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The Masimo SET" Rad-57 cm and m Pulse CO-Oximeters and accessories are indivated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO), pulse rate (measured by an SpOn sensor), carboxyhemoglobin, and/or methemoglobin saturation (measured by an SpCO/SpMet sensor) for adult, pediative, and neonaal patients in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET® Rad-57 cm and m Pulse CO-Oximeters and accessories are indicated for the continuous noninvasive montoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO-sensor) and carboxyhenoglobin and methemoglobin saturation or methemoglobin (measured by an SpCO/SoMet sepsor). The Masimo SFFT Rad-57 cm and m Pulse CO-Oximeters and accessories are indicated for use with adult, pediatric, and neouatal 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.

The Rad-57 cm and m Handheld Pulse CO-Oximetesr with Rainbow technology are noninvasive, arterial oxygen saturation and pulse rate monitor that also measure Carboxyhemoglobin. The Rad-ST featurena multicologies and Indicelosmallion display that continuously displays numeric values for SpO2 and pulse rate, a Low Signal (Q Indicator (Low SIQ) included LED) indicator bars for Perfusion Index (PI) and Carboxyhemoglobin saturation (%SpCO) and/or Methemoglobin saturation(%21). alarm status, alarm silence, battery life and SpCO/SpMet sensor connected. The Masino SET Rad-57 cm and and Photo (10-Oximeters are intended to be used with Masimo's LNOP and LNCS series of oximelery sensors and patient ables and Masimo is Rainbow SpCO/SpMet sensors and Rainbow cables.

Here's the breakdown of the acceptance criteria and the study details for the Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeters, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

• SpO2 (No Motion & Motion): Healthy adult volunteers. The number of subjects is not explicitly stated, but the studies were "human blood studies."
• Neonatal SpO2 (Motion): Healthy adult volunteers. The number of subjects is not explicitly stated.
• SpCO & SpMet: Healthy adult volunteers. The number of subjects is not explicitly stated.
• Low Perfusion: Benchtop testing using a Biotek Index 2 simulator and Masimo's simulator. Not applicable for human subjects.
• Data Provenance: The studies were conducted on "human blood" studies, implying prospective data collection in a controlled environment (induced hypoxia). The country of origin is not specified but is implicitly in the context of FDA submission, likely the US.

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

• SpO2, SpCO, SpMet: The ground truth was established using a laboratory CO-oximeter and, for SpO2 studies, an ECG monitor. No human experts were involved in establishing the primary ground truth for these physiological measurements. The reference standard itself (the laboratory CO-oximeter) is the "expert" here.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth was derived from objective laboratory instruments (CO-oximeter and ECG monitor), not from human expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This study focused on the standalone performance of the device against objective reference standards, not on the improvement of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone performance study was done. The described clinical and bench tests evaluate the device's accuracy in measuring SpO2, SpCO, SpMet, and pulse rate against reference standards, without human interpretation influencing the primary measurements.

7. The Type of Ground Truth Used:

• Instrumental Ground Truth / Reference Standard:
  • For SpO2, SpCO, and SpMet: A laboratory CO-oximeter was used to determine arterial blood gas values.
  • For SpO2 and Pulse Rate: An ECG monitor was also used in the SpO2 studies.
  • For Low Perfusion: Benchtop simulators (Biotek Index 2 and Masimo's simulator) were used.

8. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for a training set. The described studies are for validation/testing, not for training the algorithm. The device "Masimo SET Technology" is mentioned as having "validated for no motion accuracy" and "validated for motion accuracy," implying prior development and internal validation. The current document focuses on the performance of the Rainbow SET® Rad-57 cm and m Pulse CO-Oximeters.

9. How the Ground Truth for the Training Set was Established:

• The document does not provide details on how the ground truth for an internal training set (if one existed) was established. The information focuses on the validation studies against a laboratory CO-oximeter and ECG monitor for the listed performance criteria.

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