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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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Prescription Use: Under the supervision of a healthcare professional. Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites; Traumatic wounds. OTC Use: Extra Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns.

Extra Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose (CMC) fibers, strengthening fibers and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment. A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.

This document is an FDA 510(k) summary for a medical device called "Extra Silver Gelling Fiber Dressing". It describes the device and compares it to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for this type of device (wound dressing) typically relies on demonstrating substantial equivalence to a predicate device rather than strict quantitative performance acceptance criteria for clinical efficacy in the same way a diagnostic AI device might. However, it does specify acceptance criteria for non-clinical tests.

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

This document describes non-clinical laboratory testing and equivalence comparisons. It does not involve a "test set" in the context of clinical data for an AI algorithm.

• Sample Size for Test Set: Not applicable in the context of clinical data for AI; non-clinical tests typically use replicate samples of the device itself.
• Data Provenance: Not applicable for clinical data; non-clinical lab tests are performed according to recognized standards.

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

Not applicable. This device is a wound dressing, not an AI diagnostic system requiring expert-established ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. This document pertains to non-clinical testing and substantial equivalence for a physical medical device, not a diagnostic AI system with an adjudication process for a test set.

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-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the specific parameters and methods outlined in the referenced ISO, ASTM, USP, and AATCC standards. For example, for cytotoxicity, the "ground truth" is the observation of cell viability against negative/positive controls as per ISO 10993-5. For antibacterial effectiveness, it's the measured log-reduction of bacterial colonies as per AATCC 100-2012.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

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Under the supervision of a healthcare professional, KerraCel® Ag may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.

KerraCel® Ag is a soft, sterile, nonwoven dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/ cm (1.7 wt/wt%)). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against gram positive and negative bacteria. KerraCel® Ag absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. KerraCel® Ag meets endotoxin limit specifications.

This document is a 510(k) summary for a medical device called KerraCel® Ag Gelling Fiber Silver Dressing. It does not describe an AI medical device. Therefore, much of the requested information regarding AI-specific studies and ground truth methodologies is not applicable.

However, I can extract information related to the device's performance based on the provided text.

Here's a summary of the acceptance criteria (implied by the comparative testing) and reported device performance for KerraCel® Ag, along with other applicable information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in this document. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device (Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing - K080383) and a reference device (Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber - K121275). Therefore, the "acceptance criteria" can be inferred as "comparable to" or "no significant difference from" the predicate and reference devices.

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

• Bench Performance Tests: The sample sizes for each specific bench test (Silver Content, Moisture Content, Absorbency, etc.) are not specified in this document.
• Biocompatibility Testing: The number of samples tested for each biocompatibility test (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation) is not specified.
• Porcine Wound Healing Study:
  • Sample Size: Six pigs were involved, with eight 2x2 cm full-thickness wounds created per animal (totaling 48 wounds).
  • Data Provenance: The study was a "Pre-Clinical Study" conducted on porcine models. The country of origin is not explicitly stated. The study design is prospective as it involves active treatment and follow-up.

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

Given this is a 510(k) for a wound dressing, not an AI device, there were no "experts" establishing ground truth in the context of diagnostic interpretation.

• In the porcine wound healing study, the evaluation included "Histopathology evaluation." This would typically involve veterinary pathologists. Their specific number and qualifications are not stated.

4. Adjudication Method for the Test Set

Not applicable for device performance and animal studies in this context. Adjudication methods are typically relevant for human clinical trials or expert review of diagnostic results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is not an AI medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

• Bench Performance Tests: The "ground truth" for these tests would be the measured physical and chemical properties themselves, using standardized testing methods.
• Biocompatibility Testing: The "ground truth" is established through adherence to recognized international standards (e.g., ISO 10993-1:2009 for biocompatibility) and the specific endpoint measurements of each test (e.g., cytotoxicity assays, irritation scores).
• Porcine Wound Healing Study:
  • Clinical Findings: Direct observation of the wounds by study personnel.
  • Planimetric Analysis: Measurement of wound area.
  • Histopathology Evaluation: Microscopic examination of tissue samples by trained pathologists, providing a "ground truth" on tissue response and healing at a cellular level.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable.

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