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OTC: Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from minor sunburn. Professional Use: Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and painrelief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microcyn Skin and Wound HydroGel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.

Microcyn™ Skin and Wound HydroGel is a clear viscous, odoriess, aqueous hydrogel. The gel will be supplied in 2 oz polyethylene terephthalate bottles with polypropylene, tamper resistant caps as described in Section 11.3.

This looks like a 510(k) premarket notification for a medical device called Microcyn™ Skin and Wound HydroGel. This document is a submission to the FDA (Food and Drug Administration) to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a full Premarket Approval (PMA) process.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

This document describes a medical device (Microcyn™ Skin and Wound HydroGel) seeking 510(k) clearance, which is a process to demonstrate substantial equivalence to a predicate device. It is not a study that establishes acceptance criteria and proves performance in the way clinical trials for new drugs or more complex devices might. Instead, the "acceptance criteria" here are implicitly tied to the safety and functionality demonstrated by the predicate device and the general requirements for such wound dressings.

Here's the breakdown based on the information provided, recognizing the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a wound hydrogel, the "acceptance criteria" are primarily related to safety, biocompatibility, and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity or specificity for an AI-powered diagnostic. The device's performance is demonstrated through in-vitro and in-vivo testing to show it is safe and functions as intended.

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

This document does not specify a "test set" in the context of a dataset for an AI algorithm. The testing described relates to biological and chemical properties of the hydrogel.

• Sample Size: Not specified for biocompatibility or other performance tests (e.g., how many animals were used, how many samples for in-vitro tests). It mentions "two species of animal" for sensitization testing, but not the number of animals per species.
• Data Provenance: The tests are in-vitro (lab-based) and in-vivo (animal studies, "two species of animal"). There is mention of "Clinical experience with the solution form of the product indicates the Microcyn™ Skin and Wound HydroGel is safe for its intended use," which suggests some human data exists for a previous version or related product, but no details are provided about this "clinical experience" for the hydrogel specifically. The focus for this 510(k) is heavily on bench and animal testing.

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

Not applicable in this context. This is a medical device (hydrogel), not an AI diagnostic algorithm that requires expert-established ground truth on a test set of images or patient data. The "ground truth" for these tests would be the established scientific methods and pass/fail criteria for biocompatibility, antimicrobial effectiveness, etc.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" of expert opinions for a test set in the context of evaluating a wound hydrogel's physical and biological properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging-based AI) to compare human reader performance with and without AI assistance. This document is for a wound dressing, which has a different evaluation paradigm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

No, this is not an AI algorithm. It's a wound hydrogel.

7. The Type of Ground Truth Used

The "ground truth" is established through:

• Standardized Biocompatibility Testing: According to ISO 10993 (cytotoxicity, sensitization).
• Standardized Antimicrobial Testing: USP Antimicrobial Effectiveness Testing .
• Bench Testing: To confirm properties like moisture absorption, exudate control, and physical characteristics.
• Animal Testing: For dermal irritation and sensitization in "two species of animal."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in this submission.

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

Not applicable. As above, there is no training set for an AI algorithm.

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