(27 days)
The additional Masimo series of sensors are intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The following additional Masimo Sensors are indicated for the continuous noninvasive function of arterial hemoglobin (SpO2) and pulse rate:
Single use oximetry sensor intended for adults and pediatrics greater than 10 kg
Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg
Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg
The Masimo 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.
Here's a summary of the acceptance criteria and study information for the Masimo series of oximetry sensors, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported accuracy (Arms) for different sensors and patient populations. The document states a target range of 70% to 100% SaO2 for these accuracy figures.
| Device/Sensor Type | Patient Population | Acceptance Criteria (Accuracy Arms) | Reported Device Performance (Accuracy Arms) over 70%-100% SaO2 Range |
|---|---|---|---|
| NR7 Sensor | Adults | Not explicitly stated (implied) | ± 2% |
| LNOP-Ear Sensor | Adults | Not explicitly stated (implied) | ± 3.5% |
| LNOP-YI Sensor | Adults & Pediatrics | Not explicitly stated (implied) | ± 2% for adults and pediatrics |
| LNOP-YI Sensor | Neonates | Not explicitly stated (implied) | ± 3% for neonates |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated beyond "adult volunteers."
- Data Provenance: The study was conducted on "adult volunteers." No specific country of origin is mentioned, but the company is based in Irvine, CA, USA, suggesting the study was likely conducted in the US. The study appears to be prospective, as it involved performance testing on volunteers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth was established through direct measurement (arterial blood samples), not expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established through direct measurement (arterial blood samples).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. This device measures physiological parameters.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Yes, a standalone performance study was done. The "Performance Data and Conclusions" section describes the device's accuracy by comparing its readings to arterial blood samples, which is a standalone evaluation of the device itself.
7. Type of Ground Truth Used
The ground truth used was arterial blood sampled. This refers to direct measurement of oxygen saturation from arterial blood.
8. Sample Size for the Training Set
Not applicable. The document describes a performance validation study, not the development or training of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no mention of a training set for a machine learning algorithm.
§ 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).