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The TED 60T is intended to accurately measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and neonatal care. The TED 60T is intended for use only as a secondary measuring device to verify and spot check the concentration of oxygen in gas mixtures. The TED 60T should not be used as a primary monitoring device.

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I apologize, but the provided text from the FDA 510(k) premarket notification for the TED 60T Oxygen Analyzer does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a letter from the FDA to the manufacturer, acknowledging the 510(k) submission and stating that the device is substantially equivalent to a legally marketed predicate device. It permits the manufacturer to market the device subject to general controls.

Specifically, the document lacks the following information:

1. A table of acceptance criteria and the reported device performance: This is not present. The letter mentions that the device is intended to "accurately measure and display the concentration of oxygen," but no specific performance metrics or acceptance criteria are provided.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth... and their qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more typically associated with imaging-based AI devices, not a physical sensor like an oxygen analyzer.
6. Standalone performance: While the device is standalone in terms of its function (an oxygen analyzer), no performance study of its standalone capabilities against specific criteria is detailed.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned. Oxygen analyzers are typically hardware devices; discussions of "training sets" are more relevant to software-based or AI/ML devices.
9. How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on the regulatory approval and the device's intended use. It does not delve into the specific technical studies or performance data that would have been submitted as part of the 510(k) application itself.

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