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The Rad-C Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp).

The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G is a handheld pulse oximeter that provides Masimo SET pulse oximetry and Respiration Rate from the Plethysmograph. The Rad-G is provided with an internal battery and a connection to an external power supply to support continuous monitoring. The technologies supported in the Rad-G are the same as what has been cleared with the Radical-7.

The Masimo Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The device's performance specifications are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly detail the sample size for a specific clinical test set for the Masimo Rad-G. Instead, it states that "additional clinical testing was not deemed necessary to support the substantial equivalence" because the subject device "utilizes the same monitoring technologies as the predicate (K193242)," the Masimo Radical-7 Pulse Co-Oximeter and Accessories. The performance specifications listed are identical to those of the predicate device.

Therefore, the performance data for the Masimo Rad-G device is based on the data provenance of the predicate device, K193242, which is not detailed in this document.

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

Since "additional clinical testing was not deemed necessary" for the subject device due to its technological similarity to the predicate, this information is not provided for the Masimo Rad-G directly in this document. The ground truth would have been established during the development and clearance process of the predicate device (K193242), but details are not available here.

4. Adjudication Method for the Test Set

As "additional clinical testing was not deemed necessary" for the subject device, details on adjudication methods for a specific test set are not present in this document. This would have been part of the predicate device's (K193242) clinical validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned in the provided text for the Masimo Rad-G. The document focuses on demonstrating substantial equivalence to a predicate device rather than comparing against human readers or assessing improvement with AI assistance.

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

The performance specifications listed are for the device's direct measurements (SpO2, PR, RRp). These are standalone algorithms that continuously process physiological signals to output numerical values. The device itself is an automated measurement tool, thus its listed performance is inherently standalone (algorithm-only). The context implies that these are measurements derived directly from the device's sensor and internal processing, rather than requiring human interpretation for the primary output.

7. The Type of Ground Truth Used

Based on the nature of pulse oximetry and respiration rate measurements, the ground truth for establishing the accuracy of the predicate device (and by extension, the Masimo Rad-G) would typically involve:

• Fractional Arterial Oxygen Saturation (SaO2) from a co-oximeter and manual pulse rate counts for SpO2 and PR accuracy studies, often obtained from subjects undergoing induced hypoxia in controlled clinical settings.
• Reference respiration rate measurements (e.g., from capnography, impedance pneumography, or direct observation) for RRp accuracy studies.

The document states that the Masimo Rad-G utilizes the same principles of operation and has the same performance specifications as the predicate device (Masimo Radical-7, K193242). This indicates that the ground truth for the Masimo Rad-G's performance is derived from the ground truth established for the predicate device.

8. The Sample Size for the Training Set

The document does not describe the a "training set" in the context of machine learning, nor does it specify a sample size for such a set. The device utilizes established physiological measurement technologies (Masimo SET pulse oximetry and Respiration Rate from Plethysmograph) rather than a novel machine learning algorithm that would require a dedicated training set. The performance is validated against clinical trials previously conducted for the predicate technology.

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

Since there is no mention of a "training set" in the machine learning sense, this information is not applicable. The core technology and its accuracy were established during the development and clinical validation of the Masimo SET Pulse Oximetry and Respiration Rate from Plethysmograph system, which underlies both the predicate and subject devices. This would have involved comparing the device's measurements against accepted clinical reference standards (as described in point 7).

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