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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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