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WesperO2 is a finger-worn pulse oximeter in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs and home use.

WesperO2 ("the device") is a pulse oximeter, meant to be worn on the finger of an adult patient over the age of 21. The device is intended for spot checking or continuous collection of functional oxygen saturation of arterial hemoglobin by way of sensing peripheral capillary perfusion ("SpO2") and Pulse Rate. It is intended to be used in the patient's home or in a sleep lab. The device's core technology is based on collecting reflected light from the intact skin of the patient's finger to form Photoplethysmography ("PPG") waveforms. These waveforms can then be used to extract a measurement of SpO2 and Pulse Rate. The sensing component is carried by an electronics assembly, which is comprised of a battery-powered Printed Circuit Board ("PCB"). The electronics assembly is housed inside of a soft, flexible casing, which encapsulates the entirety of the assembly, except for the actual optical front-end of the sensing component, which exposes an array, consisting of two LEDs and a photodiode. The entire assembly is referred to as "the WesperO2 probe." The silicone housing has a "thimble-style" form factor, such that the patient can wear it on their fingertip, with the optical sensor pointed at the pad of their finger. The probe is then meant to create a snug, yet comfortable fit to ensure consistent positioning of the optical sensor throughout the usage period. The probe has a Bluetooth interface through which it sends SpO2 and Pulse Rate measurements to a companion mobile application ("WesperO2 app"), which resides on the patient's mobile device. The application can both record the data and display it in real-time to the patient. Recordings are saved on the mobile device and can be shared later through the application with a healthcare provider over the internet.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

Based on the provided text, the primary study for the WesperO2 focused on standalone performance and did not involve a multi-reader, multi-case comparative effectiveness study with human readers.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size (for SpO2): N=223 (for ARMS calculation). This refers to the number of data points or observations, not necessarily the number of unique subjects.
   • Test Set Sample Size (for Pulse Rate): N=235 (for ARMS calculation).
   • Data Provenance: The text states the study was a clinical study. While the specific country of origin is not explicitly mentioned, it's generally understood that FDA submissions for clinical studies conducted for US market clearance are often performed in North America or under international standards recognized by the FDA. The study was conducted in accordance with ISO 80601-2-61:2019 and FDA-2007-D-0205 guidance, which outlines requirements for clinical performance in adult subjects. The study appears to be prospective as it was conducted for the validation of the WesperO2 pulse oximeter.

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

   • The ground truth for SpO2 accuracy was established by arterial blood sample CO-Oximetry. This is a direct, objective measurement from a laboratory device, not reliant on human expert interpretation.
   • The ground truth for Pulse Rate accuracy was compared to a "Reference Oximeter Pulse Rate." The text does not specify how this reference oximeter's pulse rate ground truth was established, but it would typically be from a validated reference device or ECG.

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

   • Since the ground truth for SpO2 was established by CO-Oximetry and for Pulse Rate by a reference oximeter (or equivalent objective method), human adjudication was not applicable for establishing the primary ground truth.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. The study focused on the accuracy of the device itself (standalone performance) against objective physiological measurements. The device is a measurement tool, not an AI-assisted diagnostic aid for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance study was conducted. The clinical study evaluated the WesperO2 pulse oximeter's accuracy in measuring SpO2 and Pulse Rate against established physiological reference methods.

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

   • SpO2: Arterial blood sample CO-Oximetry (a direct physiological measurement).
   • Pulse Rate: Reference Oximeter Pulse Rate (a measurement from a validated reference device or potentially ECG).

7. The sample size for the training set:

   • The document does not provide information regarding the sample size of a training set. This is typical for medical device submissions that focus on the validation of a commercial product (especially hardware) rather than AI/ML models that would explicitly require a separate training dataset. The WesperO2's core technology is based on photoplethysmography (PPG) waveforms, a well-established principle in pulse oximetry. While there is software, its validation is described in terms of adherence to standards and risk analysis rather than a statistical training-testing split as seen in AI/ML performance studies.

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

   • As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided.

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