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MoMe® ARC is indicated for:

1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
3. 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)
4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.

MoMe® ARC is contraindicated for:

1. MoMe® ARC is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
   Note: MoMe® ARC does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link.

The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway. The user interface is composed of a mechanical button, display with touch screen, vibrator, and a speaker on the Gateway and a vibrator and LED on the Sensor.

The MoMe® ARC communicates with the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. The MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.

Once activated and operating normally the system requires no patient intervention to capture or analyze data. However, the MoMe® ARC has a patient triggered Event feature that allows for selection and recording of their symptoms if desired.

The device is intended for use under prescription only for monitoring patients with suspected cardiac arrhythmias.

MoMe® ARC:

• Is non-invasive and poses no significant safety issues
• . Uses existing electrode and ECG technology
• ls used in an adjunctive fashion, where physicians also use patient symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.

MoMe® ARC is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.

The intended use of the MoMe® ARC is for ECG reporting and arrhythmia detection in patients with non-life threatening arrhythmias.

This document only discusses the substantial equivalence of the MoMe® ARC device to its predicate device, MoMe® Kardia (K160064), based on non-clinical performance testing. It explicitly states that "No clinical tests were required to demonstrate substantial equivalence." Therefore, the document does not contain information about acceptance criteria for device performance based on clinical outcomes or a study proving the device meets such criteria through human-in-the-loop or standalone algorithm performance metrics.

However, it does address the performance testing against non-clinical standards and the equivalence of its features to the predicate device. I can extract information related to the device's technical specifications and the testing conducted to ensure it meets general safety and performance standards for ECG monitoring devices.

Here's what can be extracted based on the provided text, focusing on the available performance and testing information where applicable, and explicitly stating what information is not present regarding clinical performance:

The MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System's acceptance criteria and proven performance, as described in this 510(k) summary, are primarily focused on non-clinical performance testing and substantial equivalence to a predicate device, rather than a clinical study demonstrating specific performance metrics for arrhythmia detection by the device's algorithm or human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria for arrhythmia detection performance (e.g., sensitivity, specificity, accuracy for various arrhythmias) and reported device performance from a clinical study. Instead, the performance testing described is against general medical device and ECG standards.

Note: The document explicitly states, "No clinical tests were required to demonstrate substantial equivalence." Therefore, there is no information on clinical performance metrics like sensitivity, specificity, or accuracy for arrhythmia detection in patients using the AI algorithm.

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

As no clinical efficacy study or specific test set for AI algorithm performance against clinical ground truth was conducted or reported for this 510(k), there is no information on sample size or data provenance (e.g., country of origin, retrospective/prospective) related to an AI performance test set. The non-clinical tests were conducted in a lab or testing facility setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical study evaluating the performance of the device's arrhythmia detection algorithm was conducted, there is no mention of experts being used to establish a ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Given the lack of a clinical test set for algorithmic performance, no adjudication method (e.g., 2+1, 3+1) is described.

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

No MRMC comparative effectiveness study was done or reported. The submission explicitly states, "No clinical tests were required to demonstrate substantial equivalence." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance. The device is intended to flag data for physician review, implying a human-in-the-loop process, but no study on the impact of this assistance is provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithmic performance study was done or reported in this document. The focus of the submission is on substantial equivalence based on non-clinical performance and the device's technical specifications.

7. Type of Ground Truth Used

For the technical performance of the device and its compliance with standards, the ground truth would be the defined parameters and specifications within the voluntary FDA recognized standards (e.g., IEC 60601-2-47 for ambulatory ECG systems). For the "Arrhythmia Detection Algorithm," it is noted as "Proprietary/Server Side" and "Identical" to the predicate, implying it relies on previously established and validated algorithms, but no details on their independent validation or the ground truth used for that validation are provided in this specific document.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for training the proprietary arrhythmia detection algorithm. This information is typically proprietary to the device manufacturer and not directly required for a 510(k) submission focused on substantial equivalence to a predicate, especially when no new clinical performance claims are being made for the algorithm's accuracy.

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

The document does not provide information on how the ground truth was established for the training set of the proprietary arrhythmia detection algorithm. Similar to the sample size, this is typically part of the internal development and validation of the algorithm, rather than a requirement for this type of FDA submission.

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MoMe® Kardia is intended to be used for:

1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.

2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)

3. 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)

4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.

5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.

MoMe® Kardia is contraindicated for:

1. MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias.

Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

MoMe® Kardia includes the wearable MoMe® Kardia Device that acquires and stores ECG and motion (accelerometer) data and transmits that data via cellular technology to the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. MoMe® Kardia requires no patient intervention to capture or analyze data however does provide a patient event trigger.

MoMe® Kardia supports three cardiac monitoring modes:

1 Holter
2 Event Monitoring
3 Mobile Cardiac Telemetry (MCT)

MoMe® Kardia:

• Is non-invasive and poses no significant safety issues ●
• Uses existing electrode and ECG technology ●
• ls used in an adjunctive fashion, where physicians also use patient ● symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.

MoMe Kardia is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.

This document is a 510(k) summary for the MoMe® Kardia Wireless Ambulatory ECG Monitoring and Detection System, comparing it to a predicate device (TruVue™ Wireless Ambulatory ECG Monitoring System). It does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics.

However, based on the information provided, we can infer some aspects relevant to your request.

Missing Information:

• Specific acceptance criteria with numerical targets for device performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection).
• Reported device performance against these numerical acceptance criteria.
• Details of the study that proves the device meets specific acceptance criteria. The document states "The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements," but does not elaborate on these test reports or their results.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone (algorithm-only) performance details.
• Sample size for the training set.
• How ground truth for the training set was established.

Information that can be extracted or inferred:

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

This information is not explicitly provided in the document. The document states that "The MoMe® Kardia submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released on October 2003. The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements." However, the specific acceptance criteria and the reported performance values that demonstrate this conformance are not listed.

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

This information is not explicitly provided in the document.

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)

This information is not explicitly provided in the document.

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

This information is not explicitly provided in the document.

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

This information is not explicitly provided in the document. The device "flags for physician review" but there's no mention of a comparative effectiveness study with human readers.

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

The document mentions "proprietary algorithms for analysis" that flag data for physician review, suggesting a standalone algorithmic component. However, specific standalone performance metrics are not provided.

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

The document states, "Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician." This implies that the ultimate "ground truth" for clinical diagnosis would be physician interpretation. However, how the ground truth for the performance testing of the device's arrhythmia detection algorithm was established is not explicitly stated. It can be inferred that it would be based on expert review of ECG data, but the specifics are absent.

8. The sample size for the training set

This information is not explicitly provided in the document. The document mentions "proprietary algorithms for analysis" but does not detail their development or training.

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

This information is not explicitly provided in the document.

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