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ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable anatomical areas and for recovery from minor physical injuries.

ComfortCare Absortek fabric construction provides for absorption and venting of perspiration thereby minimizing potential for skin irritation.

ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture and minimizes damp layer conducive to bacterial and fungal growth.

Device Description

(a) Elasticized material to support and compress a part of the body. (b) Insole provides magnetic Magnets encased in breathable fabric reader comers (a) (ents moisture to keep feet dry.

AI/ML Overview

This document describes a Special 510(k) Pre-Market Notification for modifications to an existing device, not a new device requiring a comprehensive performance study with acceptance criteria. Therefore, much of the requested information regarding performance metrics, sample sizes, and expert adjudication for a study proving acceptance criteria will not be present.

Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, despite the addition of magnets.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is largely not applicable in the traditional sense for this type of 510(k) submission. The "acceptance criteria" here relate to the regulatory standards for substantial equivalence, rather than specific performance metrics of the device itself that would require a study to "prove".

The fundamental "acceptance criteria" for this Special 510(k) were to demonstrate that the modifications (adding magnets) did not alter the fundamental technology, safety, or intended use of the predicate devices. The "reported device performance" is the claim of substantial equivalence.

Acceptance Criteria (Regulatory)	Reported Device Performance (Claimed by Med Gen Inc.)
1. Modifications do not alter the intended use of 'compression support and insole products' as identified in Section 880.5075 (Elastic Bandages) and Section 880.6280 (Medical Insoles).	ComfortCare's enhancements (addition of magnets) do not alter the intended use. The intended uses are "relief of minor discomfort that may have resulted from a simple accident, sports-related or intense workplace activities" for compression support, and "provides magnetic magnets encased in breathable fabric...vents moisture to keep feet dry" for insoles, minimizing bacterial/fungal growth. The final "Indications for Use" approved by the FDA aligns with this: "relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable joints and muscles to prevent serious physical injuries." for compression support, and "provide foot comfort while layered absorptive fabric vents perspiration thereby minimizing potential for bacterial and fungal growth" for insoles.
2. The addition of static magnets at present levels of commercial use does not present any history of adverse effects and is within safety limits.	No history of adverse effects reported by the World Health Organization. Numerous studies support safety limits of 20,000 Gauss, determined not to produce detrimental health effects. The letter does not specify the Gauss of the ComfortCare magnets, only that they are "at present levels of commercial use."
3. Modifications do not affect the fundamental technology and science behind similar legally marketed devices. The risk posed by the medical device and reasonable equivalency in technological characteristics are maintained. (This is the core of substantial equivalence for a Special 510(k) for device modification).	Similarities exist in 9 of 11 basic technical characteristics between ComfortCare and legally marketed products. Dominant marketers with magnets (e.g., Homeones, Pinsters) use neoprene for compression, but ComfortCare's non-neoprene elastic fabric without magnet use doesn't differ significantly in properties. The company asserts that the "technology character" is essentially the same as predicates. "ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices." The FDA concurred that the device is "substantially equivalent."
4. Labeling and claims are appropriate and do not make unsupportable structure/function claims or specific indications that deviate from predicate devices' allowed claims for basic compression supports and insoles. Emphasis is on compression/support and perspiration control, with magnets de-emphasized. (This is important when adding a component like a magnet with perceived therapeutic effects).	ComfortCare's packaging makes no structure/function claims, provides no specific indications, and minimally uses magnetic references. The copy emphasis is on 'compression and support' for fitments and 'perspiration control' for insoles. This addresses a potential concern about making unsubstantiated claims related to magnet therapy. The Indications for Use provided and accepted by the FDA align with these claims for support and moisture control, not direct therapeutic claims for magnets.

2. Sample Size Used for the Test Set and the Data Provenance

Not applicable. This submission does not describe a clinical performance study with a test set. The evidence provided is primarily based on regulatory comparison and literature review regarding magnet safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No test set or expert ground truth was established for the device's efficacy in this submission. The FDA's review process inherently involves regulatory experts (e.g., those in the Division of Dental, Infection Control and General Hospital Devices) evaluating the substantial equivalence claim.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was performed.

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. This is not an AI-enabled device or a diagnostic device where MRMC studies would typically be conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established regulatory framework for similar existing devices (predicate devices) and scientific consensus/literature regarding the safety of static magnets.
- For the compression component: Established regulatory classifications (Section 880.5075) for elastic bandages and common use/characteristics of legally marketed products (e.g., Ace, Decam).
- For the insole component: Established regulatory classifications (Section 880.6280) for medical insoles and common use/characteristics of legally marketed products.
- For the magnet component: World Health Organization reports and "numerous studies" supporting the safety limits of 20,000 Gauss, and the historical use of magnets.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would have a "training set." The product's development would likely incorporate design verification and validation testing, but these are not described as "training" in the context of this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this type of device.

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