(50 days)
The Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-checking and/or continuous monitoring of pediatrics and infants during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO₂). It is also equipped with an audio/video camera to monitor the patient in real time. In addition, the subject device provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected. During a physiological alarm event, the pulse rate and SpO2 data along with the audio/video data are recorded automatically by the subject device. The caregiver can review the historical data whenever needed.
The system consists of a self-contained foot-worn Sensor Module, a Receiver/Transponder with an embedded audio/video camera and a portable, table-top wireless Display Unit.
It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements are taken by the Sensor Module and are transmitted to the Receiver/Transponder which delivers the measurements along with audio/video signals to the Display Unit for display, wherein Bluetooth technology is used to transmit data between the Sensor Module and the Receiver/Transponder, and data is transmitted from the Receiver/Transponder to the Display Unit via the Wi-Fi 802.11 band.
Here's an analysis of the acceptance criteria and study information for the Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states acceptance criteria for SpO2 and Pulse Rate accuracy.
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (no motion, 70-100%) | ± 3 digits | Arms below 3% |
| Pulse Rate Accuracy (18-300 bpm) | ± 3 digits | Not explicitly stated with a performance metric, but the device is stated to meet the ± 3 digits (18-300 bpm) accuracy as per the comparison table and the clinical study confirms SpO2 accuracy, implying overall accuracy. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): "Over 200 data points were collected." The clinical study focused on collecting data points for SpO2 accuracy.
- Data Provenance: The study was conducted on "healthy subjects" and involved "controlled induced hypoxia." The country of origin for the study is not explicitly stated within the provided text. It is a prospective study as data was "collected" to verify accuracy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts used or their qualifications for establishing the ground truth. This is common in pulse oximetry studies where ground truth for SpO2 is typically established using a co-oximeter connected to an arterial blood gas sample, which is a direct measurement, not an expert visual interpretation.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method for the test set. Given the nature of pulse oximetry accuracy studies, where ground truth is typically derived from direct physiological measurements (co-oximetry) rather than subjective interpretation, an adjudication process involving multiple experts is generally not applicable or necessary for the primary accuracy endpoint.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. The study described is a clinical accuracy study for a device measuring physiological parameters, not an interpretive task that would typically involve multiple readers (like radiologists reviewing images). Therefore, there is no effect size of human readers improving with or without AI assistance reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the clinical study described is a standalone performance study. It directly assessed the accuracy of the device's SpO2 measurements against a reference standard without human interpretation being part of the primary measurement endpoint.
7. The Type of Ground Truth Used:
The ground truth for SpO2 accuracy was established through controlled induced hypoxia in healthy subjects. This typically involves simultaneously measuring arterial oxygen saturation using a laboratory co-oximeter (considered the gold standard) from arterial blood samples while comparing it to the device's readings. While "co-oximetry" isn't explicitly named, "controlled induced hypoxia" is the standard method for generating a wide range of accurately known SpO2 values.
8. The Sample Size for the Training Set:
The document does not provide information regarding a "training set" or its sample size. This device appears to be a hardware-based physiological monitoring system, not an AI/ML-driven solution that would typically involve a distinct training set for an algorithm. The clinical data mentioned is for performance verification.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned for an AI/ML model, the establishment of ground truth for a training set is not applicable here. The "clinical study" described serves as the validation/test set for the device's accuracy.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).