(412 days)
The Aulisa Infant Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of infant patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1001 Series Digital Vital Sign Monitoring System (K182822) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device flashes LED light as a visual alarm signal, to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play. The subject device contains an Oximeter Box and an Oximeter Sensor resulting in device configuration and model names as listed below.
The provided text describes the acceptance criteria and performance study for the Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy (No motion, 70-100%) | ± 3 digits |
| Pulse Rate Accuracy (No motion) | ± 3 digits (30-290 bpm) |
| Electrical Safety | Pass (IEC 60601-1, IEC 60601-1-11) |
| Temperature and Humidity | Pass (IEC 60601-1, IEC 60601-1-11) |
| Atmospheric Pressure (Altitude) | Pass (IEC 60601-1) |
| Electromagnetic Immunity and Emissions | Pass (IEC 60601-1-2) |
| Performance (Pulse Oximeter Standard) | Pass (ISO 80601-2-61) |
| Mechanical Durability | Pass (IEC 60601-1, IEC 60601-1-11) |
| Biocompatibility | Pass (Skin contact: ISO 10993-5, ISO 10993-10, ISO 10993-23) |
| Software V&V | Pass (FDA Guidance) |
| Security Testing | Pass (FDA Guidance) |
| Wireless Coexistence Testing | Pass (ANSI C63.27) |
| Clinical Testing (Pulse Oximeters) | Pass (FDA Guidance) |
| Usability Testing | Pass (FDA Guidance) |
| Bench Testing | Pass (Manufacturer's specifications) |
| Durability and Performance Testing | Pass (Manufacturer's specifications) |
| Battery Life Testing | Pass (Manufacturer's specifications) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the exact number of subjects used in the clinical evaluation. It mentions "healthy male and female, light to dark skinned subjects."
- Data Provenance: The study was a clinical evaluation conducted on human subjects. The details on the specific country of origin are not provided, but it pertains to the validation of a device manufactured by "Taiwan Aulisa Medical Devices Technologies, Inc." The study is prospective in nature, as it is a "clinical evaluation for SpO2 accuracy was conducted on healthy male and female..."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about experts establishing ground truth for the test set or their qualifications. The clinical evaluation describes measuring SpO2 and pulse rate on subjects, which implies comparison against a reference oximeter or arterial blood gas measurements, but doesn't detail the expert review process for ground truth.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a pulse oximeter for direct physiological measurement, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The primary clinical testing described is a standalone performance evaluation of the device's SpO2 accuracy against a reference method (likely arterial blood gas measurements, standard for pulse oximeter accuracy testing per ISO 80601-2-61), without a human-in-the-loop aspect being assessed. The device itself automatically measures and transmits data.
7. The type of ground truth used
The ground truth for SpO2 accuracy in the clinical evaluation was established by comparing the device's measurements against a reference method, typically arterial blood gas measurements (which are the gold standard for SpO2 calibration and accuracy testing in pulse oximetry, as implied by compliance with ISO 80601-2-61). The reported metric is Accuracy root-mean-square (ARMS).
8. The sample size for the training set
The document does not specify a separate "training set" or its sample size. For pulse oximeters, the development and verification typically involve laboratory calibration and then human clinical studies for validation. If any internal model training occurred, those details are not provided in this 510(k) summary.
9. How the ground truth for the training set was established
As no specific training set is mentioned for data-driven model training, the method for establishing its ground truth is not applicable or provided in this document. The device's performance is validated through clinical evaluation in accordance with established standards for pulse oximeters.
§ 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).