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Prontosan™ Wound Gel is intended for moistening and cleansing wounds by maceration of wound coatings and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds, and abrasions.

Prontosan™ Wound Gel is a clear, colourless liquid-gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan™ Wound Gel is used for managing and treating wounds by sustaining wound moisture between dressing changes and aiding in the manual removal of wound exudates and encrustations. The gel is aseptically filled using a blow fill seal process into low density polyethylene 30 mL squeeze bottles with screw caps.

This document is a 510(k) premarket notification for a medical device (Prontosan™ Wound Gel) and does not describe acceptance criteria or a study that rigorously tests the device against such criteria in the way a clinical performance study for an AI/ML device would. Instead, it demonstrates substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety testing.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not applicable to this submission.

However, I can extract the relevant information regarding the stated safety and performance support for the device:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on the "Reported Performance": The document states that these tests were "supported by" or "conducted with" Prontosan™ Wound Gel, implying successful completion and meeting of relevant standards to demonstrate safety and effectiveness.

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

• Not applicable. This submission relies on substantial equivalence to a predicate device and direct safety testing, not a clinical "test set" in the context of an AI/ML or diagnostic performance study.
• The provenance for the safety tests (biocompatibility, USP <51>, USP <85>, shelf life) is the product itself, as tested by the manufacturer.

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

• Not applicable. Ground truth in the context of expert review for a test set is not relevant to this type of device submission. The "ground truth" for safety aspects would be established by the respective test methodologies and their validated standards.

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

• Not applicable. There was no "test set" and no expert adjudication process 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 wound gel, not an AI/ML-powered diagnostic or assistive tool.

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

• Not applicable. This device is a wound gel, not an algorithm.

7. The type of ground truth used:

• For safety: The "ground truth" was established by the outcomes of standard, validated laboratory tests for biocompatibility, antimicrobial effectiveness (per USP <51>), bacterial endotoxin (per USP <85>), and product shelf life. These are objective measures with established pass/fail criteria.
• For effectiveness/performance: The "ground truth" for effectiveness is primarily established by substantial equivalence to the predicate device, Prontosan™ Wound Irrigation Solution, which implies similar clinical utility for wound moistening and cleansing based on its known formulation and the presence of minor inactive ingredients (hydroxyethylcellulose and glycerol) that add viscosity and moisturizing properties. No new clinical performance studies proving efficacy were presented, as per the 510(k) pathway.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. Since there is no training set, this question is not relevant.

Summary of Device Substantiation:

The B. Braun Medical, Inc. Prontosan™ Wound Gel received 510(k) clearance based on demonstrating substantial equivalence to a legally marketed predicate device (Prontosan™ Wound Irrigation Solution). The primary evidence for this was:

• Similar Intended Use: Both devices are for moistening and cleansing wounds.
• Similar Technological Characteristics: The core active ingredients and mechanism of action are similar. The gel formulation adds inactive ingredients (hydroxyethylcellulose and glycerol) for viscosity and moisturizing, which are described as not raising new questions of safety or effectiveness.
• Safety Testing: Biocompatibility testing, USP <51> Antimicrobial Effectiveness Testing, USP <85> Bacterial Endotoxin Testing, and shelf life testing were conducted to demonstrate the safety of the specific gel formulation. The document states these tests "supported" the safety and effectiveness, implying acceptable results.

The 510(k) pathway (especially for Class II devices without special controls or Class I unclassified devices like this one) does not typically require extensive clinical trials or performance studies that would utilize concepts like "acceptance criteria" against clinical performance metrics, expert adjudication, MRMC studies, or AI training/test sets. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

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