(326 days)
The sensor is indicated for single patient use for continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
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 light-emitting 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.
The proposed devices of this submission do not differ from the predicate device. The only difference is that the proposed devices will be exposed to vaporized hydrogen peroxide for sterilization instead of ethylene oxide.
This document describes the validation of a reprocessed pulse oximeter sensor. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| SpO2 ARMS (woven tape) | Not explicitly stated but inferred to be clinically acceptable and comparable to predicate. | 1.62% (over 70-100% SpO2 range) |
| SpO2 ARMS (non-woven tape) | Not explicitly stated but inferred to be clinically acceptable and comparable to predicate. | 1.56% (over 70-100% SpO2 range) |
| Functional (Continuity) | Pass | Passed |
| Functional (Sensitivity) | Pass | Passed |
| Biocompatibility | Meet ANSI/AAMI/ISO 10993-1: 2009 | Met |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the number of healthy adult volunteers involved in the clinical validation testing.
- Data Provenance: The clinical validation testing was performed by Stryker Sustainability Solutions. The country of origin of the data is not specified but is presumably where the company operates or sponsored the study. The study was prospective as it involved clinical validation testing on healthy adult volunteers.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a ground truth for the test set. The clinical validation focused on direct measurement of SpO2 and pulse rate.
4. Adjudication Method for the Test Set:
Not applicable, as no external adjudication method is described for defining the ground truth in the clinical validation. The SpO2 and pulse rate measurements are direct physiological measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key component. The pulse oximeter sensor provides direct physiological measurements.
6. Standalone (Algorithm Only) Performance Study:
Yes, a standalone performance study was done through:
- Non-clinical bench simulation testing: This involved using a stand-in device for SpO2 sensor verification. These tests (continuity and sensitivity) assess the device's functional performance independently.
- Clinical validation testing: This directly assessed the device's ability to measure SpO2 and pulse rate on healthy adult volunteers, which represents the algorithm's performance in a real-world scenario without human interpretation.
7. Type of Ground Truth Used:
- Clinical Validation: The ground truth for SpO2 measurements in the clinical validation would typically be established by a co-oximeter or other reference method for arterial oxygen saturation, though this is not explicitly detailed in the provided text. The output of the device itself (SpO2 and pulse rate) is a direct measure against implied physiological norms or a gold standard measuring device.
- Bench Testing: The ground truth for continuity and sensitivity testing is based on engineered specifications and the expected electrical and optical behavior of the sensor.
8. Sample Size for the Training Set:
This information is not provided in the document. The device is a reprocessed sensor, and the validation focuses on verifying the performance of the reprocessed device against its original specifications and predicate devices. It doesn't describe an AI/ML algorithm development process that typically involves a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided as the document does not detail an AI/ML algorithm requiring a training set. The validation is for a reprocessed medical device.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).