(87 days)
The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo SET® Radical 7 Pulse CO-Oximeter 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. In addition, the Masimo SET® Radical 7 Pulse CO-Oximeter and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter (Radical 7) with Rainbow technology is noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), and/or methemoglobin saturation (%SpMet). The Radical 7 features an LCD display that continuously displays numeric values for %SpO2 and pulse rate. Other information displayed by the Radical 7 include: %SpCO and/or %SpMet. Low Signal IQ (Low SIQ), Perfusion Index (PI), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7 has output interfaces include: SatShare connection to multi-parameter monitors, Nurse Call analog output, and RS-232 serial output.
The Radical 7 is intended to be used with Masimo LNOP series of oximetery sensors, LNCS series of oximetery sensors, and patient cables. The Radical 7 is also intended to be used with Masimo Rainbow (SpCO/SpMet) sensors and Rainbow patient cables.
Here's an analysis of the acceptance criteria and the studies that support the Masimo Rainbow SET® Radical 7 CO-Oximeter, based on the provided text:
Acceptance Criteria and Device Performance for Masimo Rainbow SET® Radical 7 CO-Oximeter
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Oxygen Saturation (% SpO2) - No Motion | ||
| Adults, Pediatrics (70%-100%) | ± 2 digits | 70%-100% ± 2 digits |
| Neonates (70%-100%) | ± 3 digits | 70%-100% ± 3 digits |
| Oxygen Saturation (% SpO2) - Motion | ||
| Adults, Pediatrics (70%-100%) | ± 3 digits | 70%-100% ± 3 digits |
| Neonates (70%-100%) | ± 3 digits | 70%-100% ± 3 digits |
| Oxygen Saturation (% SpO2) - Low Perfusion | ||
| Adults, Pediatrics (70%-100%) | ± 2 digits | 70%-100% ± 2 digits |
| Neonates (70%-100%) | ± 3 digits | 70%-100% ± 3 digits |
| Carboxyhemoglobin Saturation (% SpCO) | ± 3 digits (for 1%-40%) | 1%-40% ± 3 digits |
| Methemoglobin Saturation (% SpMet) | ± 1 digit (for 1%-15%) | 1%-15% ± 1 digits |
| Pulse Rate (bpm) - No Motion | ± 3 digits (for 25-240 bpm) | 25 to 240 ± 3 digits |
| Pulse Rate (bpm) - Motion | ± 5 digits (for 25-240 bpm) | 25 to 240 ± 5 digits |
| Pulse Rate (bpm) - Low Perfusion | ± 3 digits (for 25-240 bpm) | 25 to 240 ± 3 digits |
| Non-clinical (Bench) Test (SpO2) | Same accuracy as simulator (± 2 digits) | Returned the same oxygen saturation accuracy values within ± 2 digits |
| Non-clinical (Bench) Test (Pulse Rate) | Same accuracy as simulator (± 3 digits) | Returned the same pulse rate values within ± 3 digits |
Note: The "Acceptance Criteria" column is derived directly from the "Accuracy" section of the specifications, as the document states that the studies "validated" or "demonstrate" that the device meets these specified accuracies.
2. Sample Size Used for the Test Set and Data Provenance
- SpO2 (No Motion, Motion, Neonates): The studies were conducted on "healthy adult volunteers" for non-neonatal cases and "human blood studies" for neonates (with a 1% added to account for fetal hemoglobin effects). The exact number of volunteers/patients or data points is not specified in the provided text.
- SpO2 (Low Perfusion): Benchtop testing was used with a Biotek Index 2 simulator and a Masimo simulator. No human sample size is applicable for this specific test.
- SpCO & SpMet: Validated in "human blood on healthy adult volunteers." The number of volunteers is not specified.
- Data Provenance: The studies are described as "human blood studies on healthy adult volunteers" and "induced hypoxia studies." This suggests the data is prospective and likely collected for the purpose of this device validation. The country of origin is not explicitly stated, but given the FDA submission, it's presumed to be within the regulatory framework of the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for all measurements (SpO2, SpCO, SpMet, Pulse Rate) was established using:
- Laboratory CO-oximeter: This instrument served as the gold standard for comparing arterial blood samples.
- ECG monitor: Used for pulse rate ground truth during some SpO2 studies.
The text does not specify the number of human experts used to establish the ground truth or their qualifications. The ground truth relied on accredited laboratory equipment rather than expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
No information on adjudication method (e.g., 2+1, 3+1, none) is provided. The studies compared the device's readings directly against a laboratory CO-oximeter and ECG monitor, implying a direct comparison without a need for expert adjudication of conflicting readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The studies focused on the device's accuracy against a gold standard (laboratory CO-oximeter and ECG monitor), not on how human readers' performance might improve with or without AI assistance from the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, standalone performance was evaluated. All the listed accuracy studies (for SpO2, SpCO, SpMet, and Pulse Rate under various conditions) represent the standalone performance of the device itself (the algorithm and sensor system) compared to the physiological ground truth. There is no mention of human-in-the-loop performance evaluation in the provided text.
7. Type of Ground Truth Used
- SpO2, SpCO, SpMet: Established by measuring arterial blood samples with a laboratory CO-oximeter.
- Pulse Rate: Established using an ECG monitor.
8. Sample Size for the Training Set
The document describes validation studies, but does not provide any information regarding a training set or its sample size. This suggests that if machine learning was used, the training data details were not included in this submission summary. The context implies a more traditional signal processing and calibration approach rather than a deep learning model requiring a distinct training and test set with explicit disclosure.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, no information is provided on how its ground truth would have been established.
§ 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).