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The Model 3230 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 digits between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.

Model 3230 Bluetooth® Smart Pulse oximeter is a small, lightweight, portable, digit 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 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 contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate if poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.

Here's a breakdown of the acceptance criteria and study information for the Nonin Model 3230 Pulse Oximeter, based on the provided document:

Acceptance Criteria and Device Performance

Study Information

1. A table of acceptance criteria and the reported device performance: See table above.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Clinical Hypoxia Study: 14 healthy, nonsmoking, light-to-dark-skinned subjects. (Prospective study, conducted in an independent research laboratory; no country of origin specified but likely USA given FDA submission).
• Usability/Human Factors Study: 27 healthy competent adult subjects. (Prospective study; no country of origin specified).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Clinical Hypoxia Study: Not explicitly stated as "experts." Ground truth was established by co-oximeters (laboratory instruments, specifically two Radiometer OSM co-oximeters) which are considered the gold standard for measuring arterial oxygen saturation (SaO2) from blood samples. This is an objective measurement rather than an expert consensus.
• Usability/Human Factors Study: No external experts were used to establish ground truth. The study collected user feedback (self-reported satisfaction) and observed performance (ability to perform tasks like placement, assembly, disassembly, and understanding symbols).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Clinical Hypoxia Study: For the SpO2 values at each blood draw, the samples were run on four (4) co-oximeters, and the SpO2 values were paired with the average of two OSM (Radiometer) co-oximeters. This implies a form of consensus/adjudication using these two primary co-oximeters as reference.
• Usability/Human Factors Study: No adjudication method described for this study, as it involved direct observation of user performance and user-completed questionnaires.

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 comparative effectiveness study was not performed. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data 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 accuracy study (hypoxia study) was a standalone study. The Model 3230 pulse oximeter's readings were compared directly against the co-oximeter measurements without human interpretation influencing the device's output. The device itself performs the measurement and displays the result. The device is intended for direct readings by users rather than feeding into a larger diagnostic workflow requiring human interpretation of its raw data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Clinical Hypoxia Study: The ground truth for oxygen saturation (SaO2) was established by arterial blood samples measured by laboratory co-oximeters. This is an objective and highly accurate physiological measurement, often considered the gold standard for SaO2.
• Usability/Human Factors Study: The ground truth for usability was based on observed user performance (e.g., successful completion of tasks like device placement, assembly, disassembly, symbol comprehension) and user self-reported satisfaction via questionnaires.

8. The sample size for the training set:

• Not applicable / Not explicitly stated. For a pulse oximeter, "training set" typically refers to the data used to develop the algorithms for SpO2 and pulse rate calculation. This information is usually proprietary to the manufacturer's R&D process and is not typically disclosed in 510(k) summaries for such devices, especially when demonstrating substantial equivalence. The focus is on validation against a clinical test set.

9. How the ground truth for the training set was established:

• Not applicable / Not explicitly stated. As mentioned above, details about the development and "training" (if an algorithm uses machine learning in the modern sense) of the pulse oximeter's core measurement algorithm are not provided. The document focuses on the validation of the device's accuracy against a clinical reference standard.

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