RECOVER ADULT VEIN WARMER

• K Number: K963689
• Device Name: RECOVER ADULT VEIN WARMER
• Manufacturer: FLORIDA MEDICAL INDUSTRIES, INC.
• Date Cleared: 1996-12-12 ( 87 days)
• Product Code: IMD
• Regulation Number: 890.5710
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

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

AI/ML Overview

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.

Regulation Number and Section

§ 890.5710 Hot or cold disposable pack.

(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.