(283 days)
Mediaid's compatible sensors are indicated as accessories to pulse oximeters used on Pulse Oximeters manufactured by Nonin Inc for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients.
Mediaid 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 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 adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 connector.
The Mediaid SpO2 Sensors are intended for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The device's performance was evaluated through clinical hypoxia studies and bench testing.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Equivalent to predicate device accuracy claims | Found to be equivalent to predicate device accuracy claims |
| Pulse Rate Accuracy | Demonstrated through bench testing | Bench testing was performed to verify pulse rate accuracy |
| Biocompatibility | Conformance with established industry standards | Performed to demonstrate conformance with established industry standards |
| Electrical Safety | Conformance with established industry standards | Performed to demonstrate conformance with established industry standards |
| EMC Testing | Conformance with established industry standards | Performed to demonstrate conformance with established industry standards |
Note: The document states "equivalent to predicate device accuracy claims" for SpO2 accuracy, but it does not explicitly state numerical acceptance criteria for SpO2 or pulse rate. It implies that the predicate device's accuracy claims serve as the benchmark.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies" without providing the number of subjects.
- Data Provenance: Clinical hypoxia studies were conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective, as they are described as "conducted" for the purpose of the device's evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The ground truth for SpO2 measurements was established using "arterial blood samples analyzed on a laboratory co-oximeter." The expertise of those analyzing the co-oximeter results is not detailed.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for SpO2 was derived from objective measurements (laboratory co-oximetry of arterial blood samples), not from expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The evaluation focuses on the device's performance against a reference standard (co-oximetry) and predicate device equivalence, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done for the SpO2 sensor. The "clinical hypoxia studies" evaluated the Mediaid SpO2 sensors against arterial blood samples analyzed on a laboratory co-oximeter, demonstrating the algorithm's (sensor's) ability to measure SpO2 directly. Bench testing was also performed solely on the device to verify pulse rate accuracy.
7. Type of Ground Truth Used
- SpO2: Objective measurement from "arterial blood samples analyzed on a laboratory co-oximeter."
- Pulse Rate: Not explicitly stated, but likely derived from a validated reference method during bench testing.
8. Sample Size for the Training Set
Not applicable. The document describes a medical device (SpO2 sensor) rather than an AI-powered diagnostic algorithm that typically requires a distinct training set. The device's operation is based on established electro-optical principles, not on machine learning requiring a training phase with labeled data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific training set for an AI/ML algorithm described.
§ 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).