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The Assurance™ Nasal / Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (weighing > 30kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.

The Alar / Nasal SpO2 Sensor is a disposable, single patient use Pulse Oximetry sensor designed to attach to the patient's nasal alar region - the fleshy region at the side of the nose. Skin contact and adhesive free sensor retention is via soft silicone rubber cushions encapsulating the optical components. The Alar / Nasal SpO2 Sensor with its associated patient cable, terminates in a DB-9 connector compatible with monitors employing Nellcor SpO2 technology.

The sensor utilizes red and IR LED light sources of 660 nm and 880 nm respectively along with a silicon photodiode detector to detect changes in oxygen saturation in the blood. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.

The provided document describes the Assurance™ Alar / Nasal SpO2 Sensor. Here's a breakdown of the acceptance criteria and study information:

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

Note: The SpO2 A_RMS for the proposed device and one of the predicate devices is listed as ± 3%. However, elsewhere in the document, the predicate Xhale Alar SpO2 sensor is listed with an A_RMS of 70-100% ± 2%. The document specifically emphasizes that the proposed device's performance within ± 3% meets the ISO 80601-2-61 standard, which allows for this range.

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

• Sample Size for Test Set (Clinical Testing):
  • The "Clinical Testing" section mentions a "controlled desaturation study with healthy volunteers."
  • The table detailing SpO2 Accuracy for different oximetry platforms shows varying "pts" (points or patients) for each platform, ranging from 257 pts to 279 pts. It's unclear if "pts" refers to individual volunteers or data points. Given the context of a desaturation study with healthy volunteers, it likely refers to subjects, or instances of data collection from subjects. The overall study used healthy volunteers.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the nature of a "controlled desaturation study with healthy volunteers" implies a prospective design.

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. The study involves a controlled desaturation study where arterial blood gas measurements (or a similar reference method) would typically establish the true SpO2. The ground truth for SpO2 measurements in such studies is usually derived from a co-oximeter analyzing arterial blood samples, not from expert interpretation of images or other data.

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

This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or data where there might be inter-reader variability in interpreting findings. For a pulse oximeter, the ground truth for SpO2 is a quantitative measurement, usually from a laboratory gold standard (e.g., co-oximetry of arterial blood), not subject to expert adjudication.

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

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a medical sensor, not an AI-powered diagnostic tool requiring human reader interpretation.

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

This refers to the performance of the device itself (the sensor and its underlying algorithm) in measuring SpO2. The "Clinical Testing" section describes a controlled desaturation study where the device's SpO2 accuracy (A_RMS) was measured against a reference standard. This is essentially a standalone performance test for the algorithm within the device. The results are reported as A_RMS values for the device with various compatible monitors.

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

The ground truth for the clinical SpO2 accuracy study would have been established by a reference co-oximeter performing arterial blood gas analysis, which is the gold standard for measuring arterial oxygen saturation. The document mentions "controlled desaturation study," which is the standard methodology for assessing SpO2 accuracy against a highly accurate reference.

8. The sample size for the training set

This information is not provided and is likely not applicable in the context of this 510(k) submission. Pulse oximeters operate on well-established spectrophotometric principles, and their algorithms are typically designed based on physics and physiological models, rather than trained on large datasets in the way that machine learning models are. If any calibration or tuning was done, the details are not disclosed as a "training set."

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

As there's no mention of a traditional "training set" for a machine learning model, this information is not applicable. The device's operation is based on fundamental principles of light absorption by oxygenated and deoxygenated hemoglobin.

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