(184 days)
The additional Masimo series of sensors are intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospital-type facilities, mobile, and home environments.
The following additional Masimo Sensor is indicated for the continuous noninvasive functional of arterial hemoglobin (SpO2) and pulse rate:
Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospitals, hospital-type facilities, mobile, and home environments.
The Masino series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.
- Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Arms) for SpO2 | ± 2.0% SpO2 |
-
Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated, but the performance testing was conducted on "adult volunteers."
- Data Provenance: The data was collected prospectively from "adult volunteers." The country of origin is not specified but implicitly the US, given the submission to the FDA.
-
Number of Experts and Qualifications for Ground Truth:
- No information provided regarding experts. The ground truth was established by comparing the device's measurements to arterial blood samples analyzed on a laboratory CO-Oximeter, which is a recognized gold standard for oxygen saturation in medical contexts.
-
Adjudication Method for the Test Set:
- Not applicable as the ground truth was derived from a laboratory instrument (CO-Oximeter) rather than human adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This study is about a medical device's accuracy in measuring physiological parameters, not about human readers' performance with or without AI assistance.
-
Standalone Performance (Algorithm only):
- Yes. The study assessed the standalone performance of the LNOP-TF-I sensor by directly comparing its readings to a laboratory CO-Oximeter.
-
Type of Ground Truth Used:
- The ground truth was established using arterial blood samples analyzed on a laboratory CO-Oximeter. This is considered a highly accurate, objective gold standard for measuring oxygen saturation.
-
Sample Size for the Training Set:
- Not applicable. This device is a sensor for a pulse oximeter, and the performance testing described is for its accuracy in measurement, not for a trainable algorithm.
-
How Ground Truth for the Training Set was Established:
- Not applicable, as there is no mention of a training set for an algorithm in this context. The device's function is purely measurement-based, not based on machine learning.
§ 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).