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The Nihon Kohden TG-970P CO2 sensor kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.

The device is intended for use by qualified medical personnel within a hospital or clinical environment.

The TG-970P CO2 Sensor Kit measures the partial pressure of the expired CO2 of the patient by measuring the amount of absorbed CO2 infrared light, using a CO2 feature which absorbs infrared light. It is comprised of three main components; a CO2 Sensor (photo detector and light emitter) with cable and connector, a CO2 adapter and an airway adapter (YG-211T, YG-213T and YG-214T) or mask (YG-232T and YG-242T).

The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. It detects the infrared light from the light emitter which passes through the expired air in the airway adapter and calculates the partial pressure of the expired CO2. The photo detector and light emitter end of the CO2 Sensor is connected to the airway adapter or mask. The airway adapter is then connected between the patient airway and the respirator. The CO2 adapter processes the electrical signal of the detected infrared light into digital data which is sent to the instrument.

The provided text describes a 510(k) premarket notification for the Nihon Kohden TG-970P CO2 Sensor Kit. The submission focuses on demonstrating substantial equivalence to a predicate device (K122214) rather than presenting a detailed acceptance criteria table and a comprehensive study for a novel device. Therefore, much of the requested information cannot be directly extracted as it pertains to AI/algorithm-based devices or detailed clinical performance studies, which are not the primary focus of this submission.

However, I can extract information related to the changes made and the testing performed to demonstrate substantial equivalence for the modified device.

Here's the breakdown of the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence through design verification/validation testing of the modifications made to the device, particularly the new airway adapter and durability improvements. It doesn't present a table of specific acceptance criteria with corresponding performance metrics in a quantitative manner typical of a new device's performance study. Instead, it states that modifications "do not impact the intended use of the device" or are "equivalent in safety and effectiveness."

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

The document mentions "bench testing," "design verification/validation testing," and "clinical evaluation for prototype of a new neonatal airway adapter." However, specific sample sizes (e.g., number of test specimens, number of patients) for these tests are not provided. The provenance of the data is generally from the manufacturer, Nihon Kohden Corporation (Japan and USA). The nature of the studies ("clinical evaluation for prototype") suggests prospective testing, but without detailed protocols, it's hard to confirm.

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

This information is not provided. The testing described appears to be primarily benchtop and engineering design verification, which might not involve external experts in the same way clinical ground truth establishment for AI models would.

4. Adjudication method for the test set:

This information is not applicable/provided. The studies described are not focused on interpreting results where adjudication by multiple experts would be needed.

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 is not applicable. The device is a CO2 sensor kit, not an AI-assisted diagnostic tool involving human readers.

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

While the device (CO2 sensor) operates in a "standalone" fashion to measure CO2, the concept of "standalone performance" as it applies to AI algorithms is not applicable here. The sensor provides raw data (CO2 concentration) to aid medical personnel.

7. The type of ground truth used:

For the performance testing, the "ground truth" would implicitly be established through engineering measurement standards and validated measurement techniques (e.g., highly accurate CO2 gas analyzers or calibrated flow and gas systems for bench testing). For the "clinical evaluation," the ground truth for physiological parameters (like CO2 in expired air) would be the actual physical/chemical concentration measured by a reference method. The document states, "The TG-970P CO2 Sensor Kit... is capable of accurately measuring CO2 in the patient's airway during expiration," implying a comparison against an accurate reference.

8. The sample size for the training set:

This is not applicable. The device is not an AI/machine learning algorithm that requires a training set.

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

This is not applicable. The device is not an AI/machine learning algorithm that requires a training set.

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