(87 days)
The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP 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 electronic thermometry option requires Welch Allyn thermometry probes and probe covers and provides oral or rectal temperature information for patients neonate through 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 for the NIBP and oximetry functions.
The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, and printer has been updated to include an additional electronic thermometer option which uses the same technology as existing legally marketed devices. This device is designed to provide full-featured monitoring capabilities in a lightweight, transportable design. The system consists of a small tabletop NIBP monitor with a desktop charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
The provided text describes the BCI Mini-Torr Plus (model 6004) with a new electronic thermometer option. The study aims to demonstrate that the performance of this updated device is substantially equivalent to existing legally marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (within specified tolerances of monitors and simulators, and ±0.2°F for temperature) | Reported Device Performance (Average difference between predicate and new device) |
|---|---|---|
| Systolic Pressure (NIBP) | Within specified tolerances | -0.14 mmHg |
| Diastolic Pressure (NIBP) | Within specified tolerances | 0.07 mmHg |
| Mean Arterial Pressure (MAP) (NIBP) | Within specified tolerances | 0.07 mmHg |
| Heart Rate (NIBP) | Within specified tolerances | 0 bpm |
| SpO2 (Oximetry) | Within specified tolerances | 0% |
| Heart Rate (Oximetry) | Within specified tolerances | 0 bpm |
| Temperature | Within specified tolerance (±0.2 °F) | -0.04 °F |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size (e.g., number of patients or trials) for the comparison testing. Instead, it mentions:
- NIBP and Oximetry: Measurements were made using "simulators" with settings spanning the 6004's entire specification range. This suggests comprehensive testing across various operational conditions.
- Temperature: Both devices simultaneously measured temperature in a "water bath over their entire specified temperature range (84 - 108 °F)."
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in relation to the device's development, as it describes validation testing performed before seeking regulatory approval.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This study does not involve human experts to establish ground truth in the traditional sense of diagnostic interpretation. Instead, the ground truth is established by:
- Predicate Devices: The performance of the predicate BCI 6004 NIBP monitor and the Welch Allyn 678 SureTemp Thermometer serves as the reference or "ground truth" against which the new device's performance is compared for substantial equivalence.
- Simulators: For NIBP and oximetry, simulators were used, implying their known and controlled outputs served as the reference.
- Water Bath: For temperature, a water bath with a known temperature range provided the reference.
No human experts were used for adjudication of the test results themselves.
4. Adjudication Method for the Test Set
No human adjudication method (like 2+1, 3+1) was used for this study. The comparison was quantitative, directly comparing measurements from the new device against predicate devices and simulators/controlled environments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This study focuses on direct device performance comparison, not on evaluating human reader improvement with or without AI assistance. The device in question is a physiological monitor, not an AI-powered diagnostic tool.
6. Standalone Performance
Yes, a standalone performance assessment was effectively done. The "new 6004 with temperature option" device was tested independently and its measurements were then compared against established predicate devices and simulators. This assesses the algorithm/device's performance without human intervention in the measurement process.
7. Type of Ground Truth Used
The ground truth for this study was established using:
- Predicate Devices: The established performance and readings of the BCI 6004 NIBP monitor and the Welch Allyn 678 SureTemp Thermometer.
- Simulators: Controlled devices with known outputs for NIBP and Oximetry parameters.
- Controlled Environment: A water bath with a defined temperature range for thermometry testing.
Essentially, the ground truth was based on known and validated performance of existing, legally marketed devices and controlled testing environments.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a medical device validation study focused on demonstrating substantial equivalence, not a machine learning model development study. Therefore, the concept of a training set as typically understood in AI/ML is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML model, this question is not applicable. The device's design utilizes "currently available technology found in many legally marketed devices," implying established engineering principles and components rather than a data-driven learning approach.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).