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The 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 (at least 4 years and older and weighing >15 kg), 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 Nasal Alar 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 Nasal Alar 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 890 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.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets those criteria, according to your defined points.

Device: Nasal Alar SpO2 Sensor (Premarket Notification K171423 for Xhale, Inc.)
Purpose of this 510(k): Expansion of indications to change patient population from a weight of >30 kg to at least 4 years and older and weighing >15 kg. The sensor itself is unchanged from the predicate device (K143216).

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance acceptance criteria are inferred from the predicate device's performance, as the device itself is unchanged and the study is focused on the expanded patient population.

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

• Sample Size for Test Set: Not explicitly stated as a number of volunteer subjects, but the study type is a "controlled desaturation study with healthy volunteers."
• Data Provenance: The study was a "controlled desaturation study," which is typically prospective clinical data. No country of origin is specified, but given the FDA submission, it's highly likely to be conducted in the USA or follow international standards accepted by the FDA. It is a prospective clinical study.

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

• Not applicable for this type of device and study. The ground truth for SpO2 accuracy in desaturation studies is established by simultaneous arterial blood gas measurements, not expert human readers/reviewers.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth (arterial blood gas measurements) does not require expert adjudication.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human interpretation is a key component to be improved. This device is a sensor measuring a physiological parameter.

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

• Yes, performance was effectively assessed in a "standalone" manner, as the device's accuracy was compared against the objective reference standard (arterial blood gas measurements) in the desaturation study. This is an algorithm-only performance assessment in the context of a pulse oximeter sensor.

7. The Type of Ground Truth Used

• Objective Physiological Measurement: The ground truth for SpO2 accuracy was established through a "controlled desaturation study" which, by standard practice in pulse oximetry validation (e.g., as per ISO 80601-2-61), involves simultaneously measuring arterial blood gas (ABG) values (specifically co-oximetry for actual functional oxygen saturation in blood samples) alongside the device's SpO2 readings as subjects' oxygen levels are lowered.

8. The Sample Size for the Training Set

• Not applicable. This is a 510(k) submission for a physical sensor, not an AI/ML algorithm that requires a "training set" in the computational sense. The device itself (the sensor) is unchanged from the predicate. The "study" here is a clinical validation study rather than a machine learning training/testing paradigm.

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

• Not applicable, as there is no "training set" in the context of an AI/ML algorithm here.

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

The Assurance™ Alar 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 Assurance™ Alar Sensor with its associated patient cable, terminates in a DB-9 connector compatible with monitors employing Nellcor OxiSensor II SpO2 technology such as the Nellcor N-395. The sensor utilizes red and IR LED light sources of 660 nm and 890 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.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Testing (Hypoxia Performance): 12 healthy volunteer subjects.
• Data Provenance: The study was a "Controlled desaturation testing," which implies a prospective, controlled clinical study. The country of origin of the data is not explicitly stated, but the context of an FDA submission suggests it was likely performed in the US or under standards accepted by the FDA.

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

• The document mentions "Reference blood samples were drawn from an indwelling arterial catheter and analyzed on a Co-oximeter." This indicates that the ground truth for SpO2 was established through laboratory analysis by a Co-oximeter, which is a highly accurate method for blood gas analysis, rather than expert interpretation of images or other subjective assessments. Therefore, the concept of a "number of experts" for ground truth as might apply to image-based diagnostics is not directly applicable here.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth was established by direct measurement with a Co-oximeter on blood samples, not through expert consensus or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. This submission focuses on a sensor's accuracy compared to a gold standard.

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

• Yes, the hypoxia performance testing describes a standalone evaluation of the device. The sensor was connected to monitors, and the SpO2 values were recorded. The statistical analysis of the data pairs yielded the device's accuracy (Arms) independently, without human interpretation influencing the primary SpO2 measurement recorded by the device.

7. The Type of Ground Truth Used

• The type of ground truth used for SpO2 accuracy was outcomes data/reference standard measurement obtained from Co-oximeter analysis of arterial blood samples (SaO2).

8. The Sample Size for the Training Set

• The document does not report a separate training set size for the Assurance™ Alar Sensor. This device is a pulse oximeter sensor, which typically relies on established biophysical principles and calibration during manufacturing rather than machine learning algorithms that require extensive training data in the same way an AI diagnostic tool would. The accuracy is likely inherent to its design and calibration, not learned from a dataset.

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

• Not applicable, as no training set for a machine learning algorithm is mentioned. The device's operation is based on spectrophotometric principles, not a learned model from a training set.

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