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OTC Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns. Professional Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Prontosan® Wound Gel is a clear, colorless and virtually odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management that is sterile by aseptic manufacturing until the product is first opened. PHMB is added to the product in the concentration of 0.1% w/w as a preservative to inhibit the growth of microorganisms within the product. Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

The provided text describes a 510(k) submission for the Prontosan® Wound Gel. The submission focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through in-vitro testing for preservative effectiveness and by referencing prior biocompatibility and functional testing. It is not a study about an AI-powered device, medical imaging, or any diagnostic/prognostic tool that would typically involve acceptance criteria for algorithms, human readers, or ground truth establishment as outlined in your request.

Therefore, most of the information requested in your prompt (e.g., acceptance criteria for a device's performance, sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this submission. This document pertains to a medical device (wound gel) and its regulatory clearance process, which relies on demonstrating safety and effectiveness, often through comparison to existing products, rather than validating an algorithm's performance against clinical endpoints or expert interpretations.

Here's a breakdown of why each point is not fully addressable from the given text:

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

   • Not Applicable. The document describes "in-vitro testing conducted to demonstrate the effectiveness of the preservative in Prontosan® Wound Gel and substantial equivalence with predicate device, Anasept® Antimicrobial Skin and Wound Gel." However, specific acceptance criteria (e.g., percentage reduction in microbial growth, specific performance metrics) and detailed results are not provided in this 510(k) summary. The summary concludes that "The non-clinical testing conducted with the proposed device demonstrates that the proposed device is as safe and effective as the predicate device," implying that any set criteria were met.

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

   • Not Applicable. This information is not provided. The testing mentioned is "in-vitro testing" for preservative effectiveness, not a clinical trial or a test of an algorithm on a dataset.

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

   • Not Applicable. There is no "ground truth" in the context of expert interpretation, as this is not a diagnostic device or an AI algorithm relying on human labels. The testing is laboratory-based (in-vitro).

4. Adjudication method for the test set:

   • Not Applicable. No human interpretation or adjudication is 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 is not an AI device, and no MRMC study is mentioned.

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

   • Not Applicable. This is not an algorithm.

7. The type of ground truth used:

   • Not Applicable. The "truth" in this context would be laboratory measurements of preservative effectiveness and material properties, compared against established standards or predicate device performance. Not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/diagnostic device validation.

8. The sample size for the training set:

   • Not Applicable. This is not an AI device, so there is no training set.

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

   • Not Applicable. There is no training set or associated ground truth.

Summary based on the provided text:

The device, Prontosan® Wound Gel, gained 510(k) clearance (K101882) based on demonstrating substantial equivalence to predicate devices (Prontosan® Wound Gel, K090141, and Anasept® Antimicrobial Skin and Wound Gel, K073547). The primary evidence cited for this submission is:

• In-vitro testing conducted to prove the effectiveness of the preservative (0.1% w/w PHMB) in Prontosan® Wound Gel.
• The fact that Prontosan® Wound Gel (K101882) is the same product as in the original Prontosan Wound Gel submission (K090141), with the only difference being expanded indications for use.
• The biocompatibility and functional performance testing conducted on Prontosan Wound Gel in K090141 is considered applicable to K101882.

The conclusion is that this non-clinical testing demonstrates the proposed device is as safe and effective as the predicate device, thereby meeting the requirements for 510(k) clearance for its stated Indications for Use.

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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 , USP , 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 ), bacterial endotoxin (per USP ), 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 Antimicrobial Effectiveness Testing, USP 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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