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The IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "IntraTemp™ Solution Warmer, Model ITW6L." This document establishes that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the manufacturer's 510(k) submission summary, which is a separate document detailing the technical and performance data used to support the substantial equivalence claim.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided FDA letter. The letter is an approval notification, not a technical performance report.

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The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the IntraTemp™ Solution Warmer. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device