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Assessment of symptoms that may be related to rhythm disturbances of the heart: patients with palpitations, the evaluation of arrhythmia's in adult and pediatric patients.
Assessment of risk in patients with or without symptoms of arrhythmia.
Assessment of efficacy of antiarrhythmic therapy.
Assessment of pacemaker function.
Assessment of symptomatic or asymptomatic patients to evaluate for ischemic heart disease.
Assessment is indicated for single-hospital environment.

Device Description

The new device consists of a software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI electrode system. The EASI option is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.

AI/ML Overview

This 510(k) summary (K990476) describes a software enhancement to the Hewlett-Packard Viridia Component Monitoring System (CMS) and Viridia 24/26 Rev. K, adding an EASI-ECG Option. This option allows the system to derive a 12-lead electrocardiogram from a 5-lead EASI electrode system. The submission focuses on substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria for the EASI-ECG option itself.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria for the EASI-ECG option's performance (e.g., accuracy of derived 12-lead ECG compared to standard 12-lead ECG) are mentioned. The submission focuses on equivalence to predicate devices for the overall system's function and intended use. Therefore, a table for this specific information cannot be generated from the provided text.

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

Not applicable. The submission does not describe a clinical study of the EASI-ECG option proving its performance against specific acceptance criteria. The focus is on substantial equivalence.

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

Not applicable, as no performance study is detailed.

4. Adjudication Method

Not applicable, as no performance study is detailed.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on the functionality of the EASI-ECG option and its equivalence to predicate devices.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study for the EASI-ECG algorithm is not described. The document discusses a "software enhancement enabling the CMS system to accommodate an electrode placement pattern," implying a feature integration rather than a standalone algorithm performance evaluation.

7. Type of Ground Truth Used

Not applicable, as no performance study is detailed with a defined ground truth.

8. Sample Size for the Training Set

Not applicable. The submission describes a software enhancement, not a machine learning algorithm requiring a training set in the typical sense.

9. How Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary of Device Acceptance and Study Information (Based on Provided Text):

Feature/Criterion	Description (Based on K990476)
Acceptance Criteria	Not explicitly stated for the EASI-ECG option's performance. The basis for clearance is Substantial Equivalence to legally marketed predicate devices (Totemite EASI Lead System Cable K872781B and Zymed T8010 Telemetry Central Station Monitor K951370). The device's "technological characteristics are essentially the same as those of the legally marketed predicate devices" in terms of measurement technology and ECG signal transmission.
Device Performance Reported	No specific performance metrics (e.g., accuracy, sensitivity, specificity for derived 12-lead ECG) are reported in the provided summary. The device "accommodate[s] an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI electrode system."
Sample Size (Test Set)	Not applicable. No performance study with a test set is detailed. The submission focused on demonstrating substantial equivalence.
Data Provenance (Test Set)	Not applicable.
Number & Qualifications of Experts (Ground Truth - Test Set)	Not applicable.
Adjudication Method (Test Set)	Not applicable.
MRMC Comparative Effectiveness Study	No.
Effect Size (MRMC)	Not applicable.
Standalone Performance Study	No. The submission describes a software enhancement integrated into an existing system, cleared based on substantial equivalence.
Type of Ground Truth Used	Not applicable, as no performance study is detailed with specific ground truth data for the EASI-ECG derived leads. The substantial equivalence argument relies on the predicate devices' established safety and effectiveness.
Sample Size (Training Set)	Not applicable. This summary describes a software enhancement, not an AI/ML algorithm requiring a training set.
Ground Truth Establishment (Training Set)	Not applicable.

Conclusion from the Provided Text:

The K990476 submission for the Hewlett-Packard Viridia Component Monitoring System Rev.K with EASI-ECG Option does not present a performance study with explicit acceptance criteria, sample sizes, expert adjudication, or ground truth details for the EASI-ECG feature itself. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Totemite EASI Lead System Cable K872781B and Zymed T8010 Telemetry Central Station Monitor K951370) by asserting that the new device shares the same intended use and essentially similar technological characteristics (measurement technology and ECG signal transmission). The clearance is based on the premise that the EASI-ECG option is a software enhancement that allows an existing, cleared system to utilize a different electrode placement pattern to derive 12-lead ECG signals, implicitly assuming the derivation method's performance is acceptable within the context of the overall system's substantial equivalence to the predicate.

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