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Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus Antimicrobial Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications for Use: Microcyn Plus Antimicrobial™ Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

The Microcyn Plus Antimicrobial Wound Care Solution is a clear hypotonic solution that aids in the mechanical removal of debris and foreign material from the application site. It is also for the management of skin abrasions, lacerations, irritation, cuts, and wounds. The solution is supplied in glass bottles with lined caps with a pH range of 3.5 - 6.0. Ingredients: water, sodium chloride, hypochlorous acid.

The provided text describes a 510(k) summary for the Microcyn Plus Antimicrobial Wound Care Solution, which evaluates its substantial equivalence to predicate devices. This type of submission relies on demonstrating similarity to already legally marketed devices rather than conducting a full clinical study to prove efficacy, especially for Class I or II devices where such extensive studies might not be required.

Therefore, the information regarding acceptance criteria and performance is focused on bench testing and biocompatibility to prove the device's similarity and safety, rather than a clinical trial with human subjects, AI performance metrics, or complex ground truth establishment.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the way one might expect for an AI/diagnostic device. Instead, the performance data provided are primarily for bench testing to ensure the new device functions similarly to the predicate devices and meets safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable or not provided in the context of this 510(k) summary. The testing described is laboratory-based bench testing and biocompatibility assessments, not a clinical trial with a "test set" of patient data.

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

This information is not applicable or not provided. Since there isn't a "test set" of clinical data requiring expert review for ground truth, this aspect is not part of the submission. The ground truth for chemical and physical properties comes from established scientific methods and readings.

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

This information is not applicable or not provided. There is no clinical test set requiring adjudication.

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

This information is not applicable. The device is a wound care solution, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to this submission.

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

This information is not applicable. The device is not an algorithm or AI.

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

The "ground truth" for the tests performed is based on established laboratory standards, chemical analysis, and microbiological testing methodologies. For example:

• Biocompatibility: Adherence to ISO standards and FDA guidelines.
• pH, Osmolality, FAC: Instrumental measurements against known chemical standards.
• Preservative Effectiveness: Standardized microbiological challenge tests (USP ) against recognized microbial strains.

8. The sample size for the training set

This information is not applicable or not provided. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The development and formulation of the solution would involve iterative testing, but not in the sense of a machine learning training set size.

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

This information is not applicable or not provided. As above, there is no "training set" for an AI algorithm. The development of the solution would rely on scientific principles and established chemical and biological testing methods for quality control and formulation, rather than a labeled "ground truth" for training an algorithm.

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