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Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.

OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.

PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The-Counter use.

The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.

The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%).

The provided text is a 510(k) Summary for the PuriCore Wound Hydrogel Spray Dressing. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove performance against specific clinical efficacy metrics for a novel medical device. The document explicitly states "Non clinical product testing has proven that Puricore Wound Hydrogel Spray Dressing is substantially equivalent to the predicate devices".

Therefore, based solely on the provided text, I cannot extract information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for a new device's clinical performance. The document describes pre-clinical testing for biocompatibility and shelf-life related attributes, which are important for safety and product stability, but not directly about clinical efficacy or specific functional performance criteria in a wound healing context beyond what the predicate devices are already cleared for.

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

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

Since this 510(k) is about demonstrating substantial equivalence to existing predicate devices, the "acceptance criteria" are primarily that the PuriCore Wound Hydrogel Spray Dressing is as safe and effective as the predicates. The reported device performance is largely a confirmation of this equivalence through various non-clinical tests.

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

• Sample Size for Test Set: Not specified. The document mentions "biocompatibility studies" and "Preservative Effectiveness testing" but does not detail the number of samples or subjects used for these specific tests.
• Data Provenance: The tests are "Pre-Clinical Testing." No country of origin is mentioned for the data itself, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.

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

• Not applicable as this is a pre-clinical, non-human study for substantial equivalence rather than a clinical trial requiring expert consensus on outcomes. The "ground truth" for these tests would be established by the standardized methods and criteria of the specific ISO standards (e.g., ISO-10993-1 for biocompatibility) and other test protocols.

4. Adjudication method for the test set:

• Not applicable for the reported pre-clinical testing. Adjudication methods are typically relevant for human clinical trials or image interpretation studies where multiple expert opinions need to be reconciled.

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-assisted device, nor does the document describe an MRMC study.

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-based device.

7. The type of ground truth used:

• For the pre-clinical tests (biocompatibility, chemical stability, etc.), the "ground truth" is defined by the objective results against established scientific and regulatory standards/protocols (e.g., ISO-10993-1, USP preservative effectiveness tests).

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set. The term "training set" refers to data used to train machine learning models.

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

• Not applicable. (See #8)

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