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The PMP4 Medical Web Center is a Software application intended for supporting remote monitoring of Electrocardiographic (ECG), Spirometric, Fetal/Maternal, Blood Pressure, Heart Rate, Blood Glucose, Blood Oxygen Saturation, Body Weight and optionally other patients' vital signs and parameters. The data is received from transducers/monitors, which are external to the system.

The Card Guard® PMP4 Medical Web Center is a medical communication system using the latest cellular technologies, a mobile device (e.g. PDA, Cellular Phone), and personal medical monitors. It allows the patient to monitor his health and interact with the physician from anywhere and at anytime. As a web-based application, all the data is accessed through a common internet browser. The PMP4 Medical Web Center provides round-the-clock monitoring services from any location for healthcare providers and patients. The Center generates and manages electronic medical files for each patient who can be accessed from any handheld or PC browser. Patients receive a secure personal web page to send, view and store their health measurements, physician diagnosis, and disease-specific health trends. Physicians receive a secure patient database to host patient's medical files and test results. The Center also features educational content and health tips specific to the subscribers' health condition. The Center enables receiving, storing, displaying, updating, printing and forwarding of patient health and other patient related data, (such as demographics, doctors, medical history, diagnoses, etc.). Each user has a unique access to the Center. The system enables the administrator to add users, set user permissions and link between users. After recording a test on PMP4 monitors, the measurement can be sent wirelessly to the PMP4 Center, and the healthcare provider is notified of new patient data. The PMP system can help patients improve compliance and clinical outcomes, improve disease management and may reduce unnecessary hospitalizations, and emergency room visits. The PMP4 medical line of products include a 1/12-lead ECG event monitor, Spirometer, Pulse Oximeter, and monitors for measuring Blood Pressure, and Blood Glucose. Other monitors, such as Body Fat, Heart Rate, Body Temperature, and Weight Scale are proposed as future options.

The provided document is a 510(k) summary for the Card Guard PMP4 Medical Web Center. It describes the system's intended use and substantial equivalence to a predicate device, but it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance evaluation results.

Summary of missing information:

• Acceptance Criteria and Reported Device Performance: Not mentioned.
• Sample size for test set and data provenance: Not mentioned.
• Number of experts and qualifications: Not mentioned.
• Adjudication method for test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm-only) performance: Not mentioned.
• Type of ground truth used: Not mentioned.
• Sample size for training set: Not mentioned.
• Ground truth establishment for training set: Not mentioned.

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