(70 days)
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.
§ 880.5075 Elastic bandage.
(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.