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ComfortCare Compression Support with Magnets & Anti-Bacterial Agent is designed to provide relief of minor physical discomforts that have their origin in strenuous or intense physical activities associated with athletic, workplace and at-home activities. Device provides support for relief of minor physical discomforts and at-home activities. Device provides support for relief of discomfort in self-limiting physical injuries.

ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in compressed areas, minimizing potential for skin irritation.

ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered absorptive fabric vents moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.

(a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew

The provided document is a 510(k) summary for a medical device modification, specifically for "ComfortCare Compression Support with Magnets & Anti-Bacterial Agent" and "ComfortCare Magnetic Insoles with Anti-Bacterial Agent." The document does not contain acceptance criteria or a study that establishes device performance against such, in the way one would expect for a performance study.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their modified device is as safe and effective as existing legally marketed devices, rather than presenting novel performance data.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, ground truth establishment, sample sizes for test and training sets, MRMC studies) are not applicable or cannot be extracted from this particular type of regulatory submission. The document explicitly states: "In the absence of a classification ruling, Med Gen Inc. has referenced similar compression support products and insoles as comparative bases for substantial equivalence." and "ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices."

However, I can extract the information that is present and explain why other information is absent based on the nature of a 510(k) substantial equivalence submission.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense for a performance study. The "acceptance criteria" for a 510(k) submission of this type are based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially the manufacturer's assertion that the modifications (addition of magnets and anti-bacterial agents) do not alter the fundamental intended use, safety, or effectiveness compared to the predicate devices.

The document states:

• "Similarities exist in 9 of 12 basic technical characteristics between ComfortCare and legally marketed products."
• "The intended use, technical and safety attributes with or without magnets are essentially the same as ComfortCare products."
• "ComfortCare's enhancements do not alter the intended use of 'compression support and insole products'..."
• "ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices."

2. Sample size used for the test set and the data provenance

Not applicable. This document does not describe a performance study with a test set. The submission relies on a comparison of characteristics to existing legally marketed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or expert adjudication is described.

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 device is a physical medical device (compression support and insoles), not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or performed.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The ground truth for this type of submission is the established safety and effectiveness of the predicate devices to which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning or AI device that would require training data.

9. How the ground truth for the training set was established

Not applicable. This document does not describe a machine learning or AI device.

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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.

(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.

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.

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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