(438 days)
The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric 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 Oximeter Module (2nd Gen.) is a wireless, wrist-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 GA1000 Series Digital Vital Sign Monitoring System (K162580) & 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 backlight of the vital sign will turn to RED colour 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 provided text is a 510(k) Summary for the Aulisa Oximeter Module (2nd Gen.). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the full study design and results of performance evaluations in the granular detail requested.
However, based on the information provided, here's an attempt to extract the relevant details for the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "The SpO2 accuracy data were calculated using the Accuracy root-mean-square (ARMS) and the results which indicated that the subject device had an ARMs less than 3 digits during steady-state conditions over the range of 70-100% were in compliance with the specified performance claimed by the manufacturer." This is the primary performance claim related to SpO2 accuracy.
| Acceptance Criteria (Metric) | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (ARMS) | Less than 3 digits | Less than 3 digits |
| SpO2 Range for Accuracy | 70-100% | 70-100% |
| Pulse Rate Accuracy | ± 3 digits (or ± 3%) | ± 3 digits (30-290 bpm) or ± 3% (30-290 bpm) |
| Pulse Rate Range for Accuracy | 30-290 bpm | 30-290 bpm |
| Electrical Safety | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Temperature and Humidity | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Atmospheric Pressure (Altitude) | Pass IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | Pass IEC 60601-1-2 | Pass |
| Performance (General) | Pass ISO 80601-2-61 | Pass |
| Mechanical Durability | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Pass ISO 10993-5, ISO 10993-10, ISO 10993-23 | Pass |
| Software V&V | Pass FDA Guidance | Pass |
| Security Testing | Pass FDA Guidance | Pass |
| Wireless Coexistence Testing | Pass ANSI C63.27 | Pass |
| Clinical Testing (General) | Pass FDA Guidance | Pass |
| Usability Testing | Pass FDA Guidance | Pass |
| Bench Testing | Pass Manufacturer's specifications | Pass |
| Durability and Performance | Pass Manufacturer's specifications | Pass |
| Battery Life Testing | Pass Manufacturer's specifications | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: The document only states "The clinical evaluation for SpO2 accuracy was conducted on healthy male and female, light to dark skinned subjects." It does not specify the number of subjects (sample size).
- Data Provenance: The document does not explicitly state the country of origin. It describes the test as a "clinical evaluation," implying a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an oximeter, "ground truth" for SpO2 is typically established by arterial blood gas analysis, which does not involve experts in the same way as, for example, image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided as the "ground truth" for SpO2 accuracy in oximetry is typically established by a direct comparison to a reference standard (e.g., co-oximetry of arterial blood samples), not by expert adjudication.
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
This is not applicable. The Aulisa Oximeter Module is a device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic tool that requires human readers for interpretation. Its performance is evaluated against reference standards, not human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the SpO2 accuracy evaluation (against ISO 80601-2-61 and FDA Guidance) would be considered a standalone performance test of the device's ability to measure SpO2. The device directly measures and outputs these values, so its performance is inherently "standalone."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for SpO2 accuracy in oximetry studies is typically established using arterial blood gas analysis (specifically, co-oximetry) as the reference standard, allowing for precise measurement of arterial oxygen saturation. This is implied by the reference to ISO 80601-2-61, which outlines these methodologies.
8. The sample size for the training set
This information is not applicable/provided. This device is a hardware oximeter module that directly measures physiological signals and processes them to derive SpO2 and pulse rate. It does not appear to involve a machine learning model that would require a separate "training set" in the common sense of AI/ML development. Its "training" would be more akin to calibration and algorithm refinement based on engineering principles and physiological models.
9. How the ground truth for the training set was established
As per point 8, this is not applicable.
§ 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).