(30 days)
The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site.
The Model 9550 Onyx® II is a small, lightweight, portable, finger pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light omitting diodes (LEDs) are contained within the sensor along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and heart rate are displayed on the LED digital displays contained within the finger clip sensor. A tricolor LED display provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to alert you to changes in pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates as inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by inserting a patient's finger. This allows the power to be applied to all the internal circuitry upon activation. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.
This document describes the acceptance criteria and study used to demonstrate the performance of the Nonin Medical, Inc. Onyx® II Model 9550 Finger Pulse Oximeter.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria with specific thresholds for accuracy or precision of SpO2 and pulse rate measurements. However, it indicates that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." The conclusion states that the device "is substantially equivalent to the predicate devices in terms of accuracy, functional design and principles of operation," implying that its performance meets comparable levels to the predicate device, the Model 9500 Onyx® Finger Pulse Oximeter (K001085).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to accuracy specifications for SpO2 | Human oxygenation evaluations confirmed conformance to accuracy specifications. |
| Conformance to precision specifications for SpO2 | Human oxygenation evaluations confirmed conformance to precision specifications. |
| Conformance to accuracy specifications for Pulse Rate | Human oxygenation evaluations confirmed conformance to accuracy specifications. |
| Conformance to precision specifications for Pulse Rate | Human oxygenation evaluations confirmed conformance to precision specifications. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of human subjects or data points used in the "human oxygenation evaluations."
- Data Provenance: The document does not explicitly state the country of origin. It indicates "human testing to support the determination of substantial equivalence." Given the submitter (Nonin Medical, Inc.) is based in Plymouth, MN, USA, it is highly probable the data was collected in the USA. The study was prospective, as it involved human oxygenation evaluations specifically conducted to confirm conformance to specifications for this new device.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This device is a pulse oximeter which directly measures physiological parameters (SpO2 and pulse rate). Ground truth for such devices is typically established through a reference method, not expert consensus on interpretations. The ground truth for oxygen saturation would likely be based on an arterial blood gas analyzer.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study is based on direct physiological measurements against a reference standard, not interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a standalone diagnostic tool, not an AI-assisted interpretation system for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "human oxygenation evaluations" were conducted to assess the performance of the device itself (algorithm only) in measuring SpO2 and pulse rate against reference standards. The document explicitly states, "Functional and Safety Testing: Nonin's Onyx® II Model 9550 Finger Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications."
7. Type of Ground Truth Used
The ground truth for the "human oxygenation evaluations" was almost certainly a reference method for blood oxygen saturation and pulse rate measurement, such as direct arterial blood gas analysis for oxygen saturation and an ECG or manual pulse check for pulse rate. The term "human oxygenation evaluations" strongly implies a comparison against a more invasive and accurate reference standard.
8. Sample Size for the Training Set
Not applicable. Pulse oximeters are typically developed based on established physiological principles and algorithms, not through machine learning models requiring a "training set" in the common AI sense. The algorithms are built upon physics of light absorption and blood pulsation.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the machine learning context for this type of device. The underlying principles and algorithms are based on established physiological and engineering principles.
§ 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).