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The Medical Products, Inc. (MPI) Tempo III warmer is designed to store and warm I.V. fluid bags/boctles prior to their use.

Tempo III warmer

This FDA 510(k) letter for the Tempo III Infusion Pump does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot extract the requested information from the provided text.

Specifically, the letter states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was found to be "substantially equivalent" to an already approved device, rather than undergoing a new, independent performance study with defined acceptance criteria.

The letter discusses regulatory requirements, contact information, and the device's intended use (an I.V. fluid warmer), but it does not provide:

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

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