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Model X-100C
Nonin's Model X-100C CO-Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. The X-100C system is indicated for use by trained personnel in clinical settings, including Emergency Medical Service (EMS). hospitals, medical facilities, and mobile environments. 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.

Model 8300AA
The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of function of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (> 66 lbs / 30 kg). The measurements may be multiple spot-checks to observe change and/or continuous monitoring. It is intended for use in Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments. 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.

The Model X-100C CO-Met Oximetry System displays (COHb), methemoglobin (MetHb), pulse oxygen saturation (SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of the signal processor to the monitor. The monitor receives, displays, provide alarm management, and storage of COHb, MetHb, SpO2, and PR. The device is capable of running on battery power or on AC power via an external power supply. The device is equipped with patient alarms to alert the user to abnormal conditions and shall provide real time data output of COHb, MetHb, SpO2, and PR.

The provided document describes the acceptance criteria and the study conducted for the Nonin Medical, Inc. Model X-100C CO-Met™ Oximetry System (K160231).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references ISO 80601-2-61 for accuracy calculations (root-mean-squared, Arms value). While specific numerical acceptance criteria (e.g., maximum Arms value for each parameter) are not explicitly stated in a consolidated table, the performance is reported against these implicit criteria derived from the standard.

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

• Sample Size: Not explicitly stated as a number of subjects. The clinical accuracy testing sections mention "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." They refer to "all subjects" in the accuracy calculation but do not provide a specific count.
• Data Provenance: Retrospective or prospective is not explicitly stated. However, the description of "COHb accuracy testing was conducted at an independent research laboratory," "MetHb accuracy testing was conducted at an independent research laboratory," and "induced hypoxia studies" suggests a prospective study design where subjects were enrolled and data collected for the purpose of the study. The location is an "independent research laboratory." The country of origin is not specified but is implicitly within the scope of a U.S. FDA submission.

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

Not applicable for this type of medical device. The ground truth for oximetry is established through a co-oximeter analyzing arterial blood samples, not through expert consensus on images or clinical assessments in this context.

4. Adjudication method for the test set

Not applicable. The ground truth is objective measurement from a co-oximeter analysing blood samples.

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 a standalone oximetry system and does not involve human readers interpreting images with or without AI assistance.

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

Yes, the primary performance evaluation described is for the standalone device (Model X-100C CO-Met™ Oximetry System with 8300AA sensors) without an explicit human-in-the-loop component for interpreting the raw measurements; the device generates direct readings. The accuracy studies directly compare the device's measurements to the co-oximeter's measurements of arterial blood.

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

The ground truth for COHb, MetHb, and SpO2 measurements was established using laboratory co-oximetry analysis of simultaneous arterial blood samples.

8. The sample size for the training set

Not applicable. This refers to a medical device for direct measurement, not an AI/machine learning algorithm that requires a training set. The device's performance is based on its sensor technology and signal processing.

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

Not applicable, as there is no training set for this type of device.

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