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OTC Indications: Hychloderm Wound and Skin Care (OTC) is intended for over-the-counter use in the management of minor irritations, minor abrasions, minor burns, minor lacerations, and intact skin and lubrication absorbent wound dressings.

Rx-only Indications: Hychloderm Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor abrasions, minor lacerations, cleansing, irrigating, and debriding to remove wound debris from acute and chronic dermal or full thickness wound such as, stage I-IV pressure ulcers, diabetic foot ulcers, lst and 2nd degree burns, post-surgical wounds, and lubricating absorbent wound dressings.

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are a single-patient single-use. clear liguid solution containing 0.01% hypochlorous acid (HOCI) as preservative in water/saline buffer, that aids the mechanical removal of debris and foreign material from the application site. Dirt, debris and foreign material is mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). lt can be used in all stages of wound care and it is an ideal foundation for wound bed preparation. In addition to moistening and lubricating adsorbent wound dressings. It is a clear solution with 0.01% of hypochlorous acid that has been demonstrated to act as a preservative that inhibits microbial contamination within the solution.

The provided text describes the marketing authorization for "Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)" through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with established acceptance criteria. Therefore, the information typically required to answer your prompt, such as detailed acceptance criteria tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document.

The document primarily focuses on:

• Device Description: What the product is (a clear liquid solution with 0.01% hypochlorous acid).
• Intended Use/Indications for Use: For OTC and Rx applications related to wound and skin care (e.g., minor irritations, abrasions, burns, lacerations, cleansing wounds).
• Substantial Equivalence: The core argument for FDA clearance, comparing Hychloderm to previously cleared predicate devices (e.g., Puracyn Plus™, Vashe® Wound Therapy Solution).
• Performance Testing: It mentions bench, biocompatibility, and animal testing and preservative effectiveness tests (USP) were performed to support safety and intended function, and that the product is biocompatible and non-toxic.

Summary of missing information:

• Acceptance Criteria Table and Reported Device Performance: This document does not establish specific performance metrics or acceptance criteria for the device beyond demonstrating substantial equivalence and meeting general safety assessments like biocompatibility and preservative effectiveness. Performance is implicitly considered "acceptable" if it is equivalent to the predicate devices and passes general safety tests.
• Sample Size and Data Provenance: Not applicable in the context of a 510(k) submission based on substantial equivalence, especially one relying on bench, biocompatibility, and animal testing. There's no "test set" of patient data in the sense of a clinical performance study.
• Number of Experts and Qualifications: Not relevant for this type of submission. Ground truth, if any, for in vitro or animal studies would be defined by standard laboratory protocols rather than expert consensus on medical images or clinical outcomes.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Study: Not applicable. This is for AI/imaging devices, which Hychloderm is not.
• Standalone Performance: While the document states "All of the testing showed that the product functions as intended," it doesn't provide specific standalone performance data (e.g., efficacy rates on wound healing) in a rigorous clinical trial context. The focus is on function as a wound cleanser and preservative effectiveness.
• Type of Ground Truth: The "ground truth" here is based on laboratory standards (e.g., USP for preservative effectiveness, ISO 10993 for biocompatibility) and comparison to predicate devices, rather than clinical outcomes or physician consensus on patient data.
• Sample Size for Training Set & Ground Truth for Training Set: This is a medical device, not an AI/ML model that requires training data in the computational sense. The "training" for such a device would involve its formulation and manufacturing process, and data for this is not specified as a "training set."

In conclusion, based on the provided text, it is not possible to describe the acceptance criteria and study as if it were an AI/imaging device or a device that underwent a comparative clinical efficacy trial. The document is a 510(k) clearance letter, which relies on demonstrating substantial equivalence and general safety/performance through non-clinical testing.

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