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The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET® Rad-8 Pulse Oximeter and Accessories (Rad 8) have the following features and benefits:

• Clinically proven Masimo SET technology performance .
• · Applicable for use on neonate, pediatric and adult patients
• Proven for accurate monitoring in motion and low perfusion environments .
• SpO2, pulse rate, alarm, and perfusion index displays .
• Signal IQ™ for signal identification and quality indication .
• · Lightweight, convenient handheld design
• · Audible alarm for sensor-off and low battery
• Alarms for Hi/Low saturation and pulse rate .
• Trauma and FastSat™ .
• Three sensitivity levels Max, Normal and APOD™ .
• · Adjustable alarm volume
• · Adjustable averaging 2 to 16 seconds
• · Trend data storage and output
• · Two models: Horizontal or Vertical position

The Rad 8 in this filing is substantially equivalent to the predicate device (K053269). The reason for this filing is to revise the upper limit of the pulse rate accuracy range.

Here's a summary of the acceptance criteria and study information for the Masimo SET® Rad-8 Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample sizes for all studies are not explicitly stated, however, the following can be inferred:

• No Motion Accuracy (Adults): "human blood studies on healthy adult volunteers" – specific number not given.
• No Motion Accuracy (Neonates, Infants, Pediatrics): "human blood studies... on neonates, infants and pediatric patients with congenital cyanotic cardiac lesions" – specific number not given.
• Motion Accuracy (Adults): "human blood studies on healthy adult volunteers" – specific number not given.
• Motion Accuracy (Neonates, Pediatrics): "human blood studies for adults... with added 1% to adult accuracy specifications." This implies the neonate/pediatric motion accuracy was extrapolated from adult studies with an adjustment, rather than entirely separate human studies for motion on neonates/pediatrics.
• Low Perfusion Accuracy: "bench top testing against a Biotek Index 2 simulator and Masimo's simulator" – This indicates a non-human, laboratory-based test.

Data Provenance: The human blood studies were conducted on "healthy adult volunteers" and "neonates, infants and pediatric patients with congenital cyanotic cardiac lesions." The document does not specify the country of origin of this data, but the company is based in Irvine, CA, USA, and the FDA submission is to the US FDA. The studies involved "induced hypoxia," indicating prospective human studies.

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

The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. For SpO2 and pulse rate accuracy, the ground truth was established using:

• Laboratory co-oximeter and ECG monitor: These are considered gold-standard clinical instruments for measuring blood oxygen saturation and heart rate, respectively. Their measurement methods effectively serve as the "ground truth."
• Biotek Index 2 simulator and Masimo's simulator: For low perfusion testing, these simulators provided controlled, known values for saturation and signal strength.

No human experts were explicitly mentioned as interpreting data to establish ground truth for these physiological measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from calibrated gold-standard instruments (co-oximeter, ECG monitor) or simulators, not through expert consensus or adjudication.

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

Not applicable. This device is a pulse oximeter for direct physiological measurement, not an AI-assisted diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

Yes, the studies described are inherently "standalone" in functionality. The device directly measures and reports SpO2 and pulse rate. The studies validated the device's ability to accurately perform these measurements against established gold standards (laboratory co-oximeter, ECG monitor, and simulators). There isn't a "human-in-the-loop" component in the fundamental accuracy evaluation; the device produces a reading that is then compared to a reference standard.

7. The Type of Ground Truth Used

• SpO2 Accuracy: Ground truth was established using a laboratory co-oximeter in human blood studies during induced hypoxia.
• Pulse Rate Accuracy: Ground truth was established using an ECG monitor.
• Low Perfusion Accuracy: Ground truth was established using bench top testing against a Biotek Index 2 simulator and Masimo's simulator with controlled saturation and signal strengths.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The Masimo SET® technology is described as "clinically proven" and "Masimo SET technology performance." Given the nature of a pulse oximeter, its algorithms are likely developed and refined through extensive R&D and calibration rather than a distinct "training set" as understood in modern AI/ML development. The studies mentioned are primarily for validation of the device's accuracy against established physiological measurements.

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

As no specific "training set" for an AI/ML model is described, this question is not directly applicable. The underlying "Masimo SET® Technology" itself would have been developed and refined using a combination of physiological understanding, signal processing, and iterative testing, with ground truth established through similar methods as the validation studies (e.g., co-oximetry, ECG).

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