(558 days)
The AVITA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.
The AViTA Pulse Oximeter SPO2 is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for life-sustaining, not for implant and does not contain drug or biological products. The device is for prescription use only. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.
Here's a breakdown of the acceptance criteria and the study that proves the AViTA Pulse Oximeter meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy (70% to 100% range) | ± 2% |
| Pulse Rate Accuracy | ±2 bpm or ±2%, whichever is greater |
| Clinical Performance (SpO2 under no motion) | ARMS (Accuracy Root Mean Square) for SpO2 = 1.89% |
| Electrical Safety | Complied with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2 |
| Biocompatibility - Cytotoxicity | Complied with ISO 10993-5 (in accordance with ISO 10993-1) |
| Biocompatibility - Sensitization | Complied with ISO 10993-10 (in accordance with ISO 10993-1) |
| Biocompatibility - Irritation | Complied with ISO 10993-23 (in accordance with ISO 10993-1) |
| Software Verification and Validation | Complied with FDA Guidance, "Moderate" level of concern |
| Cleaning Validation | Device performance not affected after multiple cleanings |
| Usage Life | > 18 hours typical operation |
| Water Resistance | IP22 Approved |
Note: The SpO2 accuracy of ±2% for the 70-100% range and the Pulse Rate accuracy are specifications, while the ARMS of 1.89% is the result of the clinical performance study. The 1.89% ARMS falls within the generally accepted range for pulse oximeters, which is often considered to be within ±2-3% for this range of SpO2.
Study Details
The primary study proving the device meets its acceptance criteria is a clinical performance study and various performance tests conducted in accordance with international standards.
2. Sample size used for the test set and the data provenance:
- Clinical Performance Study: The study was conducted on healthy, adult volunteers. The specific number of volunteers (sample size) is not explicitly stated in the provided text.
- Data Provenance: The origin of the data is not specified beyond "healthy, adult volunteers." It is a prospective study as indicated by "clinical validation testing... under no motion."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth for pulse oximeters in clinical validation studies does not typically involve human expert consensus on the SpO2 values. Instead, it relies on a co-oximeter (or similar arterial blood gas analysis device), which provides a highly accurate, invasive measurement of arterial oxygen saturation (SaO2). The text states "oxygenated hemoglobin characterization testing" and "clinical validation testing of the SpO2 performance," which implies comparison against a reference method, likely a co-oximeter. Therefore, there is no mention of experts establishing ground truth in this context, nor their specific qualifications.
4. Adjudication method for the test set:
Not applicable for this type of medical device performance testing. Pulse oximeter accuracy is evaluated by comparing the device's readings against a precise, objective reference standard (like a co-oximeter), 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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers interact with the output. The AViTA Pulse Oximeter is a direct measurement device; it does not involve human interpretation of complex data that would be enhanced by AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done. The results presented ("ARMS for SpO2 under no motion was found to be 1.89%") directly reflect the performance of the device's algorithms and hardware in measuring SpO2, without any human interpretation component for the measured value itself.
7. The type of ground truth used:
The type of ground truth used for the clinical performance study, though not explicitly named, would be a highly accurate, invasive arterial oxygen saturation measurement (SaO2) obtained via a co-oximeter. This is the standard reference method for validating non-invasive pulse oximeters. The text refers to "oxygenated hemoglobin characterization testing" which supports this assumption.
8. The sample size for the training set:
Not applicable. The AViTA Pulse Oximeter is a hardware-based device that employs principles of spectrophotometry to mechanically and optically measure SpO2 and PR. While it is "software-driven," it is not described as using machine learning or AI algorithms that would require a distinct "training set" in the conventional sense (e.g., for image classification or prediction). Its algorithms are based on established physiological models of light absorption by blood.
9. How the ground truth for the training set was established:
Not applicable. As noted above, there is no indication of a "training set" for AI/ML models in this context. The core operating principles rely on physics and established physiological relationships.
§ 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).