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1. The TruVue™ System is intended for use by 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, such as the BMS Century Holter system to provide Holter style reports

The TruVue™ system is a continuous ECG monitor and Arrhythmia detector. The system is comprised of a body worn sensor that collects, stores and transmits 2 channels of ECG, a handheld communications device that transmits the ECG to an attended monitoring center and analysis software that continuously analyzes the ECG signal for arrhythmia.

The sensor communicates with the handheld over a Bluetooth link, the handheld communicates with the data center over the cellular telephony network or a land line telephony network. Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician.

The provided 510(k) summary for the TruVue™ System (K100155) does not contain a detailed study with acceptance criteria and reported device performance metrics in the way modern AI/ML device submissions typically do.

This submission from 2010 focuses heavily on substantial equivalence to predicate devices. The "performance validation" mentioned in section 7 ("Conclusions") is likely referring to the device's adherence to relevant performance standards like AAMI EC 38 and ANSVAAMI-EC 57, rather than a specific clinical study with granular performance metrics for arrhythmia detection that would be found in a standalone algorithm study.

Therefore, many of the requested fields cannot be directly extracted from this document. I will fill in what can be inferred or directly stated, and clearly mark what information is not present.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. (The document mentions the device transmits data to a monitoring center, but doesn't detail any specific dataset used for validation beyond adherence to standards).
• Retrospective or Prospective: Not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states "Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician," but doesn't describe expert review for ground truth establishment in a testing context.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not indicated. This type of study is more common for imaging AI devices. The TruVue™ System is an "Arrhythmia Detector and Alarm," and its "analysis algorithm" would likely be evaluated in a standalone performance study rather than a reader study in the context of this 2010 submission.
• Effect Size: Not applicable/Not reported.

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

• Standalone Study: The document implies a standalone algorithm, as it describes "analysis software that continuously analyzes the ECG signal for arrhythmia." However, it does not present specific data from a standalone performance study in terms of metrics like sensitivity, specificity, or PPV/NPV for various arrhythmias. Instead, it relies on compliance with standards (AAMI EC 38, ANSVAAMI-EC 57) for performance validation.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated. For a device like this, ground truth would typically be established through expert cardiological review of the full disclosure ECG data (potentially with additional clinical information), but the document does not detail this.

8. The sample size for the training set

• Training Set Sample Size: Not specified. The document describes a "Proprietary / Server side" algorithm but provides no details about its development or training.

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

• Ground Truth Establishment (Training Set): Not specified.

Summary Limitations:

This 510(k) summary provides very limited information regarding detailed performance studies with acceptance criteria, ground truth, and statistical metrics. This is characteristic of older 510(k) submissions, particularly for devices seeking substantial equivalence where performance is often demonstrated through adherence to recognized standards and comparison to previously cleared devices rather than extensive clinical performance trials with granular data. The focus is on demonstrating that the device is "as safe and effective as its predicates."

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The Century Series Holter Scanner System, Model C3000/C2000/C1000 is intended for the replay and analysis of ECG data pre-recorded on compatible cassette tape or digital Holter recorders and is indicated for:

• Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
• To assess risk for future cardiac events in patients without symptoms from arrhythmia who have bee diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
• Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
• ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.

The Century Series Holter Scanner System, Model C3000/C2000/C1000 is a Holter ECG analysis software application that allows evaluation of Holter recordings obtained using solid-state digital Holter recorders or standard cassette tape Holter recorders. It is the successor to the Century Color Trace Holter Analyzer, 510(k) # K884152. The analysis is based on the WPI algorithm, as was the Century Color Trace. The unit features arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and determination of beat types, in both an automatic and interactive mode.

The provided 510(k) summary (K024323) for the Century Series™ Holter Scanner System (Models C3000/C2000/C1000) does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Century Color Trace, K884152). This means the submission argues that the new device performs similarly to a previously cleared device, rather than providing a detailed study against specific performance metrics for the new device.

Here's an breakdown of why the requested information cannot be fully provided from the given text:

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

   • Acceptance Criteria: Not explicitly stated in the document. The submission relies on the predicate device's performance as the benchmark for substantial equivalence.
   • Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are reported for the new device in the provided text. The "Table of Comparison" primarily lists features and technical specifications, not performance outcomes.

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

   • No test set is mentioned, nor are details about data 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):

   • No test set is mentioned, therefore no information on experts for ground truth is provided.

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

   • No test set is mentioned, therefore no adjudication method is described.

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 MRMC study is mentioned. This device is an "ECG analysis software" and the submission focuses on automated analysis and interaction with the software, not human-in-the-loop performance improvement with AI.

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

   • While the device is an "ECG analysis software application" that performs "arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and determination of beat types, in both an automatic and interactive mode," the document does not describe a standalone performance study with specific metrics for the algorithm's performance without human interaction. It implies an automated analysis capability ("Automated Analysis: Yes"), but doesn't quantify its standalone accuracy.

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

   • Not mentioned, as no specific performance study is detailed.

8. The sample size for the training set:

   • Not mentioned, as no AI/machine learning training details are provided. It states the analysis is "based on the WPI algorithm," which implies an existing established algorithm rather than a newly trained one for this submission.

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

   • Not mentioned.

Summary of what is present:

• Device Description: The Century Series Holter Scanner System is an ECG analysis software application for evaluating Holter recordings. It features arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and beat type determination. It is based on the WPI algorithm, similar to its predicate device.
• Intended Use: For replay and analysis of ECG data from Holter recorders for cardiac evaluation of heart rate/rhythm, assessing risk for future cardiac events, assessing drug response, and ST segment analysis in specific patient populations.
• Predicate Device: Century Color Trace (K884152).
• Key Argument for Substantial Equivalence: The primary differences (microprocessor speed, OS, addition of HRV-Time Domain and QT analysis) "do not, however, represent a change of the intended use(s) and indications... or alter the fundamental technology of the Holter analysis." This statement is the core of their "proof" for equivalence, rather than a detailed performance study against acceptance criteria.

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