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The Rainbow Adhesive Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Adhesive Sensors are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI and Direct Connect (Reusable) Sensors in the K080238 filing and the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing.

The Rainbow Adhesive Sensors in this filing have the same intended use/indications for use and performance specifications as the Rainbow Reusable Sensors in the K080238 filing. However, The Rainbow Adhesive Sensors in this filing are similar in construction to the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing. The main difference is that the sensors in the K071024 filing have 8wavelengths and the sensors in this filing have 12-wavelengths.

Similar to the 8-wavelength sensors in this filing include the emitter and detector assemblies connecting to the flex circuit, and an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. Sensor sizing for use with adult, pediatric, infant, and neonatal patients are the same for the sensors in the K071024 and for the sensors in this filing. The patient-contact materials in the Rainbow Adhesive Sensors in this filing are the same that is used in the K071024 filing. Also similar to the sensors in the K071024 filing, the Rainbow Adhesive Sensors in this filing are supplied non-sterile for single patient use.

Here's a breakdown of the acceptance criteria and the study details for the Rainbow Adhesive Pulse CO-Oximeter Sensors (K081659):

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document implies the acceptance criteria are met by stating the device "resulted in an accuracy of" a specific value. Given this is a 510(k) submission for substantial equivalence, the acceptance criteria would typically be aligned with the performance of the predicate devices or established standards.

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

• Sample Size for Test Set: Not explicitly stated as a number. The clinical studies included:
  • "healthy adult volunteer subjects during motion conditions who were subjected to a progressive induced hypoxia"
  • "human blood studies on adult volunteers" for SpCO, SpMet, and SpHb.
  • "hospitalized neonatal patients"
• Data Provenance: The studies were described as "clinical studies" and "human blood studies" using "healthy adult volunteer subjects" and "hospitalized neonatal patients." While the country of origin is not explicitly stated, the submission is to the U.S. FDA, implying the studies were conducted in a manner compliant with U.S. regulatory standards, likely in the U.S. The studies were prospective as they involved inducing hypoxia and taking blood samples.

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

• Number of Experts: Not applicable/not experts.
• Qualifications of Experts: The ground truth was established by a "laboratory CO-Oximeter" measuring arterial blood samples, not by human experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established through direct measurement by a laboratory CO-Oximeter against arterial blood samples. There was no mention of human-based adjudication.

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

• Was an MRMC study done? No. This device is a sensor that provides automated measurements. Human readers are not involved in interpreting the output of the device in a way that an MRMC study would assess.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? Yes. The clinical performance testing described focuses on the accuracy of the "Masimo Rainbow SET technology with Rainbow Adhesive Sensors" against a laboratory standard, which is a standalone performance assessment of the device.

7. Type of Ground Truth Used

• Ground Truth Type: Objective, direct measurement. The ground truth for all reported parameters (SpO2, SpCO, SpMet, SpHb) was established by a laboratory CO-Oximeter analysis of arterial blood samples.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated. The document describes clinical studies that are primarily for validation (test set) rather than directly detailing a training set for the algorithm. For a device like this, the "training" data would likely be used in the original development and refinement of the Masimo Rainbow SET technology itself, which is referenced as already established. This submission focuses on validating the performance of a new sensor type (12-wavelength) with the existing technology.

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

• How Ground Truth for Training Set was Established: Not explicitly detailed in this 510(k) summary. For similar optical technologies, the ground truth for training would typically involve large datasets of paired non-invasive measurements and corresponding invasive arterial blood gas measurements using laboratory-grade CO-Oximeters, similar to how the test set ground truth was established. This data would then be used to develop and refine the algorithms (e.g., spectral analysis, calibration coefficients). However, this specific filing focuses on the validation of the new sensor, presuming the underlying algorithm of the Rainbow SET technology is already established and has its own associated training data.

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