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The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.

The CARESCAPE SpO2 - Masimo is indicated for the monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 - Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE SpO2-Masimo (module) is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to monitor Masimo pulse oximeters (SpO2 and PR). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

The CARESCAPE SpO2 - Masimo is equipped with the same Masimo Technology Board as the predicate device (K200494), which provides the Masimo SET Technology for the measurement and monitoring of pulse oximetry data.

The module is labeled CARESCAPE SpO2 – Masimo or GE CARESCAPE SpO2 – Masimo. Both versions are identical except for the labeling to distinguish the version distributed by Masimo. The purpose of this submission is to receive clearance to market CARESCAPE SpO2 - Masimo under its own 510(k).

The provided text describes the CARESCAPE SpO2 - Masimo device, whose 510(k) submission (K212876) is for a labeling update and to market the device under its own 510(k). The device itself is identical to the primary predicate device, GE CARESCAPE SpO2 – Masimo (part of K200494), with no changes to hardware, software, or performance. Therefore, new performance data was not generated for this submission.

The acceptance criteria provided in the document are the performance specifications of the device as previously cleared with the predicate device.

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

Since this submission is for a device that is identical to a previously cleared predicate, the "reported device performance" refers to the previously established performance specifications which are considered met, as there are no changes to the device itself.

2. Sample size used for the test set and the data provenance

The document explicitly states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the primary predicate device, additional testing was not considered necessary to support the substantial equivalence."

Therefore, no new test set was used for this particular submission. The performance data is derived from the testing conducted for the primary predicate device (K200494), but the details of that testing (sample size, data provenance) are not provided in this document.

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

Not applicable for this submission as no new testing was performed to establish ground truth.

4. Adjudication method for the test set

Not applicable for this submission as no new testing was performed to establish ground truth that would require 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 an oximeter, not an AI-assisted diagnostic tool.

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

The performance specifications listed are standalone performance metrics of the oximeter device. Details of the studies establishing these specifications were conducted for the predicate device, but are not described in this document.

7. The type of ground truth used

For an oximeter measuring SpO2 and Pulse Rate, the ground truth typically involves invasive blood gas analysis (for SpO2) and ECG or simultaneous direct measurement (for Pulse Rate) against which the device's measurements are compared. These methods would have been used during the original testing of the predicate device.

8. The sample size for the training set

Not applicable. This document is for a medical device (oximeter), not an AI model requiring a training set. The device operates on physical principles, not machine learning.

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

Not applicable.

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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.

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