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510(k) Data Aggregation
(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.
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(156 days)
The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with EASI-ECG Option is indicated for:
- 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.
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.
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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(84 days)
The HP M1001B/M1002B ECG Plug-in Modules together with the Patient Monitor M1175A/M1176A are indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:
- Can measure and display multiple physiological parameters and waves' a) of one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets.
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- List of supported measurements
- ECG (a)
- Respiration (b)
The M1001B ECG and M1002B ECG/Respiration Modules are intended for monitoring, recording, and alarming of ECG and respiration for adult, pediatric, and neonatal patients. Existing hardware and software of the M1001B ECG and M1002B ECG/Respiration plug-in modules (which were originally cleared together with CMS under K882609) were modified. The CMS hardware and CMS software modules are unchanged. The modified M1001B ECG and M1002B ECG/Respiration plug-in modules were fully validated (including regression testing).
This document is a 510(k) summary for the M1001B ECG and M1002B ECG/Respiration Modules. It describes the intended use and states that the devices were fully validated, including regression testing, after modifications to their hardware and software. It also claims substantial equivalence to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, specific device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications. The document focuses on regulatory approval and substantial equivalence rather than a detailed performance study.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The information you're asking for is not present in the provided text.
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