Search Results

The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is intended to be used with compatible Philips Intellivue Patient Monitors. The indications for use as specified for the Intellivue Patient Monitors applies.

The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Masimo Rainbow SET® Intellivue Module Pulse CO-Oximeter is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The subject device, Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (Rainbow IVM), resulted from simply taking the same Masimo Rainbow SET technology included in the primary predicate, Philips Multi-Measurement Module (MMS), cleared under K150975 and putting the Masimo Rainbow SET technology into the same form factor as the reference predicate, Masimo Intellivue Pulse Oximeter Module (IVM), cleared under K040259. The resulting Rainbow IVM provides continuous, noninvasive measurements of functional oxygen arterial hemoglobin (SpO2), pulse rate, perfusion index (PI), pleth variability index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen content (SpOC) and respiration rate (RRa). The Rainbow IVM is intended to be used with compatible host monitors, Philips Monitors (K150975). Hence, the Rainbow IVM can be used in the same environment that the Philips Monitors are used. Furthermore, the subject device does not have its own power. monitoring alarms or display and must rely on the host monitor for those capabilities.

The document describes the Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (Rainbow IVM) and its substantial equivalence to predicate devices, K150975 and K040259. However, it explicitly states that no clinical testing was done to demonstrate the device meets acceptance criteria. The submission relies solely on non-clinical testing.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies cannot be extracted from the provided text.

Based on the provided information, here's what can be answered:

1. A table of acceptance criteria and the reported device performance

The document lists "Measurement Accuracy" specifications in the "Rainbow IVM Specifications" table, which serve as the acceptance criteria for performance. The "reported device performance" is essentially that these specifications are met based on non-clinical testing (although specific results of that testing are not detailed beyond a general statement that "all requirements and performance specifications were satisfied").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical testing was performed for the Rainbow IVM device.

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

Not applicable. No clinical testing was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical testing was performed.

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. No clinical testing was performed, and the device is a measurement module, not an AI-assisted diagnostic tool for human readers.

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

The device is a non-invasive physiological monitoring device. Its "performance" refers to the accuracy of its measurements (SpO2, SpCO, SpMet, SpHb, RRa, etc.) against a reference, which would typically be measured in a controlled environment or in clinical studies. The document states "no clinical testing was done," meaning no standalone clinical performance study was conducted on this specific device. However, the performance specifications listed are for the device (algorithm and hardware) itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated for the non-clinical testing. For physiological measurements like these, ground truth would typically come from a clinical reference standard (e.g., co-oximetry for SpO2, SpCO, SpMet, SpHb, or capnography/direct observation for RRa) during clinical trials or controlled laboratory settings (e.g., human desaturation studies for SpO2). Since no clinical testing was performed for this specific submission, the "ground truth" for the non-clinical tests would refer to the expected electrical and optical signals/simulations used to verify the device's adherence to its specifications.

8. The sample size for the training set

Not applicable. No clinical testing was performed, and a "training set" is typically associated with machine learning or AI models, which is not directly indicated here. The device relies on established principles of spectrophotometry and acoustic monitoring.

9. How the ground truth for the training set was established

Not applicable. No clinical testing was performed or described.

Ask a specific question about this device