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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.

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The Recover® Instant Heat Therapy Pack is intended for use with conditions that indicate the use of heat therapy.

Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon bag. Provides heat to 112ºF.

The provided text is a 510(k) summary for a medical device (Recover® Instant Heat Therapy Pack). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria, study details, device performance, ground truth, or sample sizes related to AI/algorithm performance.

Therefore, I cannot fulfill the request using the provided input. The request asks for details typically found in studies evaluating artificial intelligence or machine learning models, which are not present in this document.

Here's why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document only provides a comparison of features (solution, disc, temperature) with a predicate device, not performance metrics against acceptance criteria.
2. Sample size used for the test set and the data provenance: No test set is mentioned, as this is not an AI/algorithm evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is irrelevant for this type of device submission.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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