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The CardioBelt™ is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.

The Monebo CardioBelt™ is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver. The CardioBelt™ electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The CardioBelt™ is designed to be used without electrolytic gels and without adhesives on unprepared skin; that is without the requirements for shaving, abrading, or other skin preparation. The CardioBelt transmits ECG information to a compatible Bluetooth enabled device. The CardioBelt contains a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics for the Monebo CardioBelt™ Electrode Belt. Instead, it offers a summary of verification and validation testing, and mentions a comparative study, but lacks the granular data requested in the prompt.

However, based on the information provided, here's what can be extracted and inferred:

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

The document mentions that the device "meets the generally accepted safety testing requirements for an EC38 1.2 c type 3 ECG device" and "meets the clinical requirements." It also states the device was found to be "easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's."

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

The text mentions "a study at Bad Oeynhausen Herzzentrum hospital in Germany" that "compared the performance of the single lead Cardiobelt to a 12 lead ECG (Gold Standard)."

• Sample Size: Not specified.
• Data Provenance: Prospective (implied by "a study"), from Bad Oeynhausen Herzzentrum hospital in Germany.

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

The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical study. It only mentions the comparison to "a 12 lead ECG (Gold Standard)," implying that the interpretation of the 12-lead ECG by clinicians would serve as the ground truth.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the ground truth or the device's output.

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

The document describes a comparative study between the CardioBelt and a 12-lead ECG. However, this was a comparison of the device's performance against a gold standard, not a multi-reader multi-case study evaluating the improvement of human readers with AI assistance versus without. The CardioBelt is described as a "single lead acquisition system that transmits ECG data via Bluetooth™ communication to a generic Bluetooth™ recording and/or analysis system. The device does not perform ECG analysis." Therefore, it's not an AI-assisted device in the context of interpretation.

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

This is not directly applicable as the CardioBelt is an electrode system for acquiring ECG data, not an algorithm for analyzing it. The device itself is "algorithm-only" in the sense that it doesn't involve human interpretation for its primary function (data acquisition). However, the results of the acquired ECG data would then be interpreted by a physician. The statement "The device does not perform ECG analysis" reinforces that it's a data acquisition tool, not an analytical one.

7. The type of ground truth used

For the clinical study, the ground truth was established by comparison to a 12-lead ECG (Gold Standard). This implies expert interpretation of the 12-lead ECG to determine "normal or pathologic ECG's."

8. The sample size for the training set

The document does not mention any "training set." This device is an electrode belt that acquires physiological signals, not an AI/machine learning algorithm requiring a separate training phase. The described testing (bench and clinical) is for verification and validation of the hardware and its ability to acquire data reliably.

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

Not applicable, as there is no mention of a training set for this device.

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The Automatic Analysis and Interpretation Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Hotter, Event Monitor, 12 lead ambulatory or resting ECG devices, or other similar devices when assessment of the rhythm is necessary. The Automatic Analysis and Interpretation Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Automatic Analysis and Interpretation Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to sixteen(16) leads of captured data. The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

The Monebo Automated ECG Analysis and Interpretation Software Library is an "object library". An object library is a collection of callable functions that have been complied (or assembled) into machine code or IDL code of the computer on which they execute. The Monebo Automated ECG Analysis and Interpretation Software Library consists of a basic application for viewing, analyzing and annotating ECG data, and a callable object library built on the Microsoft .Net framework. An application software program can be written to invoke some or all of the functions in an object library. The Monebo Automated ECG Analysis and Interpretation Software Library provides ECG signal processing, QRS detection and measurement of duration, QRS feature extraction, classification of Normal and Ventricular Ectopic beats, heart rate measurement, measurement of PR and QT intervals, and rhythm interpretation for up to 16 leads of captured ECG data. The library can be accessed through an Application Program Interface (API) as a callable function. This allows the library to be used as an accessory to an ECG management application or as a stand-alone product. Monebo will compile the Monebo Automated ECG Analysis and Interpretation Software Library specified by an ECG device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into application software for their ECG analysis.

Here's a summary of the acceptance criteria and study details for the Monebo Automated ECG Analysis and Interpretation Software Library, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the results achieved in comparison to established benchmarks (AHA, MIT-BIH, CSE databases) for QRS detection, ventricular ectopic beat (VEB) detection, heart rate, and various arrhythmia statements. The document doesn't explicitly state pass/fail thresholds for each metric but reports the device's performance against these recognized standards.

Bench Test Results (per ANSI/AAMI EC 57):

Bench Test Results (per IEC 60601-2-51 for CSE Database):
The table provided for the CSE database is incomplete and contains corrupted text, making it impossible to extract specific criteria and performance values for measurement accuracy (mean difference and standard deviation).

Arrhythmia Detection Accuracy (Overall MIT DB):

Accuracy of Specific Arrhythmia Statements (MIT DB):

(CU DB - Ventricular Flutter):

Rhythm Accuracy (250 Annotated ECG Strips):

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

The document indicates the following for test sets:

• AHA, MIT-BIH, NST (likely part of MIT-BIH): Standard databases used for benchmarking. The specific number of records/patients from these databases is not provided, but these are well-known, publicly available, and diverse datasets.
  • Provenance: These are international, publicly available retrospective databases.
• CSE Database: Standard database used for benchmarking.
  • Provenance: This is an international, publicly available retrospective database.
• MIT DB Arrhythmia Statements: Specific sections provide sensitivity, specificity, and predictive values for various arrhythmias using the MIT-BIH database.
  • Provenance: International, publicly available retrospective database.
• 250 Annotated ECG Strips: Used for detailed rhythm classification metrics.
  • Provenance: "renorded by various event recorders". The country of origin is not specified, nor is whether it's retrospective or prospective, but it implies a collection of real-world patient data.

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

• The document does not specify the number or qualifications of experts used to establish the ground truth for any of the databases (AHA, MIT-BIH, CSE, or the 250 ECG strips). It relies on the pre-established annotations of these benchmark databases, which are generally considered expert-annotated.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test sets. It relies on the existing annotations within the standard databases.

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

• No MRMC comparative effectiveness study is mentioned in the document. The study evaluates the standalone performance of the algorithm against established ground truths, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The entire "Test Results" section (K062282, pg 2 and 3) details the performance of the "Monebo Automated ECG Analysis and Interpretation Software Library" in identifying QRS complexes, VEBs, and various arrhythmias against established benchmark databases (AHA, MIT-BIH, CSE) and a set of 250 annotated ECG strips. This directly measures the algorithm's performance without human intervention.

7. Type of Ground Truth Used

• The ground truth used for the studies appears to be expert consensus annotations as provided within the standard benchmark databases (AHA, MIT-BIH, CSE) and the "250 annotated ECG strips." These databases are conventionally annotated by electrophysiologists or cardiologists based on visual inspection and established diagnostic criteria. The document does not mention pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

• The document does not specify the sample size or details about any training set used for the algorithm. The provided information focuses entirely on the validation and testing of the final algorithm's performance on external datasets.

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

• Since no information about a training set is provided, there is no detail on how its ground truth was established.

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The Automatic Arrhythmia Detection Software Library is intended for use by qualified medical professionals for assessing historic ambulatory ECG data. The product allows downloading and analyzing data recorded in compatible format by Holter or Event monitoring devices. The Automatic Arrhythmia Detection Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, and QRS feature extraction.

The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

The Monebo Automatic Arrhythmia Detection Software Library is an "object library". An object library is a collection of callable functions that have been complied (or assembled) into machine code or IDL code of the computer on which they execute. The Automatic Arrhythmia Detection Software Library consists of a basic application for viewing, analyzing and annotating ECG data and callable object library built on the Microsoft .Net framework. An application software program can be written to invoke some or all of the functions in an object library.

The Monebo Automatic Arrhythmia Detection Software Library provides ECG signal processing, QRS detection, QRS feature extraction, and ventricular ectopic beat detection for up to 12 leads of captured ECG data.

Monebo will compile the Automatic Arrhythmia Detection Software Library specified by an ECG analysis device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into application software for their ECG analysis. The device manufacturer will be required to submit a 510k with the specific requirements for that device.

Here's an analysis of the acceptance criteria and study data for the Monebo Automatic Arrhythmia Detection Software Library, Version 1:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in terms of specific thresholds the device needed to meet to be considered effective. However, the performance metrics observed in the bench tests are presented, and by comparing these to industry standards or expectations for such devices, we can infer what might have been considered "acceptable." Given the device received 510(k) clearance, the reported performance was deemed sufficient by the FDA for substantial equivalence.

Explanation of Metrics:

• QRS Se (Sensitivity): The percentage of actual QRS complexes correctly identified by the software.
• QRS +P (Positive Predictivity): The percentage of QRS detections made by the software that were actually QRS complexes.
• VEB Se (Ventricular Ectopic Beat Sensitivity): The percentage of actual Ventricular Ectopic Beats correctly identified by the software.
• VEB +P (Ventricular Ectopic Beat Positive Predictivity): The percentage of Ventricular Ectopic Beat detections made by the software that were actually Ventricular Ectopic Beats.

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

• Sample Size: The document refers to "AHA and MIT-BIH databases" and an "NST database." These are well-known, publicly available databases of ECG recordings, often used for benchmarking arrhythmia detection algorithms. The specific number of recordings or patients from each database used for testing is not explicitly stated in this summary.
• Data Provenance:
  • Country of Origin: Not specified for the AHA and MIT-BIH databases, but they are recognized international standards. The NST database's origin is also not specified.
  • Retrospective or Prospective: These databases typically consist of retrospective ECG recordings collected over time for research and testing purposes.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the AHA, MIT-BIH, or NST databases. However, it's widely known that these databases were meticulously annotated by multiple cardiologists and electrophysiologists using established criteria to create the "gold standard" annotations.

4. Adjudication Method for the Test Set:

The document does not explicitly state the adjudication method used for the creation of the ground truth in the AHA, MIT-BIH, or NST databases. However, for such widely accepted benchmark databases, a rigorous consensus-based adjudication process involving multiple experts is standard practice to establish the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, the provided document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The study presented is a standalone performance evaluation of the algorithm against existing, expert-annotated databases. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

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

Yes, a standalone performance study was done. The "Test Results" section explicitly states "The bench test results of the software using AHA and MIT-BIH databases are show in the table below." This indicates that the algorithm's performance was evaluated purely on its own, without a human in the loop, against the ground truth annotations in these databases.

7. The Type of Ground Truth Used:

The type of ground truth used was expert consensus annotations. The AHA and MIT-BIH databases, in particular, are renowned for having their ECG recordings meticulously annotated by multiple expert cardiologists and electrophysiologists, creating a "gold standard" for various cardiac events, including QRS complexes and ventricular ectopic beats.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set for the Monebo Automatic Arrhythmia Detection Software Library. It only discusses the test results on the specified databases.

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

Since the document does not mention the training set or its sample size, it also does not provide information on how the ground truth for the training set was established.

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