(90 days)
The Bird Monitor Interface (BMI) is a stand-alone unit providing a means of communicating information from Bird ventilators to patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin and SpaceLab's PDMS are provided. as well as a Bird proprietary interface for use with other systems. The purpose of BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.
The Bird Monitoring Interface (BMI) is a stand-alone unit providing a communications interface between the Bird ventilators, 8400STi, VIP and TBird, and patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin (via Hewlett-Packard's Vuelink proprietary interface) and SpaceLab's PDMS (via Spacelab's Universal Flexport proprietarv interface) are provided as well as a Bird proprietary interface, the General Purpose Computer Protocol (GPCP), for use with other systems. The purpose of the BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system. The BMI has no user-operated controls or displays. This device is activated when it is attached to a 9 to 15 Volt power supply and fully functional when attached to the ventilator and patient monitoring system. Indicators are limited to a power indicator. The BMI is installed between the ventilator and the Patient Monitoring System. Connection between the ventilator and the BMI is Fiber Optic. Connection between the BMI and the Patient Monitoring System is RS-232 compatible. The BMI also contains a fiber optic feed-through for connection to Bird accessories, particularly the Bird Graphics Monitor and The Partner Volume Monitor. Serial data is received from the ventilator over the fiber optic interface. The fiber optic signal is converted to an electrical signal by a fiber optic receiver. The electrical signal then routes to a fiber optic driver for connection to an accessory device as described above. The electrical signal also routes to the serial input of the microprocessor where the serial data is converted to parallel data. The parallel data is then stored in random access memory (RAM) for future use. Program code for the microprocessor is contained in an electrically programmable read only memory (EPROM) and is accessed as necessary for program execution. Requests from the monitoring system are received as serial RS-232 signals. These signals are converted to logic levels by RS-232 receivers. These logic levels then are processed bv a universal asynchronous receiver transmitter (UART). The UART converts the serial data to parallel data and then notifies the microprocessor by using the interrupt signal. The microprocessor reads the data from the UART, forming a request packet from the monitor. Following receipt of a complete request packet from the monitor, the processor generates the appropriate response packet from the ventilator data stored in RAM. This data is written to the UART, which converts the data to serial form. The serial data is then converted to RS-232 signals and transmitted to the monitor.
The Bird Monitor Interface (BMI) is a communication device, not a diagnostic or AI-powered system that would typically undergo studies involving expert adjudication, MRMC, or training sets in the way more complex medical imaging or AI-driven diagnostic devices would. Its "performance" is based on its ability to accurately transmit data as designed.
Here's the information based on the provided text, recognizing the nature of this device:
Acceptance Criteria and Device Performance
The acceptance criteria for the Bird Monitor Interface (BMI) are derived from its design specifications and its ability to communicate specific data points between Bird ventilators and patient monitoring systems, as well as its compliance with various electrical, environmental, and safety standards. The study performed was focused on verifying that all these specified functions operated as designed.
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Requirement | Reported Device Performance |
|---|---|---|
| BMI interface to T-Bird, 8400STi, and VIP ventilators | Recieve specific Settings, Monitored Values, and Alarm Status from each ventilator model | All listed Settings, Monitored Values, and Alarm Status were verified to be received from each ventilator model. (Indicated by ☑) |
| BMI interface to Hewlett-Packard VueLink and SpaceLabs Universal Flexport | Transmit specific data (Total Breath Rate, Peak Inspiratory Pressure, Mean Airway Pressure, Exhaled Tidal Volume, Exhaled Minute Volume, Inspiratory Time, PEEP/CPAP, Inspiratory Tidal Volume) to respective monitors | All listed data were verified to be transmitted to both Hewlett-Packard and SpaceLabs monitors. (Indicated by ☑) |
| Proprietary Interface | Make all listed T-Bird, 8400, and VIP ventilator data (Settings, Monitored Values, Alarm Status) available through the proprietary interface | All listed T-Bird, 8400, and VIP data were verified to be available through the proprietary interface. (Indicated by ☑) |
| Power On Self Test | Runs at power application, verifies processor operation, EPROM operation, and RAM operation | All power-on self-test functions were verified. (Indicated by ☑) |
| Electrical Requirements | Compliance with IEC601-1:1988 (Electrical Safety, Dielectric Withstand, Leakage Current) | Compliance with IEC601-1:1988 verified. |
| AC Power Grounding and Polarity | Output cable, connector cannot be reversed; reverse polarity will not damage BMI | Verified that reverse polarity does not damage the device. |
| Electromagnetic Compatibility (EMC) | Emissions: IEC 601-1-2, CISPR11 (Radiated and Conducted EMI), MIL-5TD462D, RE101 (Magnetic Fields) | Verified compliance with specified EMC emissions standards. |
| Electromagnetic Compatibility (EMC) | Immunity: IEC 601-1-2, IEC801-2, FDA (Electrostatic Discharge), FDA Reviewer's Guidance (Radiated Electromagnetic Fields, Fluctuations, Transients, Surges, Dropout, Slow Sags and Surges, Fast Surges), IEC801-4 (Fast Transient Bursts), MIL-5TD461D (Conducted EMC), MIL-5TD462D, RS101 (Magnetic Fields), FDA Reviewer's Guidance (Quasi-Static Electric Fields) | Verified compliance with specified EMC immunity standards. |
| Mechanical and Environmental Requirements | Shock (IEC 68-2-27), Sinusoidal Vibration (IEC 68-2-6), Random Vibration (IEC 68-2-34), Fluid Spill Resistance (IEC 601-1, Clause 44.6) | Verified compliance with specified mechanical and environmental standards. |
| Operating Temperature | +10 to +40°C, 30 to 75% RH | Device operated within specified temperature and humidity range. |
| Storage Temperature | -20 to +60°C, up to 95% RH | Device met storage temperature and humidity requirements. |
| Surface Temperature | Less than 41 °C while in an ambient of 35°C | Device maintained surface temperature less than 41°C. |
Study Details:
The provided document describes a performance testing study conducted to verify the functionality and compliance of the Bird Monitor Interface.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical "sample size" in terms of number of devices tested or data points collected for the functional verification. Instead, it states that "All functions were verified to operate as designed and intended." This implies comprehensive testing against each listed function rather than statistical sampling of performance.
- Data Provenance: The testing was conducted "in the laboratory." Environmental, EMI/RFI, and Electrical Safety Standards testing were performed by "certified test facilities." This indicates a controlled, simulated environment, not clinical data from patients or specific geographical origins. The testing is retrospective in nature, verifying the device's adherence to its design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts/Qualifications: Not applicable for this type of device. The ground truth is the device's design specifications and accepted engineering and safety standards (e.g., IEC, CISPR, MIL-STD, FDA Reviewer's Guidance). The "experts" would be the engineers and technicians involved in the design and testing process, and the personnel at the certified test facilities who conduct the standard compliance tests. No clinical "expert" consensus was required as the device's function is data transmission, not clinical interpretation.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Adjudication Method: Not applicable. Functional verification against engineering specifications and industry standards does not involve adjudication by multiple human observers as would be the case for diagnostic accuracy studies. The "adjudication" is essentially a pass/fail determination based on whether the device performs according to its predefined requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. The Bird Monitor Interface is not an AI-powered diagnostic device or an assistive technology for human readers/clinicians, therefore, an MRMC comparative effectiveness study was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, in essence. The "performance testing" described is for the device operating independently to transmit data as specified. While it interfaces with other systems (ventilators and patient monitors), its functionality is standalone in terms of correctly handling and transmitting the data according to its programmed logic. The testing verified the algorithm's (microprocessor's) ability to process and transmit data as per design.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for this device's performance is its design specifications and compliance with recognized national and international engineering, electrical safety, environmental, and electromagnetic compatibility standards (e.g., IEC601-1, CISPR11, MIL-5TD462D, IEC801-2, IEC801-4, IEC 68 series). The "truth" is whether the data transmitted matches the data received from the ventilator, and whether the device operates reliably and safely according to these standards.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. The Bird Monitor Interface is a hardware device with embedded software (firmware) that performs predefined functions. It does not utilize machine learning or AI that requires a "training set" to learn patterns or make predictions. The software is programmed deterministically.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this device. The "ground truth" for the device's functionality is established during its design and engineering phases, based on functional requirements derived from the intended use and compliance standards.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).