(102 days)
The Masimo Rainbow 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/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpHb sensor). The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous monitoring data obtained from the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation 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® Rad 87 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/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpHb sensor). The Masimo Rainbow SET® Rad 87 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 hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter 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) and total hemoglobin concentration (measured by an SpHb sensor). The Masimo Rainbow SET® Rad-57 t 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.
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories (Radical 7), the Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories (Rad 87), and the Masino Rainbow SET® Rad 57t Pulse CO-Oximeter and accessories (Rad 57t) have the noninvasive monitoring Masimo Rainbow SET technology.
The Radical 7 provides monitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Radical 7 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), 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 Rad 87 provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends. The Rad 87 has output interfaces include: Nurse Call analog output, and RS-232 serial output.
The Rad 57t provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends.
The Radical 7, Rad 87, and Rad 57t are intended to be used with Masimo LNOP series of oximetry sensors and patient cables, Masimo LNCS series of oximetry sensors and patient cables, Masimo Rainbow (SpCO/SpMet) sensors and patient cables, and Masimo Rainbow (SpCO/SpMet/SpHb) sensors and patient cables.
The provided text describes the specifications and some testing details for the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories, Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories, and Masimo Rainbow SET® Rad 57t Pulse CO-Oximeter and accessories.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The device performance is described in terms of "Accuracy" for various parameters. The acceptance criteria are implicitly those stated "Specifications" as the expected accuracy for each parameter.
| Feature | Type of Pulse CO-Oximeter | Acceptance Criteria (Specifications) | Reported Device Performance (Achieved Accuracy) |
|---|---|---|---|
| Accuracy - SpO2 | Radical 7, Rad 87, Rad 57t | Adults, Pediatrics, Infants: 60% - 80% ± 3% | |
| Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 2% | |||
| Adults, Pediatrics, Infants, Neonates: 0% - 69% unspecified | During No Motion Conditions: |
- Adults, Pediatrics, Neonates: 70-100% SpO2 with ±2% against a laboratory CO-Oximeter and ECG monitor. (Footnote 2)
- Neonatal NICU patients (7-135 days, 0.5-4.25 kg): 70-100% SaO2 with a resultant accuracy of 2.9% SpO2. (Footnote 1)
During Motion Conditions: - Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 3%.
- Human blood studies on healthy adult male and female volunteers in induced hypoxia studies while performing rubbing and tapping motions. (Footnote 3)
Low Perfusion: - Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 2%.
- Benchtop testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of >0.02% and transmission of >5% for saturations 70-100%. (Footnote 4) |
| Accuracy - Pulse Rate | Radical 7, Rad 87, Rad 57t| Adults, Pediatrics, Infants, Neonates: 25 - 240 ± 3 bpm (No Motion, Low Perfusion)
Adults, Pediatrics, Infants, Neonates: 25 - 240 ± 5 bpm (Motion Conditions) | During No Motion Conditions: 25 - 240 ± 3 bpm.
During Motion Conditions: 25 - 240 ± 5 bpm.
Low Perfusion: 25 - 240 ± 3 bpm. - Validated for range 25-240 bpm in benchtop testing against a Biotek Index 2 simulator. (Footnote 5) |
| Accuracy - SpCO | Radical 7, Rad 87 | Adults, Pediatrics, Infants: 1% - 40% ± 3% | During No Motion Conditions: - Adults, Pediatrics, Infants: 1% - 40% ± 3%.
- Determined by testing on healthy adult volunteers in the range of 0-40% SpCO against a laboratory CO-Oximeter. (Footnote 1) |
| Accuracy - SpMet | Radical 7, Rad 87 | Adults, Pediatrics, Infants, Neonates: 1% - 15% ± 1% | During No Motion Conditions: - Adults, Pediatrics, Infants, Neonates: 1% - 15% ± 1%.
- Determined by testing on healthy adult volunteers in the range of 0-15% SpMet against a laboratory CO-Oximeter. (Footnote 1)
- Neonatal NICU patients (7-135 days, 0.5-4.25 kg): 0.5-2.5% MetHb with a resultant accuracy of 0.9% SpMet. (Footnote 1) |
| Accuracy - SpHb | Radical 7, Rad 87, Rad 57t| Adults, Pediatrics: 7 - 17 g/dl ± 1 g/dl
(*SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 7 - 17 g/dl SpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.) | During No Motion Conditions: - Adults, Pediatrics: 7 - 17 g/dl ± 1 g/dl.
- Validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 7 - 17 g/dl SpHb against a laboratory CO-oximeter. (Specification Table, SpHb Accuracy)
- Note: SpHb accuracy not validated with motion or low perfusion. |
2. Sample Size Used for the Test Set and Data Provenance
- SpO2, SpCO, SpMet (Adults): "Healthy adult volunteers" for SpO2 (60-100%), SpCO (0-40%), and SpMet (0-15%). The exact number of volunteers is not specified, but it's stated that "This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population weight." (Footnote 2). The data provenance is described as "human blood studies" and "induced hypoxia studies," implying prospective data collection in a controlled setting (likely the US, given the submission location).
- SpO2, SpMet (Neonates): "16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg." "Seventy-nine (79) data samples were collected." This appears to be prospective clinical data. The country of origin is not specified but is likely in the US.
- SpO2 (Motion Conditions): "healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions." The specific number of volunteers is not provided. Data provenance is prospective human blood studies in a controlled environment.
- SpO2 (Low Perfusion): "Bench top testing against a Biotek Index 2 simulator and Masimo's simulator." This is simulated data, not human patient data.
- Pulse Rate: "Bench top testing against a Biotek Index 2 simulator." This is simulated data, not human patient data.
- SpHb (Adults/Pediatrics): "healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation." The specific number of volunteers/patients is not provided. Data provenance is described as human clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by a "laboratory CO-Oximeter" for SpO2, SpCO, SpMet, and SpHb, and an "ECG monitor" for SpO2 (in conjunction with the laboratory CO-Oximeter) and a "Biotek Index 2 simulator" for pulse rate and low perfusion SpO2.
No human experts were explicitly stated to establish the ground truth for the measurements; rather, validated reference instruments were used. Therefore, the concept of "number of experts" and "qualifications of experts" as typically applied to image annotation (e.g., radiologists) is not directly applicable here. The accuracy of the reference instruments serves as the ground truth.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by reference instruments (laboratory CO-Oximeter, ECG monitor, Biotek Index 2 simulator), not by human adjudication of observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The description focuses on the standalone performance of the device against reference standards, not on how human readers improve with or without AI assistance. This device is a measurement instrument, not an AI diagnostic tool that assists human readers.
6. Standalone (Algorithm-Only) Performance Study
Yes, this entire submission is primarily a standalone performance study. The reported accuracies (e.g., ±2%, ±3%, ±1 g/dl) are for the Masimo devices running their internal algorithms, comparing their output directly to established reference methods (laboratory CO-Oximeter, ECG, simulators). There is no human-in-the-loop component mentioned in these performance evaluations.
7. Type of Ground Truth Used
The type of ground truth used is reference standard measurements:
- Laboratory CO-Oximeter: For SpO2, SpCO, SpMet, and SpHb.
- ECG monitor: For SpO2 (used in conjunction with the CO-Oximeter).
- Biotek Index 2 simulator and Masimo's simulator: For SpO2 (low perfusion) and Pulse Rate.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. The device utilizes "multi-wavelength calibration equations" (Section 5, Page 3), which would have been developed using a dataset, but the size of this dataset is not specified. The studies described appear to be validation (test set) studies for the final calibrated device.
9. How the Ground Truth for the Training Set Was Established
As with point 8, the document does not detail how a "training set" ground truth was established. The device relies on "multi-wavelength calibration equations." It can be inferred that these equations were developed and calibrated using a similar methodology to the validation studies (i.e., comparing non-invasive readings to invasive or gold-standard laboratory CO-oximetry measurements across a range of physiological states and patient types). However, the specifics of this development process, including sample size or ground truth establishment for that specific phase, are not provided.
§ 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).