(28 days)
The Masimo SET® Rad-8 Pulse Oximeter is 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® Rad 8 pulse oximeter is indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo SET" Rad-8 Pulse Oximeter has the following features and benefits:
- Clinically proven Masimo SET technology performance
- Applicable for use on neonate, pediatric and adult patients .
- Proven for accurate monitoring in motion and low perfusion environments .
- SpO2, pulse rate, alarm, and perfusion index displays .
- Signal IQ™ for signal identification and quality indication
- Lightweight, convenient handheld design
- Audible alarm for sensor-off and low battery
- Alarms for Hi/Low saturation and Hi/Low pulse rate
- Trauma and FastSat™
- Three sensitivity levels Max, Normal and APODIN .
- Adjustable alarm volume
- Adjustable averaging 2 to 16 seconds
- Trend data storage and output .
- Two models: Horizontal or Vertical position
The Masimo SET Rad-8 Pulse Oximeter is designed for continuous non-invasive monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonatal patients, across various environments including hospitals and homes. The device measures SpO2 and pulse rate, and includes features such as alarm functions, signal quality indication, and adjustable sensitivity levels.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Set by Masimo SET Technology) | Reported Device Performance (Masimo SET Rad-8 Pulse Oximeter) |
|---|---|---|
| Saturation (% SpO2) - No Motion | Healthy adult volunteers, induced hypoxia studies, 70-100% SpO2 range, validated against laboratory co-oximeter and ECG monitor. Variation equals ± 1 standard deviation (encompasses 68% of the population). | Adults, Pediatrics: 70% - 100% ± 2 digits, 0% - 69% unspecified. Neonates: 70% - 100% ± 3 digits, 0% - 69% unspecified. Clinical studies show accuracy for adults and pediatrics "within and peblacter" (likely a typo, intended to mean a specific range or agreement) during no motion conditions when compared to ECG. |
| Saturation (% SpO2) - Motion | Healthy adult volunteers, induced hypoxia studies, 70-100% SpO2 range, validated against laboratory co-oximeter and ECG monitor, while performing rubbing and tapping motions (2-4 Hz, 1-2 cm amplitude) and non-repetitive motion (1-5 Hz, 2-3 cm amplitude). Variation equals ± 1 standard deviation (encompasses 68% of the population). For neonates, an additional 1% is added to adult accuracy specifications. | Adults, Pediatrics: 70% - 100% ± 3 digits, 0% - 69% unspecified. Neonates: 70% - 100% ± 3 digits, 0% - 69% unspecified. Clinical studies show saturation accuracy values for adults and pediatrics during motion conditions (with pulse rate accuracy of ± 5 digits) when compared to ECG. (The exact saturation range for motion conditions is not explicitly stated in the performance section but is implied by the clinical study description). |
| Pulse Rate (bpm) - No Motion | (Implicitly from the SpO2 no motion study, as it's measured by the SpO2 sensor) | Adults, Pediatric, Neonates: 25 to 240 ± 3 digits. Clinical studies show pulse rate accuracy values within ± 3 digits during no motion conditions when compared to ECG. |
| Pulse Rate (bpm) - Motion | (Implicitly from the SpO2 motion study, as it's measured by the SpO2 sensor) | Adults, Pediatric, Neonates: 25 to 240 ± 5 digits. Clinical studies show pulse rate accuracy values within ± 5 digits during motion conditions when compared to ECG. |
| Low Perfusion Performance (SpO2 & PR) | Bench top testing against Biotek Index 2 simulator and Masimo's simulator, with signal strengths > 0.02% pulse amplitude and > 5% transmission, for saturations 70-100%. Variation equals ± 1 standard deviation (encompasses 68% of the population). | Saturation (% SpO2): ± 2 digits. Pulse Rate: ± 3 digits. Clinical studies demonstrate that the Masimo SET® technology meets its performance requirements for low perfusion conditions. |
| Bench Testing (Simulator Comparison) | (Implicitly, to demonstrate equivalence with devices that cover the same range of saturation and pulse rates) | Comparison to simulators showed results within ± 3 digits of the simulator's readings. The device was subjected to bench testing using a simulator that covered the range of saturation and pulse rates specified by both the device and predicate devices. The results showed that the Masimo SET® Rad-8 Pulse Oximeter returned the same saturation and pulse rate values within ± 3 digits when compared to the simulators used. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for the clinical studies are not explicitly provided in the document.
The data provenance for the clinical studies is described as:
- Country of Origin: Not explicitly stated, but the studies mention "human blood studies on healthy adult volunteers" and compliance with US regulations (21CFR), suggesting the studies were conducted in the United States.
- Retrospective or Prospective: The clinical studies were conducted as "progressive induced hypoxia" and "low perfusion conditions" on healthy adult volunteers, indicating these were prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth. However, the ground truth was based on measurements from a laboratory co-oximeter and an ECG monitor. These are established medical devices used for precise physiological measurements, implying expert operation and calibration, but not expert human interpretation for ground truth generation.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was established by objective measurements from a co-oximeter and ECG monitor, not by expert human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes studies comparing the device's performance against objective physiological measurements (co-oximeter, ECG, simulators) and a predicate device, but not a MRMC study evaluating human reader improvement with or without AI assistance. This device is a pulse oximeter, which provides direct physiological measurements, not an imaging or diagnostic AI system that assists human readers.
6. Standalone Performance
Yes, a standalone performance study was done. The entire set of clinical and bench tests evaluates the device's performance independently in various conditions (no motion, motion, low perfusion) against established ground truth methods (laboratory co-oximeter, ECG monitor, simulators). The reported accuracy specifications (e.g., ± 2 digits for SpO2 in no motion) represent the standalone performance of the algorithm/device.
7. Type of Ground Truth Used
The ground truth used for the clinical studies was primarily:
- Laboratory Co-Oximeter: For arterial hemoglobin oxygen saturation (SpO2) measurements from arterial blood samples in induced hypoxia studies.
- ECG Monitor: For pulse rate measurements and potentially as a reference for cardiac activity during the hypoxia studies.
- Biotek Index 2 simulator and Masimo's simulator: For low perfusion accuracy and bench testing against specified ranges.
8. Sample Size for the Training Set
The document does not explicitly state the sample size for a separate "training set." The values in the look-up table within the device's software are based upon "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions." This implies that data from such studies was used to develop and "train" the algorithm, but a specific "training set sample size" as commonly defined for AI/ML validation is not provided. It's more likely that these refer to the pre-market development and calibration data.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the underlying algorithm (which resulted in the device's "look-up table") was established through:
- Human blood studies: On healthy adult volunteers.
- Induced hypoxia states: To achieve a range of oxygen saturation levels.
- Laboratory co-oximeter: Used to obtain the reference arterial hemoglobin oxygen saturation values from arterial blood samples.
- Motion and non-motion conditions: To account for different physiological scenarios.
This process involves direct, highly precise measurements of arterial blood oxygenation under controlled conditions to create the empirical data points used to calibrate the device's SpO2 calculation 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).