(30 days)
The Nonin® Onyx II® Model 9560 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 of patients who are well or poorly perfused. 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 9560 is a small, lightweight, portable finger pulse oximeter with Bluetooth® communication which can be integrated into a telemedicine system or other health data collection system through the wireless connection. The device 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 emitting 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 Model 9560 uses 2 "AAA" disposable alkaline batteries for power, which shall provide 600 spot-checks. The 9560 requires no routine calibration or maintenance other than replacement of the alkaline batteries.
The provided text from K081285 describes a 510(k) submission for the Nonin Onyx II Model 9560 Finger Pulse Oximeter. While it states that the device "has successfully undergone both bench and human testing to support the determination of substantial equivalence," it does not provide explicit acceptance criteria or detailed study results and methodologies to definitively prove the device meets specific acceptance criteria. The document focuses on establishing substantial equivalence to predicate devices based on accuracy, functional design, and operating principles.
However, based on the context of pulse oximeter submissions, we can infer typical acceptance criteria and study types. I will construct an answer assuming standard practices for pulse oximeter submissions, explaining where information is explicitly stated and where it is inferred.
Inferred Acceptance Criteria for Pulse Oximeters based on FDA Guidance:
For pulse oximeters, key performance metrics typically involve accuracy for oxygen saturation (SpO2) and pulse rate (PR).
- SpO2 Accuracy: Often, the accuracy requirement for SpO2 is expressed as the Root Mean Square (RMS) difference between the oximeter reading and a reference standard (e.g., arterial blood gas co-oximetry). A common range for this is ≤ 3% ARMS (Accuracy Root Mean Square) across the specified SpO2 range (e.g., 70-100%).
- Pulse Rate Accuracy: Similarly, pulse rate accuracy is typically assessed against an ECG reference. A common requirement is ± 3 bpm (beats per minute).
Study and Performance Details from the Provided Text (and inferred standards):
Given the limitations of the provided document, the table below will combine explicitly stated information with common expectations for pulse oximeter 510(k) submissions.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Inferred from industry standards/FDA guidance) | Reported Device Performance (Inferred from "substantially equivalent" claim) |
|---|---|---|
| SpO2 Accuracy | ≤ 3% ARMS (Accuracy Root Mean Square) for SpO2 70-100% | Performance comparable to predicate devices (K053130, K043359), implying it meets or exceeds this criterion. (Not explicitly stated in numbers). |
| Pulse Rate | ± 3 bpm | Performance comparable to predicate devices, implying it meets or exceeds this criterion. (Not explicitly stated in numbers). |
| Functional Equivalence | To operate safely and effectively, providing SpO2 and PR readings for well or poorly perfused patients. | "substantially equivalent to the predicate devices in terms of accuracy, functional design and principles of operation." |
| Safety | No new questions of safety raised compared to predicate devices. | "Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed devices." |
Note: The document explicitly states "Nonin's Model 9560 Finger Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence." This implies that the device met internal acceptance criteria for these tests, which would align with the inferred clinical accuracy requirements for pulse oximeters. However, the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. For clinical accuracy studies of pulse oximeters, the FDA typically recommends a minimum of 10 healthy adult subjects in a desaturation study to obtain sufficient data points across the hypoxic range (70-100% SpO2).
- Data Provenance: The document does not specify the country of origin of the data. It states "human testing," which usually implies prospective clinical studies where subjects are enrolled and data collected for the specific purpose of the device evaluation. There is no indication of retrospective data use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not explicitly stated. For pulse oximeter accuracy studies, ground truth for SpO2 is typically established using a laboratory co-oximeter to analyze arterial blood samples, not through expert review of data. For pulse rate, an ECG machine provides the ground truth.
- Qualifications of Experts: N/A for establishing SpO2/PR ground truth in this context. Medical professionals (e.g., anesthesiologists, nurses) would oversee the subject desaturation protocol and blood draws, but they are not "experts" establishing a consensus ground truth like in image interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used when subjective interpretations are involved, such as in clinical trials requiring event confirmation or in diagnostic imaging studies where multiple readers interpret images to establish a consensus ground truth. For pulse oximeter accuracy, the ground truth is objective (co-oximetry and ECG), so no adjudication of device readings or reference measurements is needed in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, not applicable. MRMC studies are designed for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret cases (e.g., medical images) to diagnose conditions, and the study evaluates the impact of an AI algorithm on their performance. The Nonin Onyx II Model 9560 is a direct measurement device; it does not involve human interpretation of complex "cases" that an AI would assist with. Therefore, an MRMC study is not relevant for this type of device.
- Effect Size of Human Readers with/without AI assistance: N/A, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The core "human testing" mentioned for a pulse oximeter involves directly comparing the device's readings (SpO2 and pulse rate) against the objective reference standards (arterial blood gas co-oximetry for SpO2 and ECG for pulse rate). This is a standalone evaluation of the device's algorithm and sensor performance in producing accurate readings. The device is designed to display these measurements directly, not to provide an AI-driven interpretation that then guides a human.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- For SpO2: Arterial blood gas co-oximetry. This is the gold standard for determining arterial oxygen saturation (SaO2), against which pulse oximeters' SpO2 readings are compared.
- For Pulse Rate: Electrocardiogram (ECG). An ECG provides an accurate measure of heart rate, which serves as the reference for the pulse oximeter's pulse rate measurement.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not explicitly stated. The document describes a traditional medical device (pulse oximeter) that uses fixed algorithms and signal processing, not a machine learning or AI-based algorithm that typically requires a distinct "training set" in the common sense. Therefore, the concept of a separate training set, as understood in AI/ML, doesn't directly apply here. The device's algorithms are likely developed and refined using engineering principles and historical physiological data rather than a specific "training set" for a submission study.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable. As explained above, for this type of device, a "training set" as commonly defined in AI/ML is not relevant. The device's underlying physiological models and calibration would have been established through extensive research and development, likely using various physiological data and established scientific principles, rather than a single "training set" with an explicitly established ground truth for regulatory purposes.
§ 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).