(196 days)
The Nihon Kohden TG-920P 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 (end tidal CO>) status. As interpreted by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.
The TG-920P 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 (end tidal CO>) status. The device measuring technique is through absorption of infrared radiation. The mouth/nose piece airway adapter, is a Single-Patient-Use and hence, disposable. The device is intended as an indicator of patient carbon dioxide concentration during expiration, for non-intubated patients.
The provided text does not contain detailed information about specific acceptance criteria and the study that proves the device meets them for the TG-920P CO2 Sensor Kit. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
However, based on the text, I can extract and infer some general information related to device performance and testing:
1. A table of acceptance criteria and the reported device performance:
The document states: "The device performance and specifications are consistent with all requirements for this device type." However, it does not provide a table of precise acceptance criteria (e.g., accuracy, precision ranges) or specific numerical performance results. It only broadly states compliance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in detail, but expected to be in line with gas analyzer performance characteristics) | "The device performance and specifications are consistent with all requirements for this device type." |
| Electromagnetic compatibility | Device was subject to electromagnetic testing. |
| Environmental stability | Device was subject to environmental testing. |
| Safety | Device was subject to safety testing. |
| Performance | Device was subject to performance testing. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document only mentions "performance testing procedures" without detailing the number of cases or samples.
- Data provenance: Not specified. It's unclear if testing involved human subjects, simulated data, or a combination, nor is the country of origin mentioned.
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 document does not describe the establishment of a "ground truth" using experts for the performance testing.
4. Adjudication method for the test set:
Not specified. No details are provided regarding any adjudication methods used for performance testing.
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:
- MRMC study: Not applicable and not mentioned. This device is a CO2 sensor kit, not an AI-powered diagnostic imaging tool that would typically involve human "readers" or AI assistance in interpretation.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: The entire device, as a sensor, operates in a "standalone" fashion in terms of its measurement function. Its stated intended use is "to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory (end tidal CO2) status." The performance testing mentioned would implicitly be evaluating this standalone measurement capability. However, the document doesn't explicitly frame it as an "algorithm only" study in the context of AI.
7. The type of ground truth used:
The type of ground truth for the "performance testing" is not explicitly stated. For a CO2 sensor, the ground truth would typically be established by a highly accurate reference method or calibrated gas mixtures. The document only mentions "performance testing procedures."
8. The sample size for the training set:
- Training set: Not applicable and not mentioned. This device is a sensor, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable, as there is no training set for this type of device.
In summary:
The provided 510(k) summary is focused on demonstrating substantial equivalence, meaning it relies on the predicate device's established safety and effectiveness. It confirms that the new device underwent standard safety and performance testing for its type, but it does not provide the detailed scientific study results, specific acceptance criteria values, or methodologies typical of AI/software device submissions.
§ 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).