(196 days)
EnviteC Reusable SpO2 Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments.
The EnviteC Reusable SpO2 Sensors type Nihon Kohden are pulse oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturer.
EnviteC's Reusable SpO2 Sensors type Nihon Kohden are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Two types of sensor housings are offered in this submission:
- A soft rubber finger sensor with unitary sealed tube type construction (two sizes: large and medium)
- An ear clip with rigid halves positioned by mild spring force and an ear hanger for the cable
Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer.
Each sensor type includes the following features:
- Connector pin-outs specific for the manufacturer type
- Component specifications specific for the manufacture type
Each sensor clearly specifies the manufacturer type with two compatibility statements:
- One printed on or attached to the sensor
- One on the instructions for use.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only explicitly states that "All sensors met the acceptance criteria" for non-clinical tests and that "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2." However, it does not provide the specific numerical acceptance criteria for SpO2 accuracy or other performance metrics. Without these, a detailed table cannot be created.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Specific numerical acceptance criteria for SpO2 accuracy are not provided in the text.) | Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2. |
| (Specific acceptance criteria for pulse rate accuracy are not provided in the text.) | Sensors (with predicate device monitors) were tested for pulse rate with a listed simulator, and all sensors met the acceptance criteria. |
| (Specific acceptance criteria for electro-optical parameters are not provided in the text.) | Sensor electro-optical parameters were compared to predicate devices, and all sensors met the acceptance criteria. |
| Compliance with electrical safety and electromagnetic compatibility standards. | Sensors were tested in accordance with current applicable standards for medical device electrical safety and electromagnetic compatibility, and all sensors met the acceptance criteria. |
| Biocompatibility of patient contact materials. | Sensor patient contact materials meet applicable standards for biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
The text states that "Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable SpO2 Sensors type Nihon Kohden under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry."
- Sample Size for Test Set: Not explicitly stated. The text mentions "subjects," but no number is provided.
- Data Provenance: Not explicitly stated, but the testing was performed "under an institutionally approved protocol with subject informed consent," suggesting a prospective clinical study. The country of origin is not specified, though the submitter is from Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, the ground truth was "determined by cooximetry," which is a laboratory method, not typically established by clinical experts in the same way, for example, diagnosing an image. The cooximetry results themselves would serve as the objective ground truth.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by cooximetry, an objective measurement, not by expert consensus requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described focuses on the direct accuracy of the device against an objective measurement (cooximetry), not on human reader performance with or without AI assistance.
- Effect size of human readers improvement: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The clinical testing described directly assesses the sensor's performance ("performance and accuracy of the EnviteC Reusable SpO2 Sensors") against an objective ground truth (arterial oxygen saturation determined by cooximetry). This is a direct test of the device's accuracy without a human in the loop for interpretation or intervention.
7. Type of Ground Truth Used
The ground truth used was cooximetry, which provides an objective measurement of arterial oxygen saturation (SaO2).
8. Sample Size for the Training Set
Not applicable. The device is a medical sensor (SpO2 sensor), not an AI algorithm that requires a training set. The "training" in this context would refer to calibration or manufacturing parameters, not a data-driven machine learning step.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the AI/machine learning sense for this type of 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).