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The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive 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 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 Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate to multiparameter devices for the display of those devices.

The Radical 7 Pulse CO-Oximeter and accessories (Radical 7) include the Masimo Rainbow SET technology. The Radical 7 Pulse CO-Oximeter provides nonitoring of arterial oxygen saturation (SpO3), 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 7 Pulse CO-Oximeter 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 (R), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7 Pulse CO-Oximeter also has a touchscreen and output interfaces, which include: SatShare connection to multi-parameter monitors, Nurse Call analog output, and RS-232 serial output, and wireless radio.

Here's a breakdown of the acceptance criteria and the study information for the Masimo Radical 7 Pulse CO-Oximeter and Accessories, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7 specifications." This implies that the reported device performance met or exceeded the "Acceptance Criteria" values listed in the specification table.

2. Sample Size Used for the Test Set and Data Provenance

• SpO2, SpCO, SpMet (Adult/Pediatric/Infant): Healthy adult volunteers. The exact number of volunteers is not specified, but the range of SpO2 (60-100%), SpCO (0-40%), and SpMet (0-15%) was tested.
• SpHb (Adult/Pediatric): Healthy adult volunteers and surgical patients with light to dark skin pigmentation. The exact number of patients is not specified, but the range of SpHb (8-17 g/dl) was tested.
• SpO2 and SpMet (Neonatal): 16 neonatal NICU patients.
  • Age range: 7-135 days old
  • Weight range: 0.5-4.25 kg
  • Number of data samples: 79 samples collected over a range of 70-100% SaO2 and 0.5-2.5% MetHb.
• RRa: Adults. The exact number of subjects is not specified.

Data Provenance: The studies appear to be prospective clinical studies conducted with human subjects. The country of origin for the data is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (pulse CO-Oximeter) uses a laboratory CO-Oximeter as the ground truth reference, not human experts. Therefore, information regarding "number of experts" and "qualifications of those experts" is not applicable in this context.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is established by a laboratory CO-Oximeter, which provides objective measurements, removing the need for human adjudication of results.

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 done. This device is a measurement device and its performance is evaluated against a golden standard reference (laboratory CO-Oximeter), not against human interpretation or a human-AI collaborative workflow.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations. The device's measurements (SpO2, PR, SpCO, SpMet, SpHb, RRa) are directly compared against the ground truth established by a laboratory CO-Oximeter or other appropriate reference standards, without human interpretation in the loop impacting the accuracy determination.

7. The Type of Ground Truth Used

The primary ground truth used is measurements from a laboratory CO-Oximeter.

• For SpO2, SpCO, SpMet, and SpHb, the device was tested "against a laboratory CO-Oximeter."
• For RRa, the specific ground truth method is not detailed beyond "based on vibratory signals from respiratory sounds," but it would involve a highly accurate reference for respiratory rate.

8. The Sample Size for the Training Set

The document does not provide details on a separate "training set" or its sample size. The description focuses on clinical studies performed for performance validation, which typically serve as the test set for regulatory submission. It's possible that internal development and calibration involved various datasets, but these are not explicitly detailed as a separate "training set" in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

As no explicit "training set" details are provided in this summary, the method for establishing its ground truth is also not mentioned. However, it can be inferred that any internal development or calibration data would likely have been established using similar reference standards (e.g., laboratory CO-Oximeters) as used for the validation studies.

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