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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.
2. MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients.
3. The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III antiarrhythmic drugs.

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

The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle with accessories. The body worn Sensor Pod acquires, stores and forwards electrocardiogram (ECG) data from Leads in a Wired Lead-Set or in a Patch to the Gateway using a 2.4GHz BLE wireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® Gateway Mobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwards the ECG signal data to the MoMe Software Platform (K152491) via a wireless cellular link.

The MoMe ARC® communicates with the MoMe Software Platform (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe Device Communications Protocol. The MoMe Software System (K152491) 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 an optional patient triggered event feature that allows for manual selection and recording of patient symptoms, if and when desired.

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

The MoMe ARC®:

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

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for the MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device's performance met "predefined acceptance criteria" for sensitivity and positive predictivity, and provided a "mean absolute error" for heart-rate accuracy. However, the precise numerical values for the acceptance criteria thresholds themselves for sensitivity and positive predictivity are not explicitly stated in the provided text. We only have the reported performance.

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

• Sample Size: 87 adult subjects.
  • Inpatient cohort: 75 subjects
  • Outpatient cohort: 12 subjects
• Data Provenance:
  • Country of origin: United States ("single U.S. clinic").
  • Retrospective or Prospective: Prospectively collected.

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

• Number of Experts: Not explicitly stated as a number of individual experts. However, the ground truth was established by "Certified Cardiac Technicians (CCTs)". This implies multiple CCTs were likely involved in adjudicating the data.
• Qualifications of Experts: Certified Cardiac Technicians (CCTs). The document doesn't provide further detail on their experience level (e.g., years of experience).

4. Adjudication Method for the Test Set

• The data from all 87 subjects were "adjudicated by Certified Cardiac Technicians (CCTs) using Holter software, with beat locations, morphologies, and arrhythmia annotations serving as the reference standard."
• This suggests a single-reader adjudication process per case by a CCT to establish the ground truth, rather than a multi-reader consensus method like 2+1 or 3+1.

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 comparative effectiveness study was not reported. The study focused on the performance of the "Software Platform's sensitivity and positive predictivity" against a CCT reference, which is a standalone performance evaluation, not a human-in-the-loop study comparing human performance with and without AI assistance.

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

• Yes, a standalone performance evaluation was done. The "Software Platform's sensitivity and positive predictivity were calculated using ANSI/AMI/IEC EC57:2012 methods" against the CCT-adjudicated reference standard. This directly assesses the algorithm's performance.

7. The Type of Ground Truth Used

• The ground truth was established through "expert consensus" in the form of "adjudication by Certified Cardiac Technicians (CCTs) using Holter software, with beat locations, morphologies, and arrhythmia annotations serving as the reference standard." This is a form of expert consensus based on established clinical procedures (Holter analysis).

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only describes the clinical validation study (test set).

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

• The document does not state how the ground truth for the training set was established. It only describes the ground truth process for the independent test set used for performance validation.

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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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The MoMe® Software Platform is intended to be used for patients 22 years and older that have one or more of the following conditions:

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia

2. Patients with dizziness or lightheadedness.

3. Patients with palpitations.

4. Patients with syncope of unknown etiology.

5. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.

6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.

7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.

8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.

9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

The MoMe® Software Platform is contraindicated for:

1. Patients with potentially life threatening arrhythmias who require in-patient monitoring.

2. Patients who the attending physician thinks should be hospitalized.

3. Patients with implanted pacemakers. ICDs, neurostimulators and/or body worn medical devices such as insulin pumps.

MoMe® Software Platform is a cloud based arrhythmia analysis and ECG management software system used for Arrhythmia Detection and Monitoring. The system receives ECG and optional activity data from single or multiple lead continuous ECG recorders over a local network or internet connection. This data is evaluated by an arrhythmia analysis algorithm when received, and any detected arrhythmias that the physician has elected to review are presented for physician review. The system provides information on arrhythmias detected, arrhythmia durations, activity levels, heart rate variability and patient reported symptoms. All full disclosure data, events and reports covering the patient monitoring period can be reviewed by a physician through web and mobile applications with secure, role-based authentication. The applications collectively provide for patient data entry, event review, creation of reports, and association of devices with patient records.

The MoMe® Software Platform supports three cardiac monitoring modes:

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

MoMe® Software Platform processes recorded cardiac monitoring data from ECG Devices that adhere to the data formats and communications protocol described in the Device Communications Protocol (10094), and may be reviewed at anytime, anywhere by a physician using a standard browser with web access. Data may also be exported for additional review and reporting if desired.

MoMe® Software Platform is intended to provide information that assists the physician, along with patient symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.

MoMe® Software Platform 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 MoMe® Software Platform is an arrhythmia detection and monitoring software system. The acceptance criteria and the study proving it meets these criteria are outlined below:

1. Acceptance Criteria and Reported Device Performance

The MoMe® Software Platform was tested against industry standards for arrhythmia detection. The document indicates compliance with:

• ANSI/AAMI/IEC 606012-47:2012: Medical electrical equipment— Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
• ANSI/AAMI EC57:2012: Testing and reporting performance results of cardiac arrhythmia and ST segment measurement algorithms.

The specific performance metrics and their corresponding acceptance criteria are not explicitly detailed in the provided text, but the general statement is made that "Software verification and validation reports demonstrate the MoMe® Software Platform meets its intended use and design requirements."

Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "standard industry practices" and conformance with the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003) for algorithm testing.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set or the adjudication method.

4. Adjudication Method

Not specified in the provided text.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI assistance. The submission focuses on the standalone performance of the software platform.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states, "The MoMe® Software Platform Arrhythmia detection algorithm has been testing using standard industry practices and in accordance with the FDA Guidance 'Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm' released October 2003." This confirms the algorithm's performance was evaluated independently.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, given it's an arrhythmia detection system tested against standard industry practices, it's highly probable the ground truth was established through expert cardiologist interpretations of ECG recordings.

8. Training Set Sample Size

The sample size for the training set is not specified in the provided text.

9. Ground Truth Establishment for Training Set

The method for establishing ground truth for the training set is not described in the provided text.

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The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for:

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
2. Patients with dizziness or lightheadedness.
3. Patients with palpitations.
4. Patients with syncope of unknown etiology.
5. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.
9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

The MoMeTM Continuous ECG Monitor and Arrhythmia Detector System (abbreviated to MoMe System in this section) is a remote physiologic monitoring system that detects non-life threatening arrhythmias. The MoMeTM System incorporates a front end device worn by the patient that collects and streams ECG, heart rate and motion (activity) to a dedicated smartphone that continuously transmits the data to remote server. The system then uses proprietary algorithms to continually analyze data and provide reports of detected events. These reports can be accessed anytime, anywhere by a physician using a standard browser or a MoMe iPad App.

The provided text includes a 510(k) Summary for the MoMe™ Continuous ECG Monitor and Arrhythmia Detector System, which details its performance data and the studies conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003) for the acceptance criteria, and states that the device was tested using "standard industry practices and in accordance" with this guidance. However, the specific acceptance criteria (e.g., minimum sensitivity, specificity for certain arrhythmia types) and corresponding reported device performance values are not explicitly detailed in the provided text. The document broadly states: "The MoMe Arrhythmia detection algorithm has been tested using standard industry practices and in accordance with the FDA Guidance 'Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm', released October 2003. The Software Verification and Validation reports, MoMe System Verification and Validation report, Algorithm validation report, Transceiver Verification and Validation report, Usability test reports all demonstrate that the MoMe System meets its intended use and design input requirements."

Without the specific performance targets from the FDA Guidance and the numeric results from the MoMe system's validation reports, a detailed table cannot be created.

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

The document mentions "Algorithm validation report" but does not specify the sample size of the test set or the data provenance (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:

This information is not provided in the given text.

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

This information is not provided in the given text.

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 provided in the given text. The study mentioned is a "standalone" algorithm validation, not a comparative effectiveness study involving human readers with and without AI assistance.

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

Yes, a standalone algorithm validation was done. The document states: "The MoMe Arrhythmia detection algorithm has been tested..." and refers to an "Algorithm validation report." This implies testing the algorithm's performance independent of human intervention.

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

The document does not explicitly state the type of ground truth used for the algorithm validation. For arrhythmia detection algorithms, ground truth is typically established by expert cardiologists reviewing the ECG tracings.

8. The sample size for the training set:

The document does not specify the sample size for the training set.

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

The document does not specify how the ground truth for the training set was established.

Summary of available information regarding the study:

• Study Type: Algorithm validation, software verification and validation, system verification and validation, transceiver verification and validation, usability testing.
• Standards Followed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, ANSI/AAMI/ISO EC 57:1998/R(2008), ANSI/AAMI EC53:1995/(R)2008, ISO 10993 (various parts for biological evaluation).
• Compliance: The MoMe System complies with applicable clauses of IEC 60601 and was tested in accordance with the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003).

Missing Information (not found in the provided text):

• Specific quantitative acceptance criteria for arrhythmia detection (e.g., sensitivity, specificity, accuracy for different arrhythmia types).
• Specific quantitative reported performance metrics of the MoMe system against these criteria.
• Sample size of the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for ground truth.
• Details of any MRMC comparative effectiveness study or human reader improvement data.
• Type of ground truth explicitly defined (though likely expert review for ECGs).
• Sample size of the training set.
• Method for establishing ground truth for the training set.

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