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The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated and deoxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.

The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are lightemitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood.

As part of the reprocessing manufacturing process, we collect used devices from hospitals, replace required components, clean the devices and test the functional performance of the devices to ensure they meet or exceed requlatory requirements and the expectations of our customers.

The provided text describes the 510(k) summary for reprocessed pulse oximeter sensors. It outlines the device, its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence.

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

Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set (Clinical Validation - SpO2 Accuracy): Healthy, adult volunteers. The exact number of volunteers is not specified in the provided text.
   • Data Provenance: The text states, "Stryker Sustainability Solutions performed the clinical validation testing of the SpO2 performance under no motion conditions on healthy, adult volunteers." This indicates it was a prospective study conducted by the applicant. The country of origin is not explicitly stated but is implicitly within the regulatory scope of the US FDA.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • The document describes the device performance (SpO2 accuracy and pulse rate), which is measured against an established standard (ISO 80601-2-61:2011 and FDA guidance), rather than establishing a "ground truth" through expert consensus for diagnostic purposes.
   • For a pulse oximeter, the ground truth for SpO2 accuracy is typically established by co-oximetry blood gas analysis, performed by trained laboratory personnel, not by subjective expert interpretation. The text does not elaborate on how exactly the "ground truth" reference values for SpO2 were obtained during the clinical validation, only that the A_rms values were calculated for the device's performance.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of a pulse oximeter accuracy study. The assessment is quantitative (numerical measurement vs. reference).

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. This is a study for a medical device (pulse oximeter sensor), not an AI-based diagnostic imaging tool. Therefore, MRMC studies and "human readers" are not relevant to this submission.

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

   • Yes, in a sense. The SpO2 accuracy and pulse rate accuracy measurements are characteristics of the device itself (sensor and its interaction with a console). The stated A_rms values reflect the device's intrinsic performance against a reference standard. While the device requires a human (patient) to apply it and a human (clinician) to interpret the readings, the performance metrics are fundamentally about the sensor's ability to accurately measure physiological parameters.

6. The type of ground truth used:

   • For SpO2 accuracy, the ground truth is typically measured physiological parameters obtained from a reliable reference method, usually a co-oximeter (invasive arterial blood gas analysis), which is considered the gold standard for SpO2. The text states the study was conducted on healthy volunteers in a hospital setting, which is consistent with such an approach, though the explicit method of ground truth establishment is not detailed beyond the discussion of A_rms as per ISO standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a "training set" in the conventional sense. The "training" for this reprocessed device is ensuring that the reprocessing manufacturing process allows it to function equivalently to the original device.

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

   • Not applicable, as there is no "training set" in the context of this device. The validation process involves demonstrating that the reprocessed device performs according to established safety and effectiveness standards, similar to a new device or its predicate.

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