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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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The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.

The subject device, MightySat-OTC, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in individuals 18 years and older. The predicate MightySat that was previously cleared under K181956, has the same intended use as the subject device except it is cleared for prescription use only.

The subject device is identical to the predicate with the RRp and PVi parameters have been disabled in the subject device and the labeling has been modified to provide additional information on the role of pulse oximeters for OTC users. There were no hardware changes made to the MightySat Rx (predicate device, K181956) that resulted in the MightySat-OTC. Like the predicate device, the subject device, has the combined function of a pulse oximeter monitor and a reusable sensor. It includes a color display, enclosed by plastic housing, and powered by two alkaline "AAA" batteries. It also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile device application.

Here’s an analysis of the acceptance criteria and study details for the Masimo MightySat-OTC, based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: 39 healthy volunteer subjects.
• Data Provenance: The study was a prospective clinical performance testing conducted in accordance with ISO 80601-2-61. The location of the study is not explicitly stated, but it is a clinical study involving human volunteers. Data includes varying skin pigmentation, measured using the color-based Massey-Martin scale.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth. For pulse oximetry, the ground truth for SpO2 is typically established through arterial blood gas analysis (reference oximeter), usually performed by trained medical professionals, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). For pulse oximetry clinical studies, ground truth is generally obtained directly from standardized reference methods (e.g., CO-oximetry of arterial blood samples), not through expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a reference method for SpO2 and PR accuracy. The document mentions human factors and usability testing to validate user understanding of labeling and device outputs for OTC use, but this is a different type of study than an MRMC comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the primary clinical performance testing for SpO2 and Pulse Rate accuracy appears to be a standalone (algorithm only) evaluation. The device measures and displays physiological signals directly, and the clinical study evaluates the accuracy of these measurements against a reference standard. The "human factors and usability testing" is a separate evaluation of the user interface and labeling for OTC use, not directly related to the algorithm's diagnostic performance with human input.

7. The Type of Ground Truth Used

The ground truth for SpO2 accuracy is based on a reference standard, specifically arterial blood oxygen saturation (SaO2), as implied by the "SaO2 range" in the performance tables. For pulse oximeters, this typically involves drawing arterial blood samples and analyzing them with a laboratory CO-oximeter.

8. The Sample Size for the Training Set

The document does not provide a specific sample size for the training set. It mentions that "the calibration curve has been adjusted to allow for improved accuracy performance, including across different skin pigments and genders." This implies that data was used to train or refine the device's algorithms, but the size and characteristics of that dataset are not detailed in this submission.

9. How the Ground Truth for the Training Set Was Established

The document states that the calibration curve was "adjusted to allow for improved accuracy performance, including across different skin pigments and genders." While it doesn't describe the exact process for establishing ground truth for this internal adjustment/training, it would typically involve similar methods to the clinical validation: comparing the device's readings to arterial blood gas measurements from a diverse population.

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