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The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure.

The ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations:

• ECG adult or neonatal
• Invasive and non-invasive blood pressure
• Respiration

The intended us of ProSim 6 and ProSim 8 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure, Non-invasive blood pressure and Cardiac output. Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional.

The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The devices provide the following physiological simulations:

• ECG adult or pediatric
• Invasive and non-invasive blood pressure
• Respiration
• Temperature
• Cardiac Output
• Fetal Simulation includes fetal, maternal ECG, & uterine contractions (ProSim 8 only)
  Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional

Fluke Biomedical's ProSim 4 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals and non-invasive blood pressure pulses. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

ProSim vital signs simulator consists of the following components:

1. Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2. Plastic iniection molded case parts.
3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
4. Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals, non-invasive blood pressure (NIBP) pressure pulses, temperature electrical signal, cardiac output electrical signal, and pulse oximetry SPO2 optical simulated light attenuation. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

ProSim vital signs simulator consists of the following components:
l ) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.

• 2) Plastic injection molded case parts.
• 3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
• 4. Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
• 5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 devices:

Executive Summary:

The Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 are vital signs simulators designed to test and verify the basic operation of patient monitoring devices. The devices function by providing electronic and pneumatic simulations of various physiological parameters. Extensive non-clinical bench testing was conducted to demonstrate that the ProSim devices perform within their published specifications and are substantially equivalent to their predicate devices (MedSim300B, Cufflink, and Index 2MF SPO2 for ProSim 6/8). Clinical testing was not performed, as the devices are intended for laboratory use for preventative maintenance and not for direct patient use or medical equipment calibration. The ground truth for the testing was the published specifications of the device itself, verified through laboratory measurements.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document provides a detailed comparison table between the ProSim devices and their predicate devices, indicating various performance characteristics. Since the acceptance criteria are essentially the published specifications and the study aims to show the device performs within those specifications, the "reported device performance" is implicitly that the device met these specifications, thus demonstrating substantial equivalence.

Below is a summarized table consolidating key features and their performance (or range of performance), with the acceptance criteria being that the ProSim meets or improves upon the predicate device's comparable specification or meets its own stated specifications if it's a new feature or different range.

ProSim 4 (compared to MedSim 300B and Cufflink)

ProSim 6 & 8 (compared to MedSim 300B, Index 2, and Cufflink)

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

• Sample Size: The document does not specify a numerical sample size for individual tests (e.g., how many measurements were taken for each parameter). It states that "Laboratory studies have been conducted with a representative patient monitor..." and "The ProSim [4/6/8] software has been successfully validated..." This implies that the testing involved a single representative device (the ProSim itself) undergoing various tests against its own specifications or in comparison to predicate devices.
• Data Provenance: The studies were non-clinical laboratory studies conducted by Fluke Biomedical. The location of the laboratory is likely the manufacturer's facility in the USA (Fluke Biomedical, Everett, WA, or Solon, OH). The data is retrospective in the sense that it's a summary of completed bench tests demonstrating performance.

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

• Number of Experts: The document does not specify the number of experts.
• Qualifications of Experts: The ground truth for this type of device, a vital signs simulator, is typically based on electrical and pneumatic engineering principles and established medical device standards for physiological parameter simulation (e.g., AAMI, IEC standards for ECG, BP). The testing would be performed by trained technicians or engineers proficient in metrology and test equipment, verifying the device's output against known, calibrated reference standards. While not explicitly stated, it's implied these are qualified personnel within Fluke Biomedical's R&D or Quality Assurance departments.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the traditional sense of human consensus for, say, image interpretation. The "adjudication" is based on objective measurement against defined performance specifications and comparison to predicate devices. The results are summarized by the manufacturer.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The ProSim devices are test equipment for patient monitors, not diagnostic tools. Their effectiveness is measured by their ability to accurately simulate physiological signals for verification and maintenance, not by improving human diagnostic performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, a standalone study was done. The entire "Non-Clinical Test Data" section describes rigorous bench testing of the ProSim devices themselves, which are algorithmic-driven instruments, to verify their performance within published specifications. The statement "The ProSim [4/6/8] software has been successfully validated to confirm the performance of the device" directly supports this. The device's function is standalone simulation; there isn't a "human-in-the-loop" once the simulation parameters are set.

7. The Type of Ground Truth Used:

• Engineering Specifications and Calibrated Reference Standards: The ground truth used is the device's own published specifications (e.g., amplitude accuracy, rate ranges, impedance values) and the measured performance of predicate devices. Performance was verified against these using calibrated test equipment and established metrology practices.

8. The Sample Size for the Training Set:

• Not applicable. The ProSim devices are simulators, not AI/machine learning models that require a training set. They are designed based on established physiological principles and engineering design.

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

• Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for these devices.

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The 6004 NIBP monitor is a portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO2 and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

The BCI 6004 NIBP monitor with optional pulse oximetry (SpO2) and printer is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top non-invasive blood pressure monitor with a desk top charger. The system features an NIBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient data via an LED display (Systolic, Diastolic, & Mean arterial pressure, Interval timer, SpO2, Pulse Rate, Pulse Strength), system status LEDs (Battery, Probe, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of eleven keys (O/I (off/on), START, CANCEL, STAT, Up and Down Arrows, INTRVL, RECALL, MANUAL/AUTO, ALARM SET, & Alarm Silence). The monitor has a serial port that is used for data communication. The model 6004 has two parameters, NIBP and SpO2 plus the integrated printer.

Here's a breakdown of the acceptance criteria and the study details for the BCI 6004 NIBP Monitor, extracted from the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample sizes for the test set and data provenance:

• SpO2 "deep desaturation test": The number of subjects is not explicitly stated. The study for this was conducted at the VA Medical Center in Milwaukee. This appears to be a prospective clinical study given the IRB approval.
• NIBP testing (to ANSI/AAMI SP10-1992): The number of subjects is not explicitly stated. The study was conducted at the VA Medical Center in Milwaukee and at BCI International. This appears to be a prospective clinical study given the IRB approval.
• Simulator Tests (SpO2 & NIBP): These tests involve devices and simulators, not human subjects. The number of readings taken at each setting for NIBP was three.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• SpO2 "deep desaturation test": The ground truth was established by an OSM-3 co-oximeter. No human experts are mentioned as directly establishing the ground truth for SpO2 values in this context.
• NIBP testing (to ANSI/AAMI SP10-1992): The ground truth was established by "manual readings" which implies a human operator taking blood pressure measurements. The number and qualifications of these individuals (e.g., healthcare professionals) are not specified.

4. Adjudication method for the test set:

• SpO2: No explicit adjudication method is mentioned for the SpO2 deep desaturation test. The LOX values were compared directly to the OSM-3 co-oximeter.
• NIBP: For the ANSI/AAMI SP10-1992 standard, the MicroNIBP measurements were compared to the average of the manual readings. This implies that multiple manual readings were taken and averaged to form the ground truth, but no further details on adjudication (e.g., if there were discrepancies between manual readers) are provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The studies focused on device-to-device and device-to-standard comparisons.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, the studies described are standalone performance evaluations of the BCI 6004 monitor itself against simulators, predicate devices, and established standards. While human interaction is involved in operating the device and taking manual readings for NIBP, the performance metrics reported are for the device's output.

7. The type of ground truth used:

• SpO2: The ground truth for SpO2 in the deep desaturation test was based on an OSM-3 co-oximeter, which is a laboratory instrument, not expert consensus or pathology. For simulator tests, the ground truth was the Biotek Index SpO2 simulator.
• NIBP: The ground truth for NIBP was the average of manual readings performed by unspecifed individuals, and for simulator tests, the Dynatech Nevada CuffLink NIBP Analyzer.

8. The sample size for the training set:

• This information is not provided. The document describes performance testing of a finished device, not the development or training of an AI model.

9. How the ground truth for the training set was established:

• This information is not applicable as details about a training set or AI model development are not discussed. The document focuses on demonstrating the performance of the BCI 6004 NIBP Monitor, which is a traditional medical device, against established standards and predicate devices.

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