(121 days)
The Masino Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (neasured by an SpO2 sensor) and carboxyhemoglobin saturation (measured by an Sp CO sensor) for adult, pediatric, and neonatal patients in hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and carboxyhemoglobin saturation (measured by an SpCO sensor). The Masimo Rainbow SET® Rad 57 and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Rad-57 Handheld Pulse CO-Oximeter with Rainbow technology is a noninvasive, arterial oxygen saturation, pulse rate, and carboxyhemoglobin monitor. The Rad-57 features a multicolored LED display that continuously displays numeric values for SpO2 and pulse rate, a Low Signal IQ Indicator (Low SIQ) indicator bars for Perfusion Index (PI) and Carboxyhemoglobin saturation (%SpCO). The Masimo SET Rad 57 Signal Extraction Pulse CO-Oximeter is intended to be used with Masimo's LNOP. LNOP. LNOPv, and LNCS series of oximetery sensors and patient cables and Masimo's Rainbow oximetery/HbCO sensors and Rainbow cables.
The provided document outlines the acceptance criteria and the studies performed to demonstrate the performance and substantial equivalence of the Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Target Performance) | Reported Device Performance (Achieved) |
|---|---|---|
| Oxygen Saturation (% SpO2) | ||
| No Motion Conditions | Adults, Pediatrics: 70-100% (± 2 digits) | Adults, Pediatrics: 70-100% (± 2 digits) in human blood studies on healthy adult volunteers in induced hypoxia against a laboratory CO-oximeter and ECG monitor. (This variation equals plus or minus one standard deviation which encompasses 68% of the population.) |
| Neonates: 70-100% (± 3 digits) | Neonates: 70-100% (± 3 digits) - validated for neonatal motion, and 1% added to saturation accuracy for fetal hemoglobin. (This variation equals plus or minus one standard deviation which encompasses 68% of the population.) | |
| Motion Conditions | Adults, Pediatrics: 70-100% (± 3 digits) | Adults, Pediatrics: 70-100% (± 3 digits) in human blood studies on healthy adult volunteers in induced hypoxia while performing rubbing and tapping motions. (This variation equals plus or minus one standard deviation which encompasses 68% of the population.) |
| Neonates: 70-100% (± 3 digits) | Neonates: 70-100% (± 3 digits) - validated for neonatal motion, and 1% added to saturation accuracy for fetal hemoglobin. (This variation equals plus or minus one standard deviation which encompasses 68% of the population.) | |
| Carboxyhemoglobin Saturation (% SpCO) | 0% - 40% (± 3 digits) | 0% - 40% (± 3 digits) in human blood studies on healthy adult volunteers against a laboratory CO-oximeter. (This variation equals plus or minus one standard deviation which encompasses 68% of the population.) |
| Pulse Rate (bpm) | ||
| No Motion Conditions | 25-240 (± 3 digits) | 25-240 (± 3 digits) in human blood studies on healthy adult volunteers in induced hypoxia. |
| Motion Conditions | 25-240 (± 5 digits) | 25-240 (± 5 digits) in human blood studies on healthy adult volunteers in induced hypoxia while performing rubbing and tapping motions. |
| Low Perfusion Performance | SpO2: ± 2 digits; Pulse Rate: ± 3 digits | SpO2: ± 2 digits; Pulse Rate: ± 3 digits (bench top testing against a Biotek 5 Index 2 simulator and Masimo's simulator with signal strengths > 0.02% and % transmission > 5% for saturations 70-100%.) (This variation equals plus or minus one standard deviation which encompasses 68% of the population.) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- SpO2 (No Motion, Motion): The studies were conducted on "healthy adult volunteers" for both no motion and motion conditions. The exact number of subjects is not explicitly stated in the provided text. The data provenance is "human blood studies" conducted locally (implied, as no other country is mentioned). The studies were prospective, as subjects were subjected to "progressive induced hypoxia."
- Carboxyhemoglobin Saturation (SpCO): The study for SpCO was conducted on "healthy adult volunteers." The exact number of subjects is not explicitly stated. The data provenance is "human blood" studies, implied to be local and prospective.
- Neonatal SpO2 (Motion): "Healthy adult volunteers" were used, with an adjustment for fetal hemoglobin. The exact number of subjects is not explicitly stated. The data provenance is "human blood studies," implied to be local and prospective.
- Low Perfusion Performance: This was tested using "bench top testing" with simulators, not human subjects for the performance accuracy validation itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The ground truth for the clinical studies (SpO2, SpCO, Pulse Rate) was established by a "laboratory CO-oximeter and ECG monitor" using arterial blood samples. There is no mention of human experts establishing ground truth for the test set in the conventional sense of adjudicated medical images or reports. The reference method (laboratory CO-oximeter) essentially served as the expert/gold standard.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth was established by direct physical measurements using a laboratory CO-oximeter and ECG monitor against arterial blood samples, not by expert consensus or a review process requiring 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, an MRMC comparative effectiveness study was not performed. This device is a measurement device (pulse CO-oximeter), not an AI-assisted diagnostic imaging tool that would typically involve human readers. The clinical studies focused on the device's accuracy in measuring physiological parameters against a reference standard.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the core of the evaluation was a standalone performance assessment of the device. The clinical studies directly compared the device's measurements (algorithm output) to the ground truth from a laboratory CO-oximeter and ECG monitor. The device's accuracy specifications (e.g., ± 2 digits) are presented as the standalone performance of the algorithm/device.
7. The Type of Ground Truth Used:
The ground truth used for the clinical studies was objective physiological measurement from:
- Arterial blood samples analyzed by a laboratory CO-oximeter (for SpO2 and SpCO).
- An ECG monitor (for pulse rate).
8. The Sample Size for the Training Set:
The document does not explicitly state the sample size for a training set. The device utilizes "Masimo SET technology" and a "multi-wavelength calibration equation" for SpCO. These imply that calibration and development (training) would have occurred. However, the provided text focuses on the validation studies performed to demonstrate performance for regulatory submission, not the specifics of internal model development or training data. The validation studies themselves serve as a test set.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide details on how the ground truth was established for any internal training or calibration sets used during the device's development. It only describes the ground truth for the clinical validation studies performed to demonstrate adherence to acceptance criteria. Given the nature of the device (measuring physiological parameters), it is highly probable that similar methods (laboratory CO-oximeter, controlled environments, induced hypoxia) would have been used for establishing ground truth during initial algorithm development and calibration.
§ 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).