Search Results

The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.

Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.

This 510(k) summary describes a medical device, the Recover® Infant Heel Warmer, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about clinical performance, ground truth, or expert involvement as requested in your prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document provided focuses on the physical description, contents, temperature, and intended use of the device, along with its classification and predicate device. It's a pre-market notification (510(k)) summary from 1997, which might predate the regulatory requirements for the types of detailed performance studies you are asking about, especially those related to AI/algorithm performance.

Ask a specific question about this device