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The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

· For %SpO2 and pulse rate, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings.

· For %rSO2, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings.

· For %COHb and %MetHb, the H500 System is intended for spot-checking, multiple spot-checks to observe change, and/ or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings.

The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is a small handheld wireless device intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2) of adult, pediatric and neonate patients. It is intended for professional use only, in healthcare facilities, mobile and EMS environments. The system is not provided sterile and is not a reprocessed single-use device. The H500 System consists of three components which are the display, the signal processor and associated sensors. It is intended to be used with specific parts, accessories and compatible sensors which are outlined in Table 1 below.

The Nonin Medical CO-Pilot Model H500 Multi-Sensing Oximetry System is intended for non-invasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). The device underwent comprehensive testing to establish its accuracy and substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are based on the root-mean-squared (Arms) value, calculated per ISO 80601-2-61, for each physiological parameter. While the specific numerical acceptance criteria (e.g., maximum allowable Arms value) are not explicitly stated in the provided text, the document indicates that the device "meets all testing acceptance criteria." The described performance is the result of applying the stated methods and the device passing these criteria.

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

• COHb, MetHb, SpO2 (no motion), SpO2 (with COHb and MetHb):
  • Sample Size: "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified, but the testing was "for all subjects."
  • Data Provenance: Prospective, conducted at an "independent research laboratory." The country of origin is not specified but it's an FDA submission, implying a US-based or internationally recognized standard for testing.
• rSO2 (8004CA/8204CA sensors):
  • Sample Size: "healthy, non-smoking, light- to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified, but the testing was "for all subjects."
  • Data Provenance: Prospective, conducted during "induced hypoxia studies." The location is not specified, but implicitly an independent research laboratory.
• rSO2 (8004CB/8004CB-NA sensors):
  • Sample Size: "sick, male and female, pediatric patients ranging in age from 4 days to 10 years with light- to dark-skin." The exact number of subjects is not specified, but the testing was "for all subjects."
  • Data Provenance: Prospective, conducted in "cardiac catheterization laboratories." The location is not specified but implicitly an independent research laboratory.

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

The ground truth for all clinical accuracy testing was established using laboratory CO-oximetry for COHb, MetHb, and SpO2, and arterial/venous blood gas analysis for rSO2. This method relies on validated laboratory equipment rather than human expert consensus. Therefore, the concept of "number of experts" is not directly applicable in the same way it would be for image interpretation tasks. However, the operation and interpretation of these laboratory gold standard devices would have been performed by qualified laboratory personnel. Specific qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not applicable as the ground truth was established by objective laboratory measurements (CO-oximetry and blood gas analysis), not via human expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the measurement accuracy of the device itself against established reference methods, not on how human readers' performance might improve with or without AI assistance from this specific device. The device is a multi-sensing oximetry system, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC reader study to assess human-AI symbiosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical accuracy testing described for COHb, MetHb, SpO2, and rSO2 are standalone performance studies. The device's measurements were directly compared against the "gold standard" laboratory methods (CO-oximetry and blood gas analysis) to determine its accuracy without human interpretation influencing the measurement outcome. The device itself is an algorithm-driven measurement system.

7. The Type of Ground Truth Used

• For %COHb, %MetHb, %SpO2, and %SpO2 in presence of COHb and MetHb: The ground truth was objective laboratory measurements from arterial blood samples as assessed by CO-oximetry.
• For %rSO2: The ground truth was objective laboratory measurements from venous and arterial blood samples as assessed by blood gas analysis, modeling blood in the brain as 70% venous and 30% arterial.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set sample size. This suggests the device's underlying signal processing algorithms were developed and validated independently or through proprietary methods not detailed in this 510(k) summary. The clinical accuracy studies described are test set evaluations for regulatory submission.

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

Information on how the ground truth for any potential training set was established is not provided in this document.

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