MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

• K Number: K033296
• Device Name: MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
• Manufacturer: MASIMO CORP.
• Date Cleared: 2004-02-19 ( 128 days)
• Product Code: DQA
• Regulation Number: 870.2700
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K031330

Intended Use

The Masimo SET® RAD-5 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.

The Rad-5 Handheld Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (Sp() ) and pulse rate (measured by an SpO2 sensor). The Rad-5 Handheld Pulse Oximeter is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The Masimo SET® Rad 5 Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and ition conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Description

The Masimo SET® Rad-5 Pulse Oximeter is a handheld pulse oximeter that measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It utilizes spectrophotometry and plethysmography principles. The device displays SpO2, pulse rate, alarm status, alarm silenced status, Perfusion Index Bar, Signal IQ Bar, Battery Status, APOD, and FastSat. It has adjustable alarm volume and averaging settings. It is powered by 4 AA batteries.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Masimo SET® Rad-5 Pulse Oximeter, based on the provided text:

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Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Study Endpoint)	Reported Device Performance
Saturation (% SpO2) - No Motion
Adults, Pediatrics	70% - 100% ± 2 digits	Met: within ± 2 digits (70%-100% range)
Neonates	70% - 100% ± 3 digits	Met: within ± 3 digits (70%-100% range, based on 83%-100% neonatal data combined with adult studies)
Saturation (% SpO2) - Motion
Adults, Pediatrics	70% - 100% ± 3 digits	Met: within ± 3 digits (70%-100% range)
Neonates	70% - 100% ± 3 digits	Met: within ± 3 digits (70%-100% range, based on neonatal data combined with adult studies)
Pulse Rate (bpm) - No Motion
Adults, Pediatric, Neonates	25-240 bpm ± 3 digits	Met: within ± 3 digits (25-240 bpm range)
Pulse Rate (bpm) - Motion
Adults, Pediatric, Neonates	25-240 bpm ± 5 digits	Met: within ± 5 digits (25-240 bpm range)
Low Perfusion Performance	SpO2: ± 2 digits; Pulse Rate: ± 3 digits (for > 0.02% Pulse Amp & > 5% Transmission)	Met: (implied by statement that technology was "validated for low perfusion accuracy")
Environmental Testing	Per Reviewers Guidance for Premarket Submissions - November 1993	Met: All tests passed (electrical, mechanical, environmental)

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Study Details

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of subjects. The studies were conducted on:
     • Healthy adult volunteers (for no motion, motion, and low perfusion conditions).
     • Neonates (for no motion, motion, and low perfusion conditions).
   • Data Provenance: The studies were described as "human blood studies" and were clinical tests. The location is not specified, but given the company is based in Irvine, CA, and the FDA approval process, they were likely conducted in the US. The studies are prospective, involving "induced hypoxia states."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. The ground truth was established by a laboratory co-oximeter and an ECG monitor, not human experts for interpretation.
   • Qualifications of Experts: N/A.

3. Adjudication method for the test set:

   • Not applicable. The ground truth in this case is objective physiological measurements from a laboratory co-oximeter and an ECG monitor, not subjective interpretations requiring adjudication.

4. 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 study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that relies on human readers' interpretation.

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

   • Yes, this was a standalone performance study. The device's accuracy was directly compared against a physiological ground truth (co-oximeter and ECG) under various conditions. The device's algorithm performs the measurements and calculations independently to determine SpO2 and pulse rate.

6. The type of ground truth used:

   • Clinical Ground Truth:
     • Co-Oximetry (Laboratory Co-Oximeter): Used to determine arterial hemoglobin oxygen saturation (SaO2) through arterial blood samples. This is considered the gold standard for oxygen saturation measurement.
     • Electrocardiogram (ECG Monitor): Used to determine true pulse rate.

7. The sample size for the training set:

   • The document implies that the "values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions." This suggests that a dataset of human blood studies was used to develop and refine the algorithm's look-up table. However, the specific sample size of this training set is not explicitly stated.

8. How the ground truth for the training set was established:

   • As indicated in the "Principles of Operation" section, the "values in the look-up table" (which essentially represent the training data for the internal algorithm's calibration) were based on:
     • Human blood studies: Healthy adult volunteers were subjected to induced hypoxia states.
     • Comparison against a laboratory co-oximeter: Arterial blood samples were analyzed by a co-oximeter to provide the true oxygen saturation (SaO2) values.
     • This process was performed under both motion and non-motion conditions to build a robust look-up table for the device's internal calculations.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).