(64 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 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 Onyx® II Model 9550 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.
The provided text is a 510(k) summary for the Onyx® II Model 9550 Finger Pulse Oximeter. It unfortunately lacks detailed information regarding specific acceptance criteria for performance metrics and the associated study data that would directly "prove" the device meets them in the way requested. This document primarily focuses on establishing substantial equivalence to a predicate device.
However, based on what is available, I can extract and infer some information, particularly around the "Functional and Safety Testing" section:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Nonin's Model 9550 Finger Pulse Oximeter has successfully undergone bench testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device." While specific numerical acceptance criteria are not provided, the implied acceptance criterion is "has appropriate functional features and is substantially equivalent to the predicate device." The reported performance is that the device "successfully undergone bench testing" and meets this criterion.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Device has appropriate functional features and is substantially equivalent to the predicate device. | Successful completion of bench testing, demonstrating appropriate functional features and substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The summary refers to "bench testing" but does not give numerical sample sizes for any performance testing.
- Data Provenance: Not explicitly stated. However, "bench testing" typically implies laboratory or controlled environment testing, not necessarily clinical data with geographic provenance. It's likely prospective for the specific tests conducted for this submission.
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. Oximeters typically rely on direct comparison to arterial blood gas analysis (co-oximetry) for accuracy, which wouldn't involve "experts" establishing ground truth in the same way an imaging study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Given the nature of oximetry testing, an adjudication method for ground truth establishment as typically seen in image interpretation studies is not usually applicable.
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, an MRMC study was NOT done. This device is a pulse oximeter, not an AI-assisted diagnostic imaging tool. Therefore, the concept of "human readers improve with AI" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. A pulse oximeter operates as a standalone device, providing SpO2 and pulse rate readings directly. The "bench testing" mentioned would assess the algorithm's accuracy in calculating these values against a reference standard. There is no explicit "human-in-the-loop" component for interpretation of the raw data by the end-user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While not explicitly stated for this specific submission, the industry standard for establishing ground truth for pulse oximeters is typically co-oximetry (arterial blood gas analysis). This involves simultaneous measurement of SpO2 by the device and a laboratory co-oximeter from an arterial blood sample.
8. The sample size for the training set:
- Not applicable. This device is not described as involving machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See point 8.)
§ 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).