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The Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. It is intended for spot-checking of individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or screening of lung disease, for use in treatment decisions, and should only be used for making heathcare decisions under the advice of a healthcare provider.

Model 3250 Pulse Oximeter is a small, lightweight, portable, battery operated, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate and is intended for over-the-counter use.

The device measures the absorption caused by the pulsation of blood in the vascular bed, which are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display of the device. The LCD also provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by inserting a patient's digit. This simple operation activates the internal circuitry automatically upon application.

The Model 3250 includes a Bluetooth radio to send real time oximeter readings to a host device. The Model 3250 features a Bluetooth LE version 4.0 radio to ease the connectivity setup configuration with options to implement secure connections for the point-to-point data connection. This oximeter uses ISP3, Nonin's core signal processing technology software.

Acceptance Criteria and Device Performance Study for Nonin OTC Pulse Oximeter Model 3250 (K211498)

The Nonin OTC Pulse Oximeter Model 3250 is intended for measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate in individuals under no motion conditions for over-the-counter medical use. The device's performance was evaluated through clinical and non-clinical testing to ensure compliance with relevant standards and demonstrate substantial equivalence to predicate and reference devices.

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the pulse oximeter's accuracy is based on the ISO 80601-2-61:2017 standard, which specifies an ARMS (Accuracy Root Mean Squared) of ≤ 3.0%. The device's performance was assessed across different SaO2 ranges and skin pigmentations.

The reported device performance consistently falls within the 3.0% ARMS guidance, demonstrating the device meets the accuracy acceptance criteria across various SaO2 ranges and skin pigmentations. The bias values also indicate no clinically significant bias.

2. Sample Sizes and Data Provenance

The clinical performance testing utilized data from two studies:

• Leeb Study:
  • Sample Size (Test Set): 34 participants.
  • Data Provenance: Not explicitly stated, but it is an "independent study." Controlled desaturation study.
• UCSF Study:
  • Sample Size (Test Set): 26 participants.
  • Data Provenance: Conducted at UCSF (University of California, San Francisco). Controlled desaturation study.

Both studies involved "controlled desaturation studies with arterial oxygen saturation (SaO2) plateaus between 70% and 100%," suggesting a prospective clinical study design where participants' oxygen levels were intentionally varied under medical supervision. The text emphasizes "diverse skin pigmentation" in both studies, indicating an effort to include a representative demographic.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. For pulse oximeter accuracy studies using controlled desaturation, the ground truth for arterial oxygen saturation (SaO2) is typically established through co-oximetry measurements of arterial blood samples, which are analyzed by laboratory professionals using specialized equipment. This process does not usually involve subjective expert interpretation in the same way, for example, a radiology image would.

4. Adjudication Method

The document does not describe an adjudication method for the test set. In pulse oximetry accuracy studies, the direct comparison is between the device's SpO2 readings and the established SaO2 ground truth (from co-oximetry). There isn't typically an expert panel review or adjudication process for interpreting the ground truth data itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed for the Nonin Model 3250 or its reference device. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. Pulse oximetry device validation focuses on the accuracy of the device's direct measurement against a physiological gold standard.

6. Standalone (Algorithm Only) Performance

The study primarily evaluates the standalone performance of the pulse oximeter device, which integrates the sensor and the algorithm. The text states: "Nonin oximeters utilize the same oximeter technology thus the accuracy of Model 3250 is identical to the results of the reference device, Model 3230" and "The optical path and algorithm for the Model 3250 is equivalent to the Model 9590." This indicates that the performance data presented directly reflects the algorithm's capability as integrated into the device, without a human-in-the-loop component for interpreting the raw signal.

7. Type of Ground Truth Used

The ground truth used for the clinical accuracy studies (Leeb and UCSF studies) was arterial oxygen saturation (SaO2) measured from arterial blood samples (co-oximetry). This is considered the gold standard for determining actual arterial oxygen saturation. The studies are described as "controlled desaturation studies," confirming the use of direct physiological measurement for ground truth.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The clinical data presented is for validation (test set) of the device's accuracy. For pulse oximeters, the core signal processing technology (ISP3 for Nonin) is likely developed and refined over time using extensive proprietary datasets, but specific "training set" details for a machine learning model are not typically disclosed or relevant in the same way as for AI software devices. The statement "Nonin oximeters utilize the same oximeter technology" and "The optical path and algorithm for the Model 3250 is equivalent to the Model 9590" suggests leveraging existing, established technology rather than a newly trained AI model.

9. How Ground Truth for the Training Set Was Established

As with the training set sample size, the document does not detail how the ground truth for any presumed "training set" for the underlying "ISP3" signal processing technology software or core algorithm was established. Given the nature of pulse oximetry, it's highly probable that any developmental data would similarly rely on arterial oxygen saturation (SaO2) measured from arterial blood samples (co-oximetry), following the established methodology for validating pulse oximeter accuracy.

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