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The PAM™3000 system is intended to measure heart rate and respiration rate in adult patients, in a general care hospital environment including, nursing homes The system monitors presence or absence of a patient in bed (bed exit) The system also times the length of continuous patient motion or absence of patient motion

The PAM™3000 System is intended for contact-less and wreless monitoring of bed occupancy, motion and heart and respiration rates of adult patients 11 healthcare facilities The system utilizes a hıghly sensitive UWB-based motion sensor to detect the motion of heart and thorax The system consists of a Bed Sensor Panel (BSP), placed under the patient's mattress, Repeater Base Stations (RBS) that are typically mounted around the hallways in facility, and the Central Computer Station (CCS) with plugged-in Central Base Station (CBS) The signal containing the patient's heart rate and respiration rate data, bed occupancy data, patient motion, and the alerts generated by system are displayed on a PC monitor using Wireless 2000's proprietary Graphic User Interface (GUI) software The Central Computer Station (CCS) is typically located at the nursing station

Here's the detailed breakdown of the acceptance criteria and study information for the Wireless2000 PAM™ 3000 device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "The PAM™3000 System underwent bench validation testing and clinical validation testing. The results of the testing indicate that the PAM™3000 performs according to its specifications and accurately detects respiration rate and heart rate of patients and patient presence in bed."

However, it does not provide specific quantitative acceptance criteria or the reported device performance in a table format. It mentions the measurement ranges for heart rate and respiration rate for the device's capabilities, but not as acceptance thresholds for the validation study.

Measurement Ranges:

2. Sample Sizes and Data Provenance

The provided text does not specify the sample size used for the test set or the training set. It also does not mention the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts and Qualifications

The provided text does not mention the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The provided text does not mention any adjudication method used for the test set.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. This device appears to be a standalone monitoring system, not one designed for human interpretation assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was done. The document states: "The results of the testing indicate that the PAM™3000 performs according to its specifications and accurately detects respiration rate and heart rate of patients and patient presence in bed." This refers to the device itself (the algorithm/system) directly detecting these parameters.

7. Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used. Given the nature of the device (heart rate, respiration rate, and bed occupancy), it is highly probable that the ground truth would have been established using reference medical devices (e.g., ECG for heart rate, capnography or a reference respiration monitor for respiration rate, and direct observation for bed occupancy/motion). However, this is an inference and not directly stated in the document.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

9. How Ground Truth for the Training Set was Established

The provided text does not state how the ground truth for the training set was established.

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