(590 days)
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2001) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.
The Guardian Angel Rx GA2000 Series Digital Vital Sigm Monitoring System (Model GA2002) is indicated for use in measuring, recording, and displaying body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2100) is indicated for use in measuring, recording, and displaying function of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.
The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2101) is indicated for use in measuring, recording, and displaying function of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.
The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.
The subject device is a digital vital sign monitoring system that measures and displays a patient's vital signs, i.e. pulse rate, oxygen saturation (SpO2) and body temperature. 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 vital signs fall outside of pre-set limits or when a technical error is detected. During a physiological alarm event, the vital sign data along with the audio/video data are recorded automatically by the subject device. The caregiver can review the historical data whenever needed.
The sensor module(s) of the subject device detects vital signs and sends out the data to the Receiver/Transponder using Bluetooth technology. The Receiver/Transponder then transmits, via a customer Wi-Fi network, the physiological data along with audio/video signals obtained by an embedded camera to an Aulisa-supplied tablet (i.e. the Display Unit).
The subject device contains a total of three Aulisa sensor modules, Adult/Pediatric Oximeter Module, Infant Oximeter Module, and Thermometer Module. The three Aulisa sensor modules connect to the Receiver/Transponder either independently or simultaneously, resulting in five system configurations and system model names as listed below.
The provided document describes the Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents acceptance criteria primarily for the functional oxygen saturation (SpO2), pulse rate (PR), and body temperature measurements.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulse Oximetry (SpO2) | Accuracy (No Motion): ± 3 digits (70-100%) | SpO2 accuracy calculated using root-mean-square (A-rms) was less than 3 digits during steady-state conditions over the range of 70-100%. |
| Pulse Rate (PR) - GA2000/GA2100 | Accuracy (No Motion): ± 3% (30-290 bpm) | The document states SpO2 accuracy was compliant with specified performance; PR accuracy is implicitly covered by consistency with predicate. (Explicit PR accuracy result for the subject device is not separately stated beyond the criteria). |
| Pulse Rate (PR) - GA2001/GA2101 | Accuracy (No Motion): ± 3 digits (18-300 bpm) | The document states SpO2 accuracy was compliant with specified performance; PR accuracy is implicitly covered by consistency with predicate. (Explicit PR accuracy result for the subject device is not separately stated beyond the criteria). |
| Body Temperature (GA2002/GA2100/GA2101) | Accuracy: 89.6°F-107.6°F: ± 0.2°F (32°C-42°C: ± 0.1°C) | The output temperature is derived directly from the input signal without adjustment, implying it meets this specification. |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | Pass |
| Temperature and Humidity | IEC 60601-1 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Defibrillation Protection | IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61, ASTM E1112, IEC 60601-1-8, IEC 60086 series | Pass |
| Mechanical Durability | IEC 60601-1, IEC 60601-1-11 | Pass |
| Biocompatibility | ISO 10993-5, ISO 10993-10 | Pass |
| Software V&V | FDA Guidance | Pass |
| Bench testing for Accuracy | Manufacturer's specifications | Pass |
| Security Testing | - | Pass |
| Wireless Coexistence Testing | ANSI C63.27 | Pass |
| Durability and Performance testing | Manufacturer's specifications | Pass |
| CR2025 Battery Life Testing | Manufacturer's specifications | Pass |
2. Sample Size and Data Provenance for Test Set
The "clinical evaluation for SpO2 accuracy" was conducted on a test set of "healthy male and female, light to dark skinned subjects."
The document does not specify the exact sample size used for this SpO2 clinical test set.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts and Qualifications for Ground Truth
For the SpO2 clinical evaluation, there is no mention of experts establishing ground truth. Instead, the "functional oxygen saturation (SpO2) measurements of the subject device were validated in accordance with ISO 80601-2-61." This standard typically involves comparison against an invasive co-oximeter reference measurement, which is considered the ground truth. There are no experts involved in establishing this physiological ground truth for SpO2.
For body temperature, "the output temperature of the subject device is derived directly from input signal without any adjustment," implying that the ground truth for temperature measurement would be based on a calibrated reference thermometer, also not requiring experts for ground truth establishment.
4. Adjudication Method
The document does not mention an adjudication method for the test set. Given the nature of physiological measurements (SpO2 and temperature), adjudication by multiple experts is typically not part of the validation process, as the ground truth is established through direct physiological measurement by a gold-standard device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the document. This type of study is more common for diagnostic imaging AI devices where human interpretation needs to be evaluated with and without AI assistance. The Guardian Angel Rx GA2000 Series is a vital sign monitoring system, not an imaging interpretation aid.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm (device-only performance).
The clinical evaluation for SpO2 accuracy was conducted to determine the device's accuracy in measuring SpO2 (A-rms less than 3 digits from 70-100%).
Similarly, the body temperature measurement accuracy and various other technical tests (electrical safety, EMC, mechanical durability, etc.) represent standalone performance evaluations of the device.
7. Type of Ground Truth Used
- For SpO2: The ground truth for SpO2 accuracy was established through comparison with a reference standard as specified by ISO 80601-2-61. This standard typically mandates the use of an invasive co-oximeter for arterial blood gas analysis as the reference ground truth.
- For Body Temperature: The ground truth for body temperature measurement would be a highly accurate and calibrated reference thermometer, as the device's output is derived directly from input signal without any adjustment.
8. Sample Size for the Training Set
The document does not specify any sample size for a training set. This device functions as a sensor and measurement system, rather than an AI/ML model that would require a separate "training set" in the conventional sense. Its performance is validated against physiological standards and predicate devices.
9. How Ground Truth for Training Set was Established
As no training set is mentioned or implied for an AI/ML model, the establishment of its ground truth is not applicable in this context. The validation for this vital sign monitor relies on direct comparison to established physiological measurement standards in a test setting.
§ 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).