(27 days)
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is 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.
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, pediatric, and neonatal. patients during both no motion conditions, for patients who are well or poorly perfused in hospitals, 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) to multiparameter devices for display on those devices.
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 Masimo SET® Radical Pulse Oximeter with SatShare™ is a pulse oximeter intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, and neonatal patients across various healthcare settings.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (from Specifications) | Reported Device Performance (from Clinical Studies) |
|---|---|---|
| Saturation (% SpO2) - No Motion Conditions (70%-100%) | Adults, Pediatrics: ± 2 digits | |
| Neonates: ± 3 digits | The clinical studies show: |
- Adults and Pediatrics: within ± 2 digits
- Neonates: within ± 3 digits |
| Saturation (% SpO2) - Motion Conditions (70%-100%) | Adults, Pediatrics: ± 3 digits
Neonates: ± 3 digits | The clinical studies show: - Adults and Pediatrics: within ± 3 digits
- Neonates: within ± 3 digits |
| Pulse Rate (bpm) - No Motion Conditions (25-240) | Adults, Pediatric, Neonates: ± 3 digits | The clinical studies show: - Adults, Pediatric, Neonates: within ± 3 digits |
| Pulse Rate (bpm) - Motion Conditions (25-240) | Adults, Pediatric, Neonates: ± 5 digits | The clinical studies show: - Adults, Pediatric, Neonates: within ± 5 digits |
| Low Perfusion Performance (SpO2) | ± 2 digits (> 0.02% Pulse Amplitude, % Transmission > 5%) | The clinical studies on healthy adult volunteers show performance within ± 2 digits. (Note: Neonate low perfusion clinical studies were also performed, and the results claim the device meets performance). |
| Low Perfusion Performance (Pulse Rate) | ± 3 digits (> 0.02% Pulse Amplitude, % Transmission > 5%) | The clinical studies on healthy adult volunteers show performance within ± 3 digits. (Note: Neonate low perfusion clinical studies were also performed, and the results claim the device meets performance). |
2. Sample Size Used for the Test Set and the Data Provenance:
The document mentions "human blood studies on healthy adult volunteers" and "clinical studies...on neonates." However, specific sample sizes (number of subjects/cases) for the test sets are not explicitly stated in the provided text for any of the clinical or bench tests.
Data Provenance:
- Clinical Studies: Healthy adult volunteers and neonates.
- Country of Origin: Not explicitly stated, but the studies followed US FDA regulations (21 CFR Part 812, Part 50, Part 56), implying they were conducted in the US or under US regulatory oversight.
- Retrospective or Prospective: The wording "clinical studies were performed" and "subjects during no motion and motions who were subjected to a progressive induced hypoxia" indicates these were prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The ground truth for SpO2 was established by a laboratory co-oximeter and for pulse rate by an ECG monitor, not by expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. The ground truth was established by objective medical devices (co-oximeter and ECG monitor), not through expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic imaging tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the overall study, particularly the clinical trials, can be considered a standalone performance evaluation. The device (algorithm + hardware) directly measures SpO2 and pulse rate, and its performance is compared directly against reference devices (co-oximeter and ECG), not with human interpretation as an intermediate step. The document explicitly states the "Masimo SET® Radical Pulse Oximeter with SatShare™...returned the same saturation accuracy values...and pulse rate values" when compared to simulators in bench testing and against co-oximeters/ECG in clinical studies.
7. The Type of Ground Truth Used:
The ground truth for the clinical studies was established using objective medical reference devices:
- For oxygen saturation (SpO2): Laboratory CO-Oximeter analysis of arterial blood samples.
- For pulse rate: ECG Monitor.
8. The Sample Size for the Training Set:
The document mentions that 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 refers to the development/calibration of the device's a-priori look-up tables. However, like the test set, the specific sample size for this internal "training" or calibration set is not explicitly stated in the provided text.
9. How the Ground Truth for the Training Set Was Established:
The ground truth for the training/calibration set (which informed the device's look-up tables) was established by:
- Human blood studies on healthy adult volunteers.
- Induced hypoxia states (to achieve various saturation levels).
- Measurement of arterial hemoglobin oxygen using a laboratory co-oximeter.
- These studies were conducted during both motion and non-motion 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).