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The OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2.

The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits, or when a technical error is detected.

The devices are intended to be used by qualified medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.

The Nihon Kohden OLG-3800A is a compact CO2 monitor with a 7-inch display and is designed so the operator can directly touch the screen from the operator position. The CO2 monitor displays the patient's vital signs (CO2, RR, SpO2, PR) on the screen and generates an alarm according to the setting. Alarms are indicated with a screen message, sound, blinking or lighting of the alarm indicator. The device is used with commercially available sensors for intubated and non-intubated patients. The CO2 monitor is intended to be used in an ER, OR, ICU, CCU or general ward on all patient populations, depending on the accessories used with the device. The OLG-3800A is AC and/or battery operated.

When the operation mode is set to Network mode, the CO2 monitor can connect to a Nihon Kohden monitoring system network and communicate with the central monitor and bedside monitor on the network.

A new optional accessory, single-use adult cap-ONE Biteblock YG-227T can be used together with OLG-3800. YG-227T is inserted between the patient's teeth to prevent closure of the patient's jaws. It connects to a specified Nihon Kohden CO2 sensor kit to measure the partial pressure of the expired CO2 of a patient. Also, it allows oxygen (including an oxygen-air mixture) to be provided to the patient during endoscopy.

This document describes the Nihon Kohden CO2 Monitor, Model OLG-3800A, and its substantial equivalence to predicate devices. However, it does not contain a typical study design with the elements requested (acceptance criteria, device performance, sample size, ground truth, expert involvement, etc.) for an AI/ML-based medical device. Instead, it details the device's technical specifications, indications for use, and compliance with various international standards for medical electrical equipment and a brief section on performance testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of regulatory submission (a 510(k) for a hardware medical device with standard electrical and performance testing against a predicate device, not an AI/ML algorithm requiring a clinical validation study with human readers or standalone performance metrics).

However, I can extract information related to the device's stated performance and compliance with relevant standards, which serve as its "acceptance criteria" in this context.

Here's the information that can be extracted or inferred based on the provided document:

1. A table of acceptance criteria (from standards) and the reported device performance:

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

• The document mentions "performance testing" and "software verification and validation test, software unit test, integration test." It also states, "It has been verified using standard ISO 80601-2-61:2011" for SpO2.
• However, specific sample sizes for these tests or data provenance (e.g., country of origin, retrospective/prospective) are not provided as this is not a clinical study on patient data for AI/ML. The testing likely refers to bench testing, functional testing, and electrical/software validation according to the listed standards.

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

• This information is not applicable and therefore not provided. The device's performance is validated against established physical/electrical/optical standards and measurement accuracy, not against expert interpretation of medical images or data.

4. Adjudication method for the test set:

• This information is not applicable and therefore not provided. It is not an expert-based review but a technical validation against specifications and standards.

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 information is not applicable. The device is a monitor, not an AI-assisted diagnostic tool that would be used by human "readers" (like radiologists interpreting images). It provides direct physiological measurements.

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

• The device itself is standalone in terms of its measurement function. It operates as an algorithm-only device (its internal processing) for measuring physiological parameters. Its performance is evaluated against the accuracy specifications derived from the standards mentioned (e.g., ISO 80601-2-55 for CO2, ISO 80601-2-61 for SpO2). The provided performance ranges (e.g., CO2 accuracy range, SpO2 accuracy range) represent its standalone performance.

7. The type of ground truth used:

• The "ground truth" for this monitoring device is based on reference measurement standards and calibrated equipment used in engineering and electrical safety testing, as well as the specific accuracy limits defined in the referenced ISO and IEC standards for CO2 and SpO2 monitoring. For example, SpO2 measurement "has been verified using standard ISO 80601-2-61:2011," which outlines methods and criteria for evaluating oximeter accuracy.

8. The sample size for the training set:

• This information is not applicable and therefore not provided. This is not an AI/ML device that undergoes "training" on a dataset in the conventional sense. Its internal algorithms are developed and calibrated based on engineering principles and physiological models, not machine learning from a large training dataset.

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

• This information is not applicable for the same reasons as #8.

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