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510(k) Data Aggregation
(169 days)
Guardian Angel GA1000 Digital Vital Sign Monitoring System
The Guardian Angel GA1000 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 environment of use is hospital. This system is a reusable device.
Aulisa's GA1000 is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation level. The system includes a self-contained wrist-worn Sensor Module and a portable, table-top wireless Display Unit. The Guardian Angel GA1000 Digital Vital Sign Monitoring System is also equipped with an alarm system that alerts the caregiver when a patient's pulse rate is too low or too high and when the patient's SpO2 is too low or too high.
Guardian Angel GA1000 Digital Vital Sign Monitoring System contains the following components.
- Sensor Module ●
- Display Unit ●
- Finger Sensor ●
- Sensor Module wristband ●
- Sensor Module Charging Adaptor ●
- Display Unit Charging Adaptor ●
- . Display Unit Stand
The GA1000 measures SpO2 and pulse rate based on transmittance technology, measuring the absorbance of red and infrared light passed through the tissue.
The GA1000 uses Bluetooth v4.0 to transmit data between the wrist-worn Sensor Module and the wireless Display Unit. Both the Sensor Module and the Display Unit is Bluetooth® 4.0 compatible.
The GA1000 uses non-invasive red and infrared LED sensors to measure the functional blood oxygen saturation and pulse rate. The measurements are wirelessly transmitted to the Display Unit, which displays the measurements using a Liquid-Crystal-Display (LCD) panel. The system provides adjustable visual and audio oxygen saturation, and pulse rate alarms through the LCD panel and speakers. Additional alarms are featured, including low battery on the Sensor Module, Sensor Cable disconnection, Sensor Module disconnection, Sensor Cable Probe fault, Sensor Probe detached from patient, Display Unit battery low.
Here's an analysis of the acceptance criteria and study information for the Guardian Angel GA1000 Digital Vital Sign Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Guidance) | Reported Device Performance (Guardian Angel GA1000) |
|---|---|
| SpO2 Accuracy (Declared Range: 70-100%, No Motion) | Adults/Pediatrics: 3 digits (Specific sensor types: SC100M, ENSC100M; Adults: SC100L, ENSC100L) |
| Pulse Rate Accuracy (No Motion) | Adults/Pediatrics: ±3% (Specific sensor types: SC100M, SC100L, ENSC100M, ENSC100L) |
| SpO2 Accuracy in induced hypoxia (70-100% SpO2) | Arms of each sensor is below 3% (compliant with FDA guidance on Pulse Oximeter - Premarket notification submissions [510(k)]: Guidance for Industry and Food and Drug Administration staff, Issued March 4th, 2013) |
| Electrical Safety (IEC 60601-1:2005) | Compliant with IEC 60601-1 |
| Biocompatibility (ISO 10993-10: 2010, ISO 10993-5:2009) | Biocompatible for patient contact materials; compliant with ISO 10993-5 and ISO 10993-10 |
| Electrical Safety & EMC (IEC 60601-1-2:2007) | Compliant with IEC 60601-1-2 |
| Alarm System (IEC 60601-1-8:2006) | Compliant with IEC 60601-1-8 |
| Wireless Coexistence (FDA Guidance Radio Frequency Wireless Technology in Medical Devices (2013)) | Tested for Radio Frequency Compatibility and Emissions/Immunity Tests |
| Software Verification (IEC 62304:2006, FDA Guidance Off-The-Shelf Software Use in Medical Devices (1999)) | Compliant with IEC 62304 and FDA Guidance Off-The-Shelf Software Use in Medical Devices (1999) |
| Pulse Oximetry Testing (ISO 80601-2-61:2011, FDA Pulse Oximeters Guidance (2013)) | Compliant with ISO 80601-2-61 and FDA Pulse Oximeters Guidance (2013) |
| Functional Test | Performed |
| Push, Impact, and Drop Test | Performed |
| Particulate and Water Ingress Test | Performed |
| Temperature and Humidity Test | Performed |
| Battery Life Test | Performed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for SpO2 Accuracy (Clinical Testing): "Over 200 data points were collected for each sensor." This implies the sample size refers to the number of data points, not necessarily individual subjects.
- Data Provenance: The study was conducted on "healthy adult subjects." The document does not specify the country of origin of the data, but the submitting company is based in Taiwan. The study was prospective in nature, involving induced hypoxia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the clinical test set. For pulse oximetry, the ground truth for SpO2 is typically established using a co-oximeter on arterial blood samples, which is a laboratory measurement rather than an expert consensus process.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the clinical test set. For pulse oximetry accuracy during induced hypoxia, the comparison is typically made between the device reading and the gold standard co-oximetry reading, rather than relying on expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. The Guardian Angel GA1000 is a vital sign monitoring device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The clinical testing described for SpO2 accuracy (induced hypoxia study) and the various non-clinical tests (electrical safety, EMC, software, etc.) evaluate the device's performance in isolation, without human intervention in the core measurement and algorithm functionality.
7. Type of Ground Truth Used
For the clinical testing of SpO2 accuracy, the ground truth was established through controlled induced hypoxia conditions, implying comparison against a reference method such as co-oximetry from arterial blood samples (though co-oximetry is not explicitly named, it's the standard for this type of testing).
8. Sample Size for the Training Set
The document does not specify the sample size for any training set. As this device appears to be primarily an embedded system for measuring vital signs, it may not rely on a "training set" in the same way a machine learning-based AI diagnostic tool would. If there is any internal algorithm tuning or calibration, the details are not provided.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, the method for establishing its ground truth is also not specified.
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