(148 days)
The Guardian Angel Rx GA1001 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). The subject device consists of a selfcontained foot-worn sensor module (SM) 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 taken by the SM are wirelessly transmitted to the DU for display using Bluetooth technology. The subject device also 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System
Purpose: Measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Primarily for pediatrics and infants during non-motion and well-perfused conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Pulse Oximetry Accuracy (SpO2): Accuracy (Arms) below 3% over the range of 70%-100% SpO2 | Arms is below 3%, compliant with FDA guidance on Pulse Oximeters - Premarket notification submissions [510(k)]. |
| Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-8 | Device complies with these standards. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | Device complies with this standard. |
| Biocompatibility: Meet requirements of ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Biocompatibility evaluation conducted, including Cytotoxicity, Sensitization, and Irritation tests. (Implicitly passed as it supports substantial equivalence). |
| Software Verification & Validation: Documentation provided as recommended by FDA guidance. | Software verification and validation testing conducted and documentation provided. (Implicitly passed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Study): "Over 200 data points were collected."
- Data Provenance:
- Country of Origin: Not explicitly stated, but the applicant is "Taiwan Aulisa Medical Devices Technologies, Inc." This suggests the clinical study could have been conducted in Taiwan or another location consistent with the applicant's operations.
- Retrospective or Prospective: "Clinical data were collected... to verify the accuracy of the subject device on healthy subjects over the range of 70%-100% SpO2 through controlled induced hypoxia." This indicates a prospective clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an oximeter, not an AI/imaging device requiring expert interpretation for ground truth. The ground truth for SpO2 accuracy is established through controlled induced hypoxia measurements against a reference standard (likely arterial blood gas measurements, though not explicitly stated, this is the standard for pulse oximetry accuracy). Therefore, the concept of "experts establishing ground truth" in the context of interpretation (like radiologists for imaging) does not apply here. The expertise required would be in conducting the induced hypoxia study and accurate blood gas analysis.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for pulse oximetry accuracy is derived from physiological measurements (e.g., arterial blood gas analysis under controlled hypoxia), not subjective expert judgment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret cases with and without AI assistance (e.g., radiologists reading medical images). The Guardian Angel Rx GA1001 is a vital sign monitoring system, not an AI-powered diagnostic imaging tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The clinical study described (measuring SpO2 accuracy through controlled induced hypoxia) is a standalone performance evaluation of the device. It assesses the device's ability to accurately measure SpO2 directly, without human interpretation as part of the primary measurement function. The performance metric "Arms is below 3%" directly reflects the algorithm's (and hardware's) accuracy compared to the reference standard.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was established through controlled induced hypoxia on healthy subjects. In the context of pulse oximetry, this typically involves comparing the device's SpO2 readings to simultaneously measured arterial oxygen saturation (SaO2) values obtained from arterial blood gas (ABG) analysis. The sO2 (and corresponding SaO2) values from the ABG are considered the "ground truth."
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. For hardware devices with embedded algorithms like pulse oximeters, the "training" (calibration and refinement of algorithms) typically happens during development and might use internal data or general physiological models. The provided study describes the validation/test set used for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As no information is provided about a distinct "training set" in the context of machine learning, the method for establishing its ground truth is not detailed. For traditional medical device algorithms, the "ground truth" for development and calibration would be established through established scientific principles, extensive physiological data, and potentially iterative testing against reference methods (like ABG) during the R&D phase.
§ 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).