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The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.

The Flexi-Site SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a durable silicone casing. The sensor cable is terminated in a Hypertronics style connector.

Here is an analysis of the provided text regarding the acceptance criteria and the study that proves the Flexi-Site SpO2 Ear Sensor meets those criteria:

Device Acceptance Criteria and Performance

While the document explicitly states the "Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2", it does not provide a pre-defined acceptance criterion for this metric. The listed value of 3.84% is simply the result obtained from the performance testing. In a typical regulatory submission, there would be a target accuracy value (e.g., "Accuracy Ams shall be less than 4%"). However, based on the provided text, the 3.84% value implicitly met the FDA's unstated or assumed requirements for substantial equivalence to the predicate devices.

Study Details

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

   • Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies," but does not provide the number of subjects or data points included in these studies.
   • Data Provenance: The studies were "clinical hypoxia studies conducted in an independent research lab." While the country of origin is not specified, clinical hypoxia studies typically involve human subjects whose oxygen levels are carefully controlled. The phrasing "clinical hypoxia studies" implies a prospective study design where data was collected specifically for this purpose.

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

   • Number of Experts: Not applicable. The ground truth was established by laboratory co-oximetry, not by expert consensus.
   • Qualifications of Experts: Not applicable.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. The ground truth was established by direct comparison to arterial blood samples analyzed on a laboratory co-oximeter, a gold standard measurement, which does not typically involve expert adjudication in the same way imaging or subjective diagnostic tasks might.

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:

   • MRMC Study: No. This device is an SpO2 sensor, which provides automated measurements, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
   • Effect Size: Not applicable.

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

   • Standalone Performance: Yes, implicitly. The performance data presented (Accuracy Ams of 3.84%) refers to the device's measurement accuracy compared to a reference standard, without any explicit mention of human interpretation or intervention in the measurement process itself. The SpO2 sensor is an automated measurement device.

6. The type of ground truth used:

   • Ground Truth Type: Arterial blood samples analyzed on a laboratory co-oximeter. This is considered a gold standard for blood oxygen saturation measurement.

7. The sample size for the training set:

   • Sample Size: Not applicable. As an electro-optical sensor, the device's operation is based on established physical principles for light absorption by hemoglobin. It's not a machine learning or AI device that requires a training set in the conventional sense. Its "training" is in its design and calibration, not in learning from a large dataset.

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

   • Ground Truth Establishment: Not applicable, as no training set was used in the machine learning sense. The device's fundamental operating principles and calibration would be based on well-understood physiological and optical science.

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The additional Masimo series of sensors are intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The following additional Masimo Sensors are indicated for the continuous noninvasive function of arterial hemoglobin (SpO2) and pulse rate:

Single use oximetry sensor intended for adults and pediatrics greater than 10 kg
Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg
Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg

The Masimo series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.

Here's a summary of the acceptance criteria and study information for the Masimo series of oximetry sensors, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported accuracy (Arms) for different sensors and patient populations. The document states a target range of 70% to 100% SaO2 for these accuracy figures.

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

• Sample Size: Not explicitly stated beyond "adult volunteers."
• Data Provenance: The study was conducted on "adult volunteers." No specific country of origin is mentioned, but the company is based in Irvine, CA, USA, suggesting the study was likely conducted in the US. The study appears to be prospective, as it involved performance testing on volunteers.

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

Not applicable. The ground truth was established through direct measurement (arterial blood samples), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established through direct measurement (arterial blood samples).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. This device measures physiological parameters.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Yes, a standalone performance study was done. The "Performance Data and Conclusions" section describes the device's accuracy by comparing its readings to arterial blood samples, which is a standalone evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used was arterial blood sampled. This refers to direct measurement of oxygen saturation from arterial blood.

8. Sample Size for the Training Set

Not applicable. The document describes a performance validation study, not the development or training of a machine learning algorithm.

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

Not applicable as there is no mention of a training set for a machine learning algorithm.

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