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Indications For Use:

Masimo Rad-67™ Pulse CO-Oximeter

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical settings.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

rainbow DCI-mini sensor

The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

The Masimo Rad-67™ Pulse CO-Oximeter is a handheld device that includes the Masimo Rainbow SET measurements.

The Rad-67™ has the same measurement technology and intended use as the cleared predicate, Pronto (K091057). The Rad-67™ includes Masimo Rainbow SET measurement technology, which enables the Rad-67™ to provide noninvasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi) and total hemoglobin concentration (SpHb®). The Rad-67™ can communicate through a wired or wireless connection to transfer data to external applications and devices.

The rainbow DCI-mini sensor, compatible accessory to the Rad-67™, is a reusable sensor that is compatible with Masimo rainbow SET technology and is intended for spot-check monitoring of functional oxygen saturation (SpO2), pulse rate (PR) and total hemoglobin (SpHb®).

Here's a breakdown of the acceptance criteria and the study details for the Masimo Rad-67™ Pulse CO-Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• SpHb Clinical Validation Study: 317 adult subjects.
• SpO2 No Motion Clinical Validation Study: "healthy, adult volunteers" (specific number not provided, but implies a cohort used for inducing desaturation).
• SpO2 Motion Clinical Validation Study: "healthy, adult volunteers" (specific number not provided).
• Data Provenance: The document does not specify the country of origin. It indicates these were prospective clinical studies performed by Masimo on Rad-67™ and rainbow DCI-mini sensors.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The ground truth for SpHb was established by a "HiCN reference method." For SpO2, the comparison is directly against actual arterial oxygen saturation levels achieved by inducing desaturation in volunteers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The studies focus on the device's standalone accuracy against physiological measurements, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance studies. They evaluate the accuracy of the Rad-67™ Pulse CO-Oximeter (which incorporates Masimo's Rainbow SET technology) in measuring SpO2 and SpHb directly against reference methods, without human-in-the-loop interpretation or assistance.

7. Type of Ground Truth Used

• SpHb: "HiCN reference method" (Hemiglobincyanide method, a laboratory gold standard for total hemoglobin concentration).
• SpO2: The context implies that the ground truth for SpO2 was derived from actual arterial blood oxygen saturation measured during controlled desaturation episodes in volunteers. This is typical for oximetry validation studies, often referred to as arterial blood gas (ABG) analysis or similar lab-based measurements.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size. This is common for medical devices where the underlying algorithm is typically developed by the manufacturer, and the regulatory submission focuses on the validation (test set) performance.

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

As no training set information is provided, there is no information on how ground truth for a training set would have been established.

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