Search Results

The Nihon Kohden TG-970P and 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 and is available for use on any patient weighing 2kg or more.

The TG-970P Series CO2 Sensor Kit 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. The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the CO2 adapter. The adapter then reads the data and converts the data so it can be displayed on the patient monitor.

Here's a breakdown of the acceptance criteria and study information for the Nihon Kohden TG-970P Sensor Kit with the new Airway Adaptor, based on the provided document:

Acceptance Criteria and Device Performance

The core of this submission is about demonstrating that the new YG-213T airway adapter for the existing TG-970P CO2 Sensor Kit is substantially equivalent to the predicate device, specifically extending its use to smaller patients (2kg to 7kg). The acceptance criteria are implicitly tied to maintaining the accuracy and safety established by the predicate device (TG-970P with YG-211T) for this new patient population.

Table of Acceptance Criteria and Reported Device Performance

Study Information

The document describes a "verification and validation testing" process to demonstrate substantial equivalence, rather than a formal human clinical trial in the traditional sense.

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

   • Sample Size: The document does not specify the sample size for the test set used in the verification/validation testing.
   • Data Provenance: The document does not explicitly state the country of origin for the data. Given the company (Nihon Kohden Corporation) and Nihon Kohden America, Inc. being the sponsor, it's likely the testing was conducted by or in collaboration with the manufacturer, potentially in Japan or the US, but this is not confirmed. The study appears to be retrospective in the sense that the testing was performed to validate a design change rather than a new device from scratch with prospective patient enrollment. However, the exact nature of the testing (e.g., simulated breath patterns, animal models, limited human subjects) is not detailed.

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

   • The document does not mention the use of experts to establish ground truth for a test set. This type of device relies on objective physical measurements of CO2 concentration rather than subjective interpretation like medical images. Ground truth would typically be established by a highly accurate reference gas analyzer or a calibrated gas mixture.

3. Adjudication Method for the Test Set:

   • Not applicable. As the "ground truth" for a CO2 sensor is a quantitative physical measurement (e.g., from a reference gas analyzer or known gas concentration), an adjudication method by human experts is not relevant.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and comparing human performance with and without AI assistance. The Nihon Kohden TG-970P is a CO2 sensor, which provides objective physiological measurements, not an AI-assisted diagnostic tool for human interpretation.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, implicitly. The "verification and validation testing" performed by Nihon Kohden to confirm the accuracy of the measured gas and the substantial equivalence to the predicate device would be a standalone performance assessment of the device, independent of human operators, beyond the normal operation. The device essentially is the algorithm/measurement system for CO2 concentration. However, it's important to clarify that this isn't an "AI algorithm" in the conventional sense (e.g., for image recognition or predictive analytics), but rather the performance of a physical sensor and its associated signal processing.

6. Type of Ground Truth Used:

   • The ground truth would have been established using reference gas mixtures with known CO2 concentrations or a highly accurate and calibrated reference CO2 analyzer. The document refers to "accuracy of the measured gas," implying comparison against a standard. It does not mention pathology or outcomes data.

7. Sample Size for the Training Set:

   • Not applicable in the typical AI/ML sense. The Nihon Kohden TG-970P is a hardware device based on infrared absorption principles, not a machine learning algorithm that undergoes a "training" phase with a dataset. The design and calibration would have been based on physical principles and engineering specifications, not statistical learning from a training set.

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

   • Not applicable. See point 7.

Ask a specific question about this device