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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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Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, which are:

• · Moderately and heavily exuding
• · Superficial or
• · Deep
  Such as:
• Pressure sores
• Arterial Ulcers
• · Venous lower leg ulcers
• · Diabetic ulcers
• · Post-operative wounds

Suprasorb® A + Ag "R" is a calcium alginate dressing with antibacterial silver. This device is a minor modification of the predicate device in which regenerated cellulose fibers (Tencel®) for strengthening purposes has been added. The dressings are also made in 2 variants namely 120 gsm and 200 gsm (in line with customer requirements for various options when choosing suitable size dressing for a wound) and are soft, conformable wound covers with a high mannuronic acid content. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 5 days in the in vitro challenge test. The Suprasorb® A + Ag "R" Calcium Alginate Dressings with antibacterial silver (reinforced variant) are sterilized by irradiation and must not be re-sterilized. The product remains sterile unless the package is opened or damaged. Single use only should be applied and the product is for prescription use only.

The provided text describes a medical device, Suprasorb A + Ag "R", a calcium alginate dressing with antibacterial silver, and its substantial equivalence to a predicate device, Suprasorb A + Ag (K071442). The document focuses on demonstrating that the modified device, despite adding regenerated cellulose fibers for strengthening, maintains equivalent safety and performance.

However, the document does not describe a study that uses acceptance criteria in the context of a diagnostic or AI-driven device's performance metrics like sensitivity, specificity, or AUC, or human reader performance. Instead, the "acceptance criteria" discussed are related to the biological and physical properties of a wound dressing, which are verified through various physical and chemical tests.

Therefore, many of the specific points requested in the prompt related to acceptance criteria for device performance (e.g., sensitivity, specificity), sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable or
available from this document.

Below, I will present the information that is present in the document, framed as closely as possible to your request, and explicitly state what information is not available.

Acceptance Criteria and Device Performance for Suprasorb A + Ag "R"

The acceptance criteria and reported device performance are based on the comparison of the subject device (Suprasorb A + Ag "R") to its predicate device (Suprasorb A + Ag, K071442). The "performance" in this context refers to the physical, chemical, and biological properties of the wound dressing, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This information is not provided in the document in terms of specific numbers of samples for each test (e.g., how many dressings were tested for silver release or tensile strength). The document generally refers to "testing" that was conducted.
• Data Provenance: The tests are conducted according to international standards (e.g., ISO, ASTM, British Pharmacopoeia, AATCC), implying laboratory-based testing rather than clinical study data from a specific country or retrospective/prospective design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not applicable and not provided. The "ground truth" for the device's physical and biological properties is established by the results of standardized tests against defined criteria. There is no mention of human expert consensus or clinical adjudication for these types of performance evaluations.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. Adjudication is typically associated with human interpretation of medical data, which is not what is being evaluated here. The device's performance is measured against objective laboratory test standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• This information is not applicable and not provided. This document describes a wound dressing, which is a medical device, not an AI or diagnostic tool that involves human readers interpreting medical images. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.

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

• This information is not applicable and not provided. This device is a wound dressing, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective measurements from laboratory tests conducted according to recognized international and pharmacopoeia standards (e.g., AATCC 100 for antibacterial activity, British Pharmacopoeia for absorbency and wet tensile strength, ISO 10993 for biocompatibility, ISO 11137 for sterilization, ASTM for packaging). These standards themselves define what constitutes acceptable performance for each characteristic.

8. The Sample Size for the Training Set

• This information is not applicable and not provided. This product is a physical medical device (wound dressing), not a software algorithm that requires a training set. The "training" for such a device involves manufacturing processes and quality control, not data training.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable and not provided for the reasons mentioned in point 8.

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