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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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