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ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions.

ROCHAL Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.

ROCHAL Antimicrobial Wound Gel provides a moist environment to wound surfaces. ROCHAL Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial (PHMB). ROCHAL Antimicrobial Wound Gel:

• Resists microbial colonization within the dressing during shelf storage.
• Provides an amorphous gel covering
• Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement where the body's own enzymes breakdown necrotic tissue.

ROCHAL Antimicrobial Wound Gel contains:
Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Octane-1-2-diol, Polyaminopropyl Biguanide (preservative: PHMB 0.1% w/w) Edetate disodium (EDTA), Edetate trisodium (EDTA)

The provided text describes the 510(k) premarket notification for Rochal Antimicrobial Wound Gel, comparing it to a predicate device, Prontosan Wound Gel X (K130857). This submission is for a medical device that is a wound dressing, not an AI/ML medical device. Therefore, the information requested in the prompt regarding acceptance criteria, study data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and effect sizes of human readers with AI assistance is not applicable to this document.

The document discusses performance testing relevant to a wound gel, which includes:

• ISO 10993 Biocompatibility Studies: These studies demonstrate that the device is safe for biological contact.
• Large-Animal, Full-Thickness Wound Healing Study: This study was conducted to demonstrate the safety of the device in a relevant biological model.
• USP Preservative Effectiveness Testing: This confirms the appropriateness of the chosen preservative (Polyaminopropyl Biguanide - PHMB) in the product formulation.
• Real-time Aging Study: This study assesses the stability and performance of the product over its proposed shelf life of six months.

The conclusion drawn is that the Rochal Antimicrobial Wound Gel is substantially equivalent to the predicate device based on similar intended uses, product form, and function, and demonstrated safety and effectiveness through the battery of tests mentioned above.

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Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

Rochal Bioshield Silicone Film is a polymeric solution which forms a protective, polymer film (silicone) when applied to skin. The product is biocompatible and non-stinging. The formed silicone film is colorless, transparent, water-proof barrier, which is breathable, possessing good oxygen and moisture vapor permeability.

Rochal® Bioshield Silicone Film will be supplied in a High-Density Polyethylene (HDPE), 28 mL bottles with pump spray cap.

The provided text describes a 510(k) premarket notification for the Rochal Bioshield Silicone Film. This document is a submission for medical device clearance, not a study report for an AI/ML powered device. Therefore, the information requested about acceptance criteria, specific study design for device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.

The document primarily focuses on demonstrating the substantial equivalence of the Rochal Bioshield Silicone Film to legally marketed predicate devices through comparisons of indications for use, product film appearance, and functions, as well as general performance testing related to biocompatibility and sterility.

Here's a breakdown of what can be extracted and what is missing:

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

The document provides a comparison table between the subject device (Rochal Bioshield Silicone Film), a predicate device (KeriCure Advanced Liquid Bandage), and a reference device (No Sting Barrier Film). While it lists features being compared, it does not outline specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML device.

Reported Performance (General):

• Biocompatibility: Passed ISO 10993 studies (cytotoxicity, sensitization, irritation, pyrogenicity, implantation, chemical analysis, and toxicological risk assessment).
• Sterility: Gamma sterility verified using USP 71, Sterility Tests.
• Shelf life: Real-time aging study indicates the product is stable and effective for the proposed shelf life.

Missing Information (due to the nature of the document):

• Specific quantitative acceptance criteria for each 'feature being compared'.
• Detailed quantitative performance benchmarks or statistical results from the device's operation.

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

This information is not provided in the document. The document refers to "biocompatibility studies" and a "real-time aging study," but no details on sample sizes or data provenance are given for these tests. This is not an AI/ML device, so there is no "test set" in that context.

3. 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 information is not applicable and not provided. The device is a physical product (liquid bandage), not an AI/ML system that requires expert-established ground truth for performance evaluation in the context of diagnostic or prognostic tasks.

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

This information is not applicable and not provided for the same reasons as point 3.

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:

This information is not applicable and not provided. This is not an AI-assisted device, therefore no MRMC study with human readers assisting with AI would have been performed.

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 is not an algorithm or AI system.

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

This information is not applicable and not provided. As a physical product, the "ground truth" for its performance would typically be based on established scientific methods for measuring physical and chemical properties (e.g., film formation, permeability, biological response in specific tests) rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set:

This information is not applicable and not provided. The device is not an AI/ML system that requires a "training set."

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

This information is not applicable and not provided. The device is not an AI/ML system.

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Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin.

Atteris™ Antimicrobial Barrier Film Dressing is a polymeric solution which forms a uniform film when applied to minor wounds and damaged skin. The product is dispersed in a unique non-cytotoxic, non-stinging solution via a standard 28 mL pump spray bottle. The product is biocompatible, non-stinging, fast drying, and has low friction. Antimicrobial Barrier Film Dressing protects minor wounds and damaged skin by providing a secure, breathable, waterproof barrier to external contaminates. The film dressing is colorless, transparent, and possesses good oxygen and moisture vapor permeability. The antimicrobial PHMB at a concentration of 0.001% w/w is added to the product as a preservative to inhibit the growth of microorganisms within the product.

The provided document is a 510(k) premarket notification for the "Atteris Antimicrobial Barrier Film Dressing" and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific acceptance criteria in the context of AI/machine learning performance.

Therefore, most of the requested information regarding AI/ML study design (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Performance Testing" section.

Acceptance Criteria and Reported Device Performance

Answers to other questions based on the provided document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document describes in-vitro lab testing, not a clinical study with a "test set" of patients/data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/ML device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or reference standards for the performance tests were established using recognized international standards and methods, specifically:
   • USP 51 for antimicrobial effectiveness.
   • ISO 10993 parts 1, 5, and 10 for biocompatibility.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a medical device (a film dressing) and its performance is evaluated through standard laboratory and biocompatibility testing, not through AI/ML performance studies.

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(Rx Only) Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.

(OTC use) Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.

Atteris Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. Atteris Antimicrobial Skin & Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The cleanser has a six month expiration due to the preservative that provides bactericidal and fungicidal properties through the action of the antimicrobial (PHMB).

A preservative, PHMB, at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and fungus Candida albicans within the product.

The provided text describes a 510(k) premarket notification for the Atteris™ Antimicrobial Skin & Wound Cleanser. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the document does not contain a study that establishes clinical acceptance criteria for the device's performance in a clinical setting (e.g., wound healing rates, infection reduction rates). Instead, the studies mentioned are to demonstrate the new device is as safe and effective as the predicate based on pre-defined regulatory and biocompatibility standards.

However, I can extract information related to the performance testing that addresses aspects of safety and effectiveness as required for substantial equivalence.

Here's an attempt to organize the information based on your request, focusing on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating equivalence in safety, performance, and specific product characteristics compared to a predicate device, rather than meeting specific clinical efficacy endpoints with numerical benchmarks.

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

• Sample Size: The document does not specify exact sample sizes for the test sets used in the biocompatibility, preservative effectiveness, or shelf-life studies. These would typically be detailed in the full study reports referenced (e.g., Toxikon reports, USP reports), but not in the 510(k) summary. For biocompatibility tests (ISO 10993), sample sizes are generally small (e.g., a few animals or cell cultures per test).
• Data Provenance: The biocompatibility studies were conducted by "Toxikon" (a contract research organization presumably based in the US or an ISO-certified lab). The USP testing is a standard methodology. Real-time aging studies are conducted on the manufacturer's product. The provenance of the data is generally from laboratory testing, which is prospective in nature for these specific tests. Country of origin for data is not explicitly stated but assumed to be from a reputable testing facility.

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

This type of information (experts establishing ground truth for a test set) is not applicable to this 510(k) safety and performance testing. The "ground truth" for these tests are the established standards:

• For biocompatibility: ISO 10993 standards.
• For preservative effectiveness: USP monograph.
  Experts (e.g., toxicologists, microbiologists) would perform and interpret the tests according to these standards, but there isn't a "ground truth" derived from expert consensus on images or clinical outcomes in the context of this submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially those involving human interpretation of data (e.g., radiology reads, pathology diagnoses), to establish a consensus "ground truth." The tests performed here are laboratory-based and follow standardized protocols; outcomes are objective measurements or categorical determinations (e.g., cytotoxic/non-cytotoxic, effective/not effective).

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 a 510(k) clearance for an antimicrobial skin and wound cleanser, not an AI-powered diagnostic or assistive tool. No human readers or AI assistance are involved in the performance evaluation described.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims in this submission are based on:

• Standardized Laboratory Controls: For biocompatibility, the ground truth is whether the device materials elicit a toxic, irritating, or sensitizing response when compared to controls as defined by ISO 10993.
• Pharmacopoeial Standards: For preservative effectiveness, the ground truth is the reduction in microbial count defined by the USP antimicrobial effectiveness test.
• Physical/Chemical Measurements: For shelf life and other characteristics, the ground truth is the stability of physical/chemical properties over time.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a long-lasting waterproof barrier, protecting the skin from bodily wastes, fluids, add friction. It is intended as a primary barrier against irritation from body fluids.

Atteris No Sting Skin Protectant is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. Atteris No Sting Skin Protectant shields intact or damaged skin from irritation caused by bodily fluids, wound drainage, adhesives, and friction. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.

The provided document describes the Atteris No Sting Skin Protectant and its performance characteristics, primarily to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of typical AI/software device evaluation (e.g., diagnostic accuracy on a test set). Instead, it details performance testing to substantiate specific product claims related to its physical and biological properties.

Therefore, many of the requested sections related to AI device evaluation (such as sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to the information contained in this document.

However, I can extract the acceptance criteria (claims) and the reported device performance from the provided text for the aspects that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of inapplicable AI/Software Device Evaluation Criteria:

The following items are not applicable as this document describes a physical medical device (skin protectant) and its chemical/biological properties, not an AI/software device for diagnostic or predictive purposes.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Details of the Studies Conducted (as per the document):

• No Sting:
  • Study: Human testing using the Skin Trauma After Razor Shaving (STARS) bioassay.
  • Purpose: To determine if the protectant caused subjective stinging when applied to skin challenged by dry shaving.
• Barrier Film:
  • Study: Human testing conducted at cyberDERM Clinical Studies.
  • Method: Carbon retention test method.
• Sterile:
  • Study: USP 71, Sterility Tests.
  • Sample Size: 10 test samples.
  • Conditions: After 2 months of accelerated aging.
• Breathable:
  • Study: Oxygen and moisture vapor transmission rate testing.
• Biocompatible:
  • Study: Testing consistent with ISO 10993.
  • Specific Tests:
    • Cytotoxicity: L929 Agar Diffusion Test (Direct Contact); ISO Final GLP Report: 15-04007-G1. Test article: Atteris Skin Protectant on mouse fibroblast L929 cells.
    • Direct Primary Skin Irritation: ISO Final GLP Report: 15-04007-G2. Test article: Atteris Skin Protectant on abraded skin sites of New Zealand White rabbits (single topical minimum 4-hour application).
    • Direct Buehler Sensitization: ISO Final GLP Project: 15-04007-G3. Test article: Atteris Skin Protectant on albino guinea pigs (topical application).
• Dries in ~60 seconds:
  • Study: Human testing conducted at cyberDERM Clinical Studies.
  • Purpose: To determine dry time.
• Good in Skin Folds (non-self-adherent):
  • Study: Human testing conducted at cyberDERM Clinical Studies.
  • Comparison: To the commercial control, 3M Cavilon No Sting Barrier Film.
• Single Patient Use (Use life-28 days after opening):
  • Study: Use life testing.
  • Method: Product opened, sprayed, left open for 28 days, then re-tested to confirm performance characteristics.

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