(116 days)
The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and/or continuous monitoring of patients 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 careqiver can review the historical data whenever needed.
The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera and a portable, table-top wireless Display Unit (DU).
It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements are taken by the SM and are transmitted to the RT which delivers the measurements along with audio/video signals to the DU for display, wherein Bluetooth technology is used to transmit data between the SM and the RT, and data is transmitted from the RT to the DU via the Wi-Fi 802.11 band.
The provided text describes the acceptance criteria and a study for the Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, which measures functional oxygen saturation (SpO2) and pulse rate.
Here's an organized breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device's accuracy was verified through a clinical study. The acceptance criterion for SpO2 accuracy is explicitly mentioned in relation to the FDA guidance.
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Ams (Accuracy root-mean-square) less than 3 digits (70%-100% SpO2 range) as per FDA guidance on Pulse Oximeters - Premarket notification submissions [510(k)] | Ams is less than 3 digits, compliant with FDA guidance on Pulse Oximeters. |
| Pulse Rate | Not explicitly stated as an acceptance criterion in the provided text, but measured. | Pulse rate measurements were taken. (Specific accuracy value not provided within the criteria section in this document excerpt). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: "healthy adult subjects" (number not specified, but stated "Over 200 data points were collected").
- Data Provenance: The study involved "healthy adult subjects" and used "controlled induced hypoxia." The country of origin for the data is not specified within the provided text. It is a prospective study as it involved collecting new data on subjects under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention the use of experts or their qualifications for establishing ground truth in this context. For pulse oximetry accuracy studies, the "ground truth" (reference measurement of arterial oxygen saturation, SaO2) is typically established through co-oximetry of arterial blood samples, not expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth for pulse oximetry accuracy is derived from direct physiological measurements (co-oximetry), not subjective expert judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not conducted. This device is a vital sign monitor, and its performance is evaluated based on the accuracy of its physiological measurements against a reference standard, not human interpretation of images or other data. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this type of device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Yes, the clinical study directly assesses the standalone performance of the device (the oximeter) in measuring SpO2 and pulse rate against a reference standard, without human interpretation of the device's output to determine diagnosis. The Ams value reported represents the algorithm's performance.
7. Type of Ground Truth Used:
The ground truth used was established via physiological measurements during controlled induced hypoxia. While not explicitly detailed in this excerpt, for pulse oximeters, the gold standard for SpO2 "ground truth" is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples.
8. Sample Size for the Training Set:
The provided text does not specify a training set size. This type of device (an oximeter) typically relies on established physiological principles and signal processing algorithms derived from extensive research and development in pulse oximetry, rather than a "training set" in the machine learning sense for a new AI algorithm. While there's internal algorithm development, the document refers to a clinical study for verification of accuracy, not for training a model.
9. How the Ground Truth for the Training Set Was Established:
As no explicit training set is mentioned in the context of a machine learning model, this question is not fully applicable based on the provided text. The device's underlying technology and ground truth for its development would be based on the established physiological relationship between light absorption and oxygen saturation, validated through extensive physiological studies over decades of pulse oximetry development.
§ 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).