(24 days)
Finger sensor: The Finger sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
Ear sensor: The Ear sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg.
Neonatal-Adult sensor: The Neonatal-Adult sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
Adult/Pediatric Sensor: The Adult/Pediatric sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
SpO2 sensors are electro-optical sensors that function 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 body contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The sensor body is connected to a cable that is terminated with a 9-pin D-connector for connecting the sensor to a patient monitor or an interconnect cable.
The Finger and Ear sensors are durable, multiple-patient-use sensors. The sensor structure has a spring structure that easily and comfortably accomodates the sensor to the application site. The Neonatal-Adult and Adult/Pediatric sensors are disposable single-patient-use sensors. The attachment mechanism of these sensors is a soft adhesive tape that is wrapped around the application site.
This document describes the performance testing for SpO2 sensors (Finger, Ear, Neonatal-Adult, and Adult/Pediatric) for use with Nellcor® R-Cal SpO2.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy (over 70-100% SpO2 range) | ±3 digits |
| Pulse Rate Measurement Accuracy | Verified through bench testing with a simulator |
| Patient Interface Temperature | Not higher than for predicate devices |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated, but the study involved "healthy adult volunteer subjects" for the induced hypoxia studies.
- Data Provenance: Retrospective, as indicated by the description of already conducted "induced hypoxia studies." The studies were conducted in an "independent research laboratory" but the country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable. The ground truth for SpO2 accuracy was established through direct measurement against a laboratory co-oximeter, not through expert consensus.
4. Adjudication Method for Test Set
Not applicable, as the ground truth for SpO2 accuracy was established by a laboratory co-oximeter, not through expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done as part of this submission for the SpO2 sensors. The testing focused on the standalone performance of the device.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was conducted for the SpO2 sensors. The SpO2 accuracy and pulse rate accuracy were evaluated based on the device's measurements compared to a reference standard (co-oximeter for SpO2, simulator for pulse rate).
7. Type of Ground Truth Used
- SpO2 Accuracy: Arterial hemoglobin oxygen value determined from blood samples using a laboratory co-oximeter.
- Pulse Rate Accuracy: Reference values provided by a simulator.
8. Sample Size for Training Set
The document does not explicitly mention a separate "training set" or its sample size. The testing described focuses on validation/performance evaluation rather than algorithm training.
9. How Ground Truth for Training Set Was Established
Not applicable, as a distinct training set for an algorithm is not described in this document. The document refers to validation tests, implying these sensors are electro-optical in nature and their performance is evaluated directly rather than through a machine learning model that would require a training set.
§ 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).