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Nihon Kohden's model number OGS-2001A is intended for medical use to measure the blood oxygen saturation (SpO2) and to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status (CO2).

This product will be available for use by medical personnel within a medical facility or in a remote environment including transport. This device is not intended to be the sole basis of diagnosis.

The CO2 function of the device is intended for patients three (3) years and above and is not recommended for patients with low tidal volume such as patients weighing less than 22 pounds or patients with a respiratory rate greater than 60 breaths per minute. The CO2 function will be available for all other patient populations.

The OGS-2001A device is not sterile. The airway adapter is for single patient use only. Reusable or single patient use SpO2 probes are available.

The device material components have been determined to be non-contacting per the quidance provided by BS EN 30993: 1994 / ISO 10993: 1993 which replaces the Tripartite Guidance. The reusable SpO2 probe surface is silicone, known to be biocompatible by over 30 years of various medical device uses per the open literature. The disposable, SpO2 probes are the same probes as used with the predicate device BSM-1101 (K973918). Therefore, good laboratory practice studies were not required per 21 CFR 58.

The OGS-2001A PocketCare was subjected to electromagnetic, environmental, safety and performance testing procedures per Nihon Kohden design control requirements. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring. processing, displaying and recording all functions of the results confirmed that the device performed within specifications.

Here's an analysis of the provided text regarding the OGS-2001A PocketCare device, addressing your specific questions:

This document is a 510(k) submission for the Nihon Kohden OGS-2001A PocketCare, a medical device intended to measure blood oxygen saturation (SpO2) and carbon dioxide concentration (CO2).

1. Table of acceptance criteria and the reported device performance

The provided text does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision) for either SpO2 or CO2 measurements. It states that:

• "Software validation tested the operation of the software functions of acquiring, processing, displaying and recording all functions of the results confirmed that the device performed within specifications."

This indicates that the device met its internal specifications, but these specifications themselves are not detailed in the provided documents.

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

The document does not provide details on the sample size for a test set, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on verifying compliance with design controls, software validation, and substantial equivalence to predicate devices, rather than a clinical performance study with human subjects for independent validation of accuracy.

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

The document does not describe any process involving experts to establish a "ground truth" in the context of a clinical test set. The validation described is related to engineering and software performance against internal specifications.

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

Since no clinical test set with expert ground truth establishment is described, there is no adjudication method mentioned.

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

This document is for a basic SpO2/CO2 monitoring device. It does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it involve AI assistance in the way typically understood for such studies.

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

The document describes "software validation tested the operation of the software functions of acquiring, processing, displaying and recording all functions of the results." This statement suggests that the standalone performance of the device's algorithms and software was indeed tested against its specifications. However, the specifics of these tests (e.g., using simulated data, phantom measurements, or patient data) are not detailed.

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

The document does not explicitly state the type of "ground truth" used for performance validation. Given the nature of SpO2 and CO2 measurements, it's highly probable that:

• For SpO2: co-oximetry (blood gas analysis) would be the gold standard "ground truth" in any clinical accuracy study, but such a study is not detailed here.
• For CO2: validated gas mixtures or a reference gas analyzer would be used as "ground truth" for calibration and accuracy testing.

The document refers to "specifications," implying that performance was compared against these predefined standards, which would have been established based on accepted physiological principles and potentially reference methods, but this is not explicitly called out as "ground truth" in the provided text.

8. The sample size for the training set

The document does not mention a "training set" as this device does not appear to utilize machine learning or AI models that require data training in the modern sense. Its validation is based on traditional engineering and software verification methods.

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

As there is no training set mentioned, the method for establishing its ground truth is also not applicable.

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