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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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The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. 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 multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg).
• For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.

Nonin Medical's Multi-Sensing Oximetry system, when used with Model 8330AA reusable finger clip sensor, is based on Nonin's SenSmart™ technology platform, displays (%COHb), pulse oxygen saturation (%SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of a signal processor to the monitor. The model 8330AA sensor provides real time data output of COHb, SpO2, and PR.

Here's a breakdown of the acceptance criteria and study details for the Nonin Medical Inc. Multi-Sensing Oximetry System with Model 8330AA Sensor, extracted from the provided text:

This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely in the context of demonstrating performance comparable to the predicate and compliance with relevant medical device standards, rather than an AI-specific set of metrics. The study described is a clinical accuracy study for a medical device (oximeter), not an AI algorithm. As such, many of the typical AI-specific sections (experts establishing ground truth, MRMC study, training set details) will not be applicable.

Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated against its ability to accurately measure %SpO2, %COHb, and pulse rate, in comparison to a gold standard (co-oximetry) and in demonstration of equivalence to its predicate device. The Acceptance Criteria are implicitly defined by the stated accuracy specifications and the results demonstrating compliance ("Pass") with various international standards for medical electrical equipment.

Table 1: Key Performance Metrics & Compliance (Based on Text)

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The text states clinical accuracy testing for COHb and SpO2 was conducted on "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 in the provided text.
   • Data Provenance: The studies were "conducted at an independent research laboratory." The country of origin is not explicitly stated, but given the FDA submission, it is typically presumed to be from the US or a country with comparable regulatory and ethical standards. The studies were prospective as they involved induced conditions (COHb, hypoxia) and direct comparison to simultaneously collected arterial blood samples.

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

   • This is not an AI/imaging study requiring expert radiologist consensus. The ground truth for oximetry is established through objective laboratory measurements: specifically, arterial blood samples assessed by co-oximetry. Therefore, the concept of "experts establishing ground truth" in the sense of clinical interpretation (like radiologists for an AI model) is not applicable here. The "experts" would be the trained laboratory personnel performing the co-oximetry and blood sampling, whose qualifications are essential for the validity of the lab measurements.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of this device and study type. Ground truth for blood gas measurements is established by a direct analytical method (co-oximetry) on blood samples, not by human interpretation or consensus.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. This is a medical device (oximeter) accuracy study comparing device readings to a gold standard (co-oximetry), not an AI diagnostic aid study involving human readers interpreting images.

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

   • Yes, in essence. The accuracy testing (%COHb, %SpO2, Pulse Rate) described is the direct performance of the device's sensing and processing capabilities (its "algorithm") compared to the scientifically accepted gold standard (co-oximetry). There isn't a "human-in-the-loop" aspect to the device's direct measurement of these physiological parameters.

6. The Type of Ground Truth Used:

   • The ground truth used was objective laboratory measurements from arterial blood samples, specifically assessed by co-oximetry. This is a direct, quantitative biochemical measurement.

7. The Sample Size for the Training Set:

   • This is not an AI/machine learning model where a distinct "training set" is typically used in the same way. The device's underlying technology (Nonin's SenSmart™ platform) is likely developed and validated through extensive internal research and development, which implicitly involves a large amount of raw data to refine the algorithms for signal processing and parameter estimation. However, the document does not specify a "training set" in the context of an AI model being submitted for pre-market review. The clinical accuracy studies described are specifically for performance validation (test set equivalent).

8. How the Ground Truth for the Training Set Was Established:

   • As above, the concept of a "training set" with established ground truth as understood for AI models is not directly applicable to this type of medical device submission. The underlying principles for determining SpO2 and COHb involve spectrophotometry, which relies on known absorption characteristics of different hemoglobin species. The "ground truth" for developing such a device would be derived from fundamental physiological and optical principles, corroborated by empirical data from controlled studies using reference methods like invasive co-oximetry, but it's not described as a separate, labeled "training set" with ground truth in this document.

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