(143 days)
The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET® Radical 7R 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 7R Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories (Radical 7R) include the MX board with Masimo Rainbow SET technology. The Radical 7R provides noninvasive monitoring of arterial oxygen saturation (%SpO-), pulse rate (PR), carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa). Other information displayed by the Radical 7R includes: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (SpOC), Hematocrit (SpHct), Signal Identification Quality (SIQa), Respiration Indicator (RI), alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7R has output interfaces include: SatShare connection to multiparameter monitors, Nurse Call analog output, and RS-232 serial output.
Here's a breakdown of the acceptance criteria and study information for the Masimo Rainbow SET® Radical 7R CO-Oximeter, based on the provided text:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) |
|---|---|---|
| SpO2 (Adults/Pediatrics/Infants) | No Motion: 60-80 ± 3%; 70-100 ± 2% | The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications. |
| SpO2 (Neonates) | No Motion: 70-100 ± 3% | SpO2 accuracy on 16 neonatal NICU patients (7-135 days old, 0.5-4.25 kg) over a range of 70-100% SaO2: 2.9% SpO2 (against a laboratory CO-Oximeter) |
| SpO2 (Motion) | 70-100 ± 3% | The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications. |
| SpO2 (Low Perfusion) | 70-100 ± 2% | The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications. |
| PR (Adults/Pediatrics/Infants/Neonates) | No Motion: 25-240 ± 3 bpm | The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications. |
| PR (Motion) | 25-240 ± 5 bpm | The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications. |
| PR (Low Perfusion) | 25-240 ± 3 bpm | The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications. |
| SpCO (Adults/Pediatrics/Infants) | 1-40 ± 3% | Accuracies (rms) equal to or less than specifications. (against a laboratory CO-Oximeter) |
| SpMet (Adults/Pediatrics/Infants/Neonates) | 1-15 ± 1% | SpMet accuracy on 16 neonatal NICU patients (7-135 days old, 0.5-2.5% MetHb): 0.9% SpMet (against a laboratory CO-Oximeter) |
| SpHb (Adults/Pediatrics) | 8-17 ± 1 g/dl (arterial or venous) | Accuracies (rms) equal to or less than specifications. (against a laboratory CO-Oximeter) |
| RRa (Adults) | 4-70 ± 1 breath per minute | The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications. |
Study Information:
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Sample size used for the test set and the data provenance:
- SpO2, SpCO, SpMet (Adults): "healthy adult volunteers" (specific number not provided).
- SpO2, SpMet (Neonates): 16 neonatal NICU patients.
- SpHb (Adults/Pediatrics): "healthy adult volunteers and on surgical patients with light to dark skin pigmentation" (specific number not provided).
- Data Provenance: The text does not explicitly state the country of origin. It indicates "healthy adult volunteers," "surgical patients," and "neonatal NICU patients," implying prospective clinical studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device and study. The ground truth was established using a laboratory CO-Oximeter (a reference medical device), not human expert consensus.
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Adjudication method:
- Not applicable as the ground truth was derived from a laboratory CO-Oximeter.
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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 involving human readers and AI assistance was not mentioned. The studies described focus on the device's accuracy against a reference standard.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical studies describe the standalone performance of the device's algorithm against a laboratory CO-Oximeter for various physiological parameters (SpO2, SpCO, SpMet, SpHb).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference Medical Device: A laboratory CO-Oximeter was used as the ground truth for SpO2, SpCO, SpMet, and SpHb measurements. This is considered a gold standard for these physiological parameters.
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The sample size for the training set:
- The document does not explicitly state the sample size used for the training set. It describes the clinical studies used to validate performance, which would be considered the test set.
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How the ground truth for the training set was established:
- This information is not provided in the summary. Typically, training data for medical devices like this would be collected similarly to validation data, using reference instrumentation, but the specifics are not detailed here.
§ 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).