Search Results

The Hewlett-Packard Viridia Component Monitoring System is intended for use in monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.

The modification is a software based change that combines software in the HP Clinical Monitoring System product line (M1175A, M1176A and M1177A, M100B/M1002B ECG/RESP) with the software in the HP Component Transport System Viridia, (M1205A), the devices are to be known collectively as the HP Viridia Component Monitoring System. The combination system will allow for shared future functionality capabilities in HP patient monitoring systems.

The provided text is a 510(k) summary for the Hewlett-Packard Viridia Component Monitoring System. It describes a software-based change that combines existing software within HP's clinical monitoring product lines. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than directly detailing a study that proves the device meets specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text. The document does not describe a clinical performance study with specific acceptance criteria that the device was tested against.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document focuses on showing substantial equivalence based on intended use, technological characteristics, and software changes rather than a new performance study with benchmarked acceptance criteria.

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

Not available in the provided text. No information is given about a test set or its data provenance, as a dedicated performance study is not described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not available in the provided text. Since no test set or ground truth establishment is described, this information is absent.

4. Adjudication Method for the Test Set

Not available in the provided text. No adjudication method is mentioned as a specific test set is not detailed.

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

Not available in the provided text. The document does not mention any MRMC study or the effect size of human readers improving with AI assistance. The device in question is a patient monitoring system, not primarily an AI-driven diagnostic tool in the sense of image interpretation.

6. Standalone (Algorithm Only) Performance Study

Not available in the provided text. While the change is software-based, the document doesn't detail a standalone performance study of the algorithm in isolation. It describes the integration of existing software components.

7. Type of Ground Truth Used

Not available in the provided text. Since no specific performance study is detailed, no information on the type of ground truth used is provided.

8. Sample Size for the Training Set

Not available in the provided text. No training set is mentioned, as the submission describes combining existing software from legally marketed predicate devices, implying prior validation rather than de-novo algorithm training for this specific submission.

9. How the Ground Truth for the Training Set Was Established

Not available in the provided text. As no training set is discussed, information on ground truth establishment for it is also absent.

In summary, the provided 510(k) notification focuses on the regulatory pathway of substantial equivalence for a software-based combination of existing monitoring systems. It does not contain the detailed clinical study information typically found when a new device's performance against specific acceptance criteria is being proven.

Ask a specific question about this device