(127 days)
The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with EASI™ ST segment Monitoring is indicated for: Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the
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™ capability is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.
The provided text is a 510(k) summary for the Hewlett-Packard Viridia Component Monitoring System with EASI™ ST Segment measurement. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a novel device. As such, much of the requested information regarding detailed study design, ground truth establishment, expert involvement, and sample sizes for training/test sets is not explicitly present in the provided document.
However, I can extract what is available and indicate where information is missing based on the document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study comparing the new device against such criteria. Instead, it relies on the concept of "substantial equivalence" to a predicate device, implying that its performance is comparable.
| Acceptance Criteria (Not Explicitly Stated for this 510(k)) | Reported Device Performance (Implied from Substantial Equivalence) |
|---|---|
| (Specific quantitative thresholds for ST segment measurement accuracy, sensitivity, specificity, etc., are not provided in the document) | The device's measurement technology and transmission of ECG signals are "similar" and "essentially the same" as legally marketed predicate devices. This implies that the performance is considered equivalent to those predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The 510(k) focuses on the technological equivalence and intended use rather than a detailed clinical validation study with a specified test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Since a detailed test set and ground truth establishment methodology are not described, the involvement of experts for this purpose is also absent from the summary.
4. Adjudication Method for the Test Set
This information is not provided in the document. Without a described test set and ground truth establishment, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not provided in the document. The submission is about a software enhancement to a monitoring system, not a diagnostic aid that would typically involve human readers. Therefore, an MRMC study is not relevant to this type of device and is not mentioned.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The document describes 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." It also states that "monitoring technology identical to that used in the predicates." This implies that the core ST segment measurement algorithm is either the same as or very similar to the predicate and that the focus is on the EASI™ electrode system's ability to provide signals for this existing algorithm. However, a standalone performance study with specific metrics for the algorithm itself (isolated from the entire monitoring system) is not explicitly detailed in this summary. The "study" here is more about demonstrating that the EASI™ technology can provide equivalent input for the existing ST segment measurement.
7. The Type of Ground Truth Used
Given the nature of the device (ST segment monitoring via ECG), the ground truth for such a device, if a study were conducted, would typically be a clinically accepted standard for ECG interpretation (e.g., expert cardiologists' readings of standard 12-lead ECGs obtained simultaneously, or sometimes correlational studies with other diagnostic tests). However, the document does not explicitly state the type of ground truth used for any performance evaluation, as it relies on substantial equivalence.
8. The Sample Size for the Training Set
This information is not provided in the document. As the device is an enhancement to an existing system, and the technology is described as "identical to that used in the predicates," it's possible that no "training set" in the context of a new machine learning algorithm was used. If a training set was used for the original development of the ST segment algorithm, that information is not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, for the reasons outlined in point 8.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.