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Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow

Astotherm Plus, Astotubes, Astoline

I am sorry, but the provided text from the FDA 510(k) notification for the "Astotherm Plus, Astotubes, Astoline" devices does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is a general clearance letter stating that the device is "substantially equivalent" to previously marketed devices and lists its "Indications for Use." It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in detailed premarket submission documents, clinical trial reports, or performance testing summaries, which are not present in this specific clearance letter.

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