(152 days)
The Nihon Kohden TG-901T CO2 Sensor 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. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis.
The Nihon Kohden CO2 Sensor Kit, model number TG-901T, 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. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis.
The provided text for the Nihon Kohden TG-901T CO2 Sensor Kit does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (OLG-1100A PocketCap CO2 Monitor) rather than presenting a performance study with defined acceptance criteria for the new device.
Here's a breakdown of what can and cannot be extracted from the given text based on your request:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861."
- It mentions "electromagnetic, environmental, safety and performance testing procedures" were done and "verified the operation of the device," but no specific acceptance criteria or performance results (e.g., accuracy, precision, bias) are reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe a clinical or performance test set with sample sizes, data provenance, or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No information on experts or ground truth establishment is present as no specific test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is mentioned as there's no described test set requiring it.
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
- Cannot be provided. This device is a CO2 sensor, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related metrics are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The device is a sensor, not an algorithm in the context of typical standalone AI performance. Its "performance" would relate to its measurement accuracy, which is not detailed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth type is mentioned as no specific performance study is detailed with an associated ground truth. For a CO2 sensor, the "ground truth" for performance testing would typically be accurate measurements from a reference standard gas analyzer.
8. The sample size for the training set
- Cannot be provided. This is not an AI/machine learning device, so the concept of a "training set" in that context does not apply.
9. How the ground truth for the training set was established
- Cannot be provided. See point 8.
Summary of available information regarding performance:
The document states:
- "The TG-901T was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device."
- The device is intended "to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status."
- "The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis."
- It is intended for "patients of ages three (3) years and older."
- "This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute."
Conclusion:
The provided 510(k) summary for the Nihon Kohden TG-901T CO2 Sensor Kit serves the purpose of demonstrating substantial equivalence for regulatory approval. It does not include the type of detailed performance study data, acceptance criteria, sample sizes, or ground truth information typically found for devices requiring a more comprehensive clinical or standalone validation. The focus is on verifying operation and adherence to general safety and performance testing, rather than reporting quantitative performance against specific acceptance metrics.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).