Search Results

MendaSil™-TWG Gel Skin and Wound Gel is indicated for use under the supervision of a healthcare professional for management of partial to full thickness wounds from mild to moderate exudate such as Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Venous Stasis Ulcers and Surgical Incision Wounds. The Gel can also be used for management of minor cuts, scrapes/abrasions, and irritated skin.

MendaSil™ TWG Skin and Wound Gel is an amorphous wound moisture management gel that helps maintain a moist wound environment that is conducive to healing by either absorbing the wound exudates or donating the moisture. The Gel contains a silver compound that is an effective barrier to bacterial penetration by inhibiting the growth of a broad spectrum of microorganisms which come into contact with the gel. MendaSil™-TWG Skin and Wound Gel will be supplied in conventional HDPE bottles fitted with a "flip top" dispenser closure. This bottle will be placed in a chipboard dispenser box with a package insert.

The provided text describes a 510(k) summary for a medical device called MendaSil™ TWG Skin and Wound Gel. It focuses on demonstrating substantial equivalence to predicate devices rather than fully detailing a standalone study with acceptance criteria and performance metrics in the way a clinical trial for a novel AI diagnostic device would.

However, I can extract the relevant information and present it in the requested format, interpreting "acceptance criteria" from the context of what the device needs to prove to be considered substantially equivalent and effective.

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance for MendaSil™ TWG Skin and Wound Gel

This document describes a 510(k) submission for MendaSil™ TWG Skin and Wound Gel, which aims to demonstrate substantial equivalence to legally marketed predicate devices. The acceptance criteria are implicitly derived from the common performance characteristics and safety profiles of such devices, as well as specific tests conducted to show the properties of the new device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for a wound gel, the "acceptance criteria" are not quantitative thresholds like sensitivity/specificity for a diagnostic AI. Instead, they relate to:

• Maintaining a moist wound environment: A primary function of hydrogel dressings.
• Antimicrobial efficacy: The silver compound's ability to inhibit bacterial growth.
• Biocompatibility: Showing the material is safe for human contact.
• Manufacturing quality: Adherence to GMP.
• Substantial equivalence: Demonstrating similar technological characteristics and intended use to predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of human clinical data. The performance testing involves laboratory-based tests.
  • For USP Preservative Efficacy and Kirby Bauer Zone Inhibition Testing: These tests typically use standardized microbial cultures (test organisms and additional bacterial strains). The exact number of strains or replicates is not specified but follows USP guidelines.
  • For Biocompatibility (Cytotoxicity, Sensitization, Irritation): These are typically in vitro or in vivo (animal) studies, not human clinical trials for a 510(k). The exact sample size (e.g., number of cell cultures, number of animals) is not provided in this summary.
• Data Provenance: The data comes from laboratory testing. The country of origin for the studies is not specified, but the submission is to the US FDA. The information is prospective in the sense that these tests were performed specifically for this 510(k) submission, not gathered retrospectively from existing 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 to this type of submission. "Ground truth" established by experts (like radiologists for imaging devices) is typically relevant for diagnostic devices, especially those involving human interpretation. For a wound gel, the "ground truth" is established by laboratory methods based on scientific principles (e.g., microbial inhibition zones, cell viability assays). The experts involved would be laboratory scientists and toxicologists interpreting these test results.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple human readers in clinical studies, particularly for diagnostic accuracy. Since the performance testing here is laboratory-based, this concept does not apply.

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 submission is for a material-based medical device (wound gel), not an AI algorithm or a diagnostic device involving human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable. This is not an AI algorithm. The performance testing mentioned (antimicrobial efficacy, biocompatibility) are "standalone" in the sense that they assess the device's intrinsic properties in a controlled laboratory environment. They are not assessing an algorithm's performance.

7. The type of ground truth used

• The "ground truth" for the performance claims typically relies on:
  • Validated laboratory assay results: For antimicrobial activity (Kirby Bauer, USP Preservative Efficacy) and biocompatibility (cytotoxicity, sensitization). These assays have established endpoints and interpretative criteria.
  • Established scientific principles: For evaluating the physical property of maintaining a moist wound environment, which is a known characteristic of hydrogels.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI models that require a "training set."

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

• Not applicable. No training set is involved.

Ask a specific question about this device