Search Results
Found 2 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(245 days)
Aulisa Temperature Module (TM0002) is a battery-operated electronic device with indication for use in continuously measuring and monitoring armpit body temperature of adults, pediatrics, and infants and transmission of the measuring result via wireless signal. Aulisa Temperature Module (TM0002) is a non-invasive and reusable device for single patient use with intended environments of use are hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Temperature Module (TM0002) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
The Aulisa Temperature Module (TM0002) is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants which measures body temperature and sends the physiological data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under 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 to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, thirdparty 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 display and review. The software application can be downloaded from an official APP store, such as iOS APP store or Google Play. The Subject Device is reusable, and its intended environments of use are hospitals, medical facilities, home care, and subacute environments.
Here's an analysis of the provided information regarding the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1, IEC 60601-1-11) | Pass |
| Temperature and Humidity (IEC 60601-1, IEC 60601-1-11) | Pass |
| Atmospheric Pressure (Altitude) (IEC 60601-1) | Pass |
| Electromagnetic Immunity and Emissions (IEC 60601-1-2) | Pass |
| Performance (Temperature Measurement Accuracy) (ISO 80601-2-56, ASTM E1112) | Pass |
| Under 37°C: ± 0.2°C | |
| 37.1~39.0°C: ± 0.1°C | |
| 39°C and above: ± 0.2°C | |
| Mechanical Durability (IEC 60601-1, IEC 60601-1-11) | Pass |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Pass |
| Wireless Coexistence Testing (ANSI C63.27) | Pass |
| Software V&V (Guidance for the Content of Premarket Submissions for Device Software Functions) | Pass |
| Security Testing (Cybersecurity in Medical Devices, Quality System Considerations and Content of Premarket Submissions) | Pass |
| Usability Testing (Applying Human Factors and Usability Engineering to Medical Devices) | Pass |
| Clinical Electronic Thermometer (Enforcement Policy for Clinical Electronic Thermometers, Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers) | Pass |
| Bench Testing (Durability and Performance testing, Battery Life Testing) | Pass |
Note on Performance (Temperature Measurement Accuracy): The document explicitly states the specific accuracy values for different temperature ranges, which are considered "Pass" when measured against the standards ISO 80601-2-56 and ASTM E1112. These are the acceptance criteria for the accuracy.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set for any of the reported performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the accuracy or other performance tests. It only states that "Clinical accuracy testing was conducted to ISO 80601-2-56."
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 regarding the number of experts used or their qualifications for establishing ground truth. For temperature measurement, the ground truth is typically established by reference thermometers or established methods defined within the testing standards (ISO 80601-2-56 and ASTM E1112), rather than expert consensus in the way it would be for image interpretation.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method like 2+1 or 3+1. For objective performance tests like temperature accuracy, adjudication methods for expert consensus are generally not applicable. The standards themselves define the criteria for "passing" the test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable to the Aulisa Temperature Module (TM0002). This device is a clinical electronic thermometer and not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study or analysis of human reader improvement with AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device is a hardware module that measures temperature and transmits it. Its "performance" as a standalone device is covered by the performance testing (e.g., accuracy, electrical safety, etc.) which are conducted independent of a human interpreting its output. The output is displayed via an application, but the core measurement accuracy is inherent to the device itself. The document states that "The output temperature of the Subject Device is derived directly from input signal without any adjustment," implying its core function is standalone.
7. The Type of Ground Truth Used
For the core performance claims (e.g., temperature accuracy), the ground truth is established through reference standards as defined by ISO 80601-2-56 and ASTM E1112. These standards specify how to establish laboratory-controlled "true" temperatures to compare against the device's readings. This is a form of scientific/methodological ground truth rather than expert consensus or pathology.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the Aulisa Temperature Module (TM0002) is a direct measurement device rather than a machine learning or AI-based device that would require a "training set." Its accuracy is based on its sensor technology and calibration, not learned from data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.
Ask a specific question about this device
Page 1 of 1