving the device meets acceptance criteria in the way typically associated with algorithmic performance (e.g., accuracy, sensitivity, specificity benchmarks).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CARDIO SPY ECG Holter Systems by LABTECH KFT.) and a reference device (eMotion Faros ECG Mobile by Mega Electronics Ltd.) through non-clinical testing and conformance to recognized voluntary standards.

Therefore, many of the requested items regarding acceptance criteria and performance studies for an algorithm's performance cannot be directly extracted from this document, as the submission primarily relies on the established safety and efficacy of the predicate device and standardized testing for hardware and software functionality.

However, I can extract information regarding the general acceptance criteria implied by regulatory standards and the types of testing performed to demonstrate substantial equivalence.

Here's a breakdown based on the provided text, addressing what can be answered and where information is not present:

Implied Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Conformance)

Since a direct algorithmic performance study with specific numerical acceptance criteria is not provided, the "acceptance criteria" here are inferred from the demonstrated conformance to regulatory standards and the equivalence to predicate devices. The device performance is generally stated as meeting these standards.

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

Information Not Present in the Document for Algorithmic Performance

The following points pertain to a specific study proving device meets acceptance criteria for algorithmic performance (e.g., accuracy in arrhythmia detection), which is not detailed in this 510(k) submission. The submission relies on "performance tests" that validate compliance with general safety and functional standards, rather than detailing a specific clinical or annotated dataset study for the algorithm's diagnostic accuracy.

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

• Not provided. The document states "ECG and algorithm performance tests" were done, but does not detail the dataset used for these tests, its size, or provenance.

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)

• Not provided. Ground truth establishment for a test set is not detailed. The interpretation algorithm's analysis "must be confirmed by a physician with other relevant clinical information," suggesting the algorithm is an aid, but no specific number or qualification of experts for validating the algorithm's performance is mentioned.

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

• Not provided.

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

• No, an MRMC study is not mentioned. The document states "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

• Not detailed. While "algorithm performance tests" are mentioned, detailed results or methodology for a standalone performance study (e.g., specific sensitivity/specificity values for arrhythmia detection on a labeled dataset) are not provided. The algorithm is presented as providing a "computer-generated analysis" that "must be confirmed by a physician," implying it's not intended for standalone diagnostic use.

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

• Not provided.

8. The sample size for the training set

• Not provided.

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

• Not provided.

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