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Under the supervision of a healthcare professional, Venus Ag may be used for the management of:

• · wounds with moderate to heavy exudate
• · partial thickness burns
• · leg ulcers, pressure ulcers and diabetic ulcers
• · surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites)
• · traumatic wounds (e.g. abrasions and lacerations)
• wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites.

The product is for a single use only.

Venus Ag 120, 160 and 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber are a soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver. The silver in the wound dressing, when in contact with wound exudate or blood present in wound exudate, has an antimicrobial effect on bacteria held within the dressing, preventing it from being colonized. The absorption of exudate into the dressing forms a gel which assists in maintaining a moist wound environment, supporting autolytic debridement, protects the wound edge and surrounding skin from maceration. Through the gel formation the structure of the dressing remains intact. Debris and any bacteria found in the wound exudate can be retained inside the dressing and removed when the dressing is changed. When dry, Venus Ag can easily be cut to the size of the wound.

The device is a combination product, code FRO.

Venus Ag dressings are supplied in a variety of sizes, configurations, and weights.

The provided text describes the regulatory clearance of a medical device (Venus Ag 120, 160, and 200 Wound Dressing) by the FDA, primarily by establishing substantial equivalence to existing predicate devices. However, it does not contain a typical study design with acceptance criteria for device performance in the sense of a clinical trial or a standalone algorithm-only study for AI/ML devices.

Instead, the document details non-clinical performance testing (bench testing), biocompatibility testing, and a porcine wound healing study to demonstrate that the Venus Ag wound dressing is as safe and effective as its predicate devices.

Here's an attempt to structure the information based on your request, acknowledging that some of the requested fields are not directly applicable to this type of device clearance and the information provided:

Acceptance Criteria and Device Performance

The device's acceptance criteria are framed in terms of meeting established standards (ISO, British Pharmacopoeia, European Standard) and demonstrating equivalence to predicate devices, rather than specific quantitative performance metrics against a clinical outcome.

Table of Acceptance Criteria and Reported Device Performance

Additional Study Information

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document refers to various non-clinical (bench) and biocompatibility tests. For these types of tests, "sample size" refers to the number of samples or specimens tested (e.g., dressings, materials). Specific numerical sample sizes are not explicitly stated in the provided text for each individual test (e.g., "5 samples for absorbency test").
   • The "porcine wound healing study" is an animal study, not human clinical trial. No specific sample size (number of animals or wounds) is provided.
   • Data provenance (country of origin, retrospective/prospective): Not specified in the document. These are non-clinical studies typically conducted in controlled laboratory environments.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • This question is not applicable to the type of studies described. The "ground truth" for non-clinical tests is determined by adherence to established scientific standards, validated test methods, and quantifiable measurements, not expert consensus in the diagnostic sense. For the porcine study, histological analyses would be performed by trained pathologists, but the number and qualifications are not listed.

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

   • This concept of adjudication (often used in clinical image review or complex diagnostic tasks) is not applicable to the non-clinical, bench, and animal studies described for this wound dressing.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive technologies, which this wound dressing is not.

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

   • No, a standalone algorithm-only performance study was not done. This device is a wound dressing, not an AI/ML algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For antimicrobial efficacy: Established microbiological culture methods and count reductions, compared against controls.
   • For silver release, absorbency, tensile strength: Material property measurements obtained through standardized analytical and mechanical testing methods.
   • For biocompatibility: Histological analysis (for implantation and irritation), cytotoxicity assays, pyrogenicity tests, and systemic observation based on ISO 10993 standards.
   • For porcine wound healing study: Histology parameters analyzed to assess the healing process (comparison to predicate and control).
   • For sterilization, packaging, shelf-life: Standardized physical, chemical, and biological indicators and tests to confirm sterility, integrity, and stability within specified limits.

7. The sample size for the training set:

   • This concept of a "training set" is not applicable as this device does not involve AI/ML or a learning algorithm.

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

   • This question is not applicable as there is no "training set" for this device.

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