(87 days)
The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry ootion works with all BCI oximetry probes providing SpO2 and pulse rate. The patient population is defined to be pediatric to adults.
The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122° F (0 to 50° C).
The BCI Capnocheck Plus capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2) is an updated version of existing devices legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top capnograph with a wall mount charger. The system features a gas inlet port with moisture trap for the breath sample (sidestream capnograph), an SpO2 probe interface, the FiO2 sensor connector, display of patient data via a VFD display (CO2, SpO2, Pulse Rate, Pulse Strength, FiO2, alarm information), system status LEDs (Battery, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of six keys (STNBY/ON, WAVE/TREND, Up and Down Arrows, MENU/ENTER, & Alarm Silence). The capnograph has a serial printer / pc port that is used for data communication. Three analog output channels are supported on the same connector.
The document describes the BCI Capnocheck® Plus, Model 9004, a capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2) monitoring capabilities.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it broadly states that the device was tested to "perform within its specifications and functional requirements" and "in compliance with the guidelines and standards referenced in the reviewers guide for respiratory devices."
However, specific performance claims and results are mentioned, particularly for the oximetry function. These can be inferred as de facto acceptance criteria.
Inferred Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | Perform within specifications and functional requirements. | "The results of the testing demonstrated that the device was in compliance with the guidelines and standards referenced in the reviewers guide and that it performed within its specifications and functional requirements." |
| In compliance with guidelines and standards (EMC, electrical, mechanical durability, safety, temperature/humidity) from the reviewers guide for respiratory devices. | "Testing was done to ensure that it would perform within the environment(s) for which it is to be marketed. The testing was performed in accordance with the guidelines and standards found in the reviewers guide for respiratory devices. This testing included EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. The results of the testing demonstrated that the device was in compliance with the guidelines and standards referenced in the reviewers guide..." | |
| CO2, RR, SpO2 & HR | Performance comparable to the predicate device (BCI 9000). | "Performance testing between the new 9004 and the predicate 9000 was done to show that the performance of the two devices is the same (CO2, RR, SpO2 & HR). All the results of each parameter of each device were the same or within one count of each other." (This implies a very close match, likely within typical measurement variability). |
| Capnography (CO2) | Accurate response time, accuracy & linearity with humidity, over temperature & at altitude. Resistant to temperature shock, interfering gases. Proper breath rate, contamination, and water trap testing. Appropriate recalibration interval. | "An in-house performance test of the 9004 was run. It tested CO2 response time, accuracy & linearity with humidity & over temperature & at altitude, temperature shock, interfering gases, breath rate, contamination and water trap testing. The testing to determine how often the unit needs to be recalibrated was also completed. The 9004 passed all the tests." (This indicates successful performance across these conditions). |
| FiO2 Function | Accurate over a range of O2 values. | "The FiO2 function was tested with O2 values of 0%, 21%, 60% and 100% oxygen. The 9004 passed all the tests." |
| Pulse Oximetry (SpO2) | Accurately displays patient's blood oxygen level within accuracy limits compared to a co-oximeter. | "Statistically significant accuracy claims," specifically: |
- Standard Deviation (SD) for 70-100% SpO2 range: 2.0
- Standard Deviation (SD) for 50-69% SpO2 range: 2.7
- R-squared value over the entire range: 0.97 (indicating a strong correlation with the co-oximeter) |
Study Details for SpO2 Performance
The most detailed performance study described is for the optional pulse oximetry (SpO2) function.
-
Sample Size used for the test set and the data provenance:
- The document states "clinically controlled desaturation studies of the optional oximeter were done." It does not specify the exact sample size (number of subjects).
- The data provenance is clinical, though the specific country of origin is not explicitly stated. The context implies it was likely conducted in the US, given the submission to the FDA. It was a prospective study ("controlled subject desaturation runs").
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the number of experts or their qualifications for establishing ground truth.
-
Adjudication method for the test set:
- The document does not describe an adjudication method. The ground truth seems to be established by the co-oximeter.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study involving human readers comparing AI vs. no-AI assistance was not done. This device is a medical monitoring instrument, not an AI diagnostic tool that assists human readers with interpretation.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance study for the SpO2 function (and other parameters) describes the device's standalone performance compared to a reference standard (co-oximeter for SpO2).
-
The type of ground truth used:
- For the SpO2 accuracy, the ground truth was comparison to a co-oximeter (OSM-3) during controlled desaturation studies. This is a common and accepted clinical reference standard for blood oxygen saturation.
- For other parameters (CO2, RR, HR, FiO2), the ground truth appears to be based on "in-house performance tests" and comparison to a "predicate 9000" device, implying established laboratory standards and a legally marketed reference device.
-
The sample size for the training set:
- This information is not provided. As this is a medical device for monitoring physiological parameters, not a machine learning model, the concept of a "training set" in the context of AI is not directly applicable. The device's algorithms would have been developed and refined through engineering and calibration processes, not data training in the AI sense.
-
How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device in the modern sense of a "training set." Device calibration and algorithm development would typically rely on established physical principles, engineering standards, and potentially in-house testing against known reference values or predicate devices, rather than a "ground truth" derived from a separate dataset for training.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).