(26 days)
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nomitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) 10 multiparameter devices for display on those devices.
The Masimo LNOP® Series of Sensors are indicated for the following:
- A single use oximetry sensor intended for adults and pediatrics greater than 30 kg
- A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
- A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg
- A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg
- A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
- A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
The Masino PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShareTM.
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.
The submitter, Masimo Corporation, provided information on the performance validation of their Masimo SET® Radical Pulse Oximeter with SatShare™.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Patient Type | Condition | Acceptance Criteria (Specified Accuracy) | Reported Device Performance (Clinical Study Results) |
|---|---|---|---|---|
| Saturation (% SpO2) | Adults, Pediatrics | No Motion | 70% - 100% ± 2 digits | ± 2 digits (against CO-Oximeter) |
| Saturation (% SpO2) | Adults, Pediatrics | Motion | 70% - 100% ± 3 digits | ± 3 digits (against CO-Oximeter) |
| Saturation (% SpO2) | Neonates | No Motion & Motion | 70% - 100% ± 3 digits | ± 3 digits (against CO-Oximeter: specifications down to 83% combined with adult clinical studies) |
| Saturation (% SpO2) | All | Low Perfusion | > 0.02% Pulse Amplitude and % Transmission > 5% | Meets performance requirements (against CO-Oximeter) |
| Pulse Rate (bpm) | Adults, Pediatric, Neonates | No Motion | 25 to 240 ± 3 digits | ± 3 digits (against ECG) |
| Pulse Rate (bpm) | Adults, Pediatric, Neonates | Motion | 25 to 240 ± 5 digits | ± 5 digits (against ECG) |
Note: The accuracy specifications (e.g., ± 2 digits) generally represent one standard deviation, encompassing 68% of the population, as stated in the document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (number of subjects) for each clinical study (test set). However, it does specify:
- Adults, Pediatrics: "human blood studies on healthy adult volunteers"
- Neonates: "human blood studies on neonates"
- Data Provenance: The studies were conducted on "healthy adult volunteers" and "neonates" in induced hypoxia states and under various motion and low perfusion conditions. The studies appear to be prospective as they involved inducing specific conditions (hypoxia, motion) to assess device performance. The country of origin is not explicitly stated but is implicitly within the scope of FDA regulations, suggesting the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not specify the number or qualifications of experts involved in establishing the ground truth. It relies on objective measurement devices for ground truth:
- For SpO2: A laboratory co-oximeter was used for arterial blood samples.
- For Pulse Rate: An ECG monitor was used.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by objective laboratory co-oximeters and ECG monitors, not through expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This device is a pulse oximeter, which provides direct physiological measurements, not interpretations that would typically involve human "readers" or AI assistance in that context. The "AI" (Masimo SET technology) is integral to the device's function, not an add-on for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies conducted demonstrate the standalone performance of the Masimo SET® Radical Pulse Oximeter with SatShare™. The device directly measures and displays SpO2 and pulse rate; the performance metrics are accuracy against established gold standards (co-oximeter and ECG), not human interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was:
- Laboratory Co-Oximeter: For functional oxygen saturation of arterial hemoglobin (SpO2), determined from arterial blood samples. This is an objective, laboratory-based gold standard.
- ECG Monitor: For pulse rate. This is an objective, clinical gold standard.
8. The Sample Size for the Training Set
The document does not explicitly state a separate "training set" sample size. The "values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." This implies that data from human studies was used to develop and refine the device's algorithms and look-up tables (effectively the training data for the device's inherent "algorithm"). The size of these studies is not quantified.
9. How the Ground Truth for the Training Set Was Established
The ground truth for what would be considered the "training set" (the data used to establish the device's empirically derived equations and look-up tables) was established by:
- Human blood studies on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions.
- Measurements taken against a laboratory co-oximeter. This indicates that the device's internal algorithms were developed and calibrated by comparing its readings to highly accurate co-oximetry measurements from real human blood samples under various challenging conditions.
§ 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).