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The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.

The CMB Antimicrobial dressing is a single layer dressing consisting of a woven adsorbent polyester containing elemental silver and zinc. In the presence of exudate, the dressing can be used with an appropriate secondary barrier to help maintain a moist wound healing environment.

The provided text describes the CMB Antimicrobial Dressing, a device primarily for wound care. There is very limited information about specific acceptance criteria or details of a study that proves the device meets particular criteria. The document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a novel device.

However, based on the limited information provided, here's an attempt to answer your questions:

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

The document does not explicitly state numerical acceptance criteria with corresponding performance results. It only mentions types of tests performed.

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

The document does not specify sample sizes for any of the in vitro or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 is not applicable to the information provided. The studies mentioned (antimicrobial performance, biocompatibility) are laboratory tests, not clinical studies requiring expert interpretation of results to establish a "ground truth" in the way it's described for image analysis or diagnoses.

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

Not applicable. Laboratory tests typically involve established protocols and readouts, not adjudications of subjective interpretations.

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

No such study was mentioned. The device is a wound dressing, not an AI-powered diagnostic tool that human readers would use.

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

This question is not applicable as the device is a physical wound dressing, not an algorithm. The "antimicrobial performance" was tested in vitro, which can be considered a standalone test for the device's inherent property.

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

For the in vitro antimicrobial performance, the ground truth would be established by standard microbiological methods, such as colony counts or zone of inhibition measurements, which quantify bacterial reduction or inhibition. For biocompatibility tests, the ground truth is established by standard toxicology and biological evaluation methods (e.g., cell viability assays for cytotoxicity, skin reaction scores for irritation/sensitization). These are objective measurements against established scientific standards, not expert consensus or pathology in the clinical sense.

8. The sample size for the training set

Not applicable. The CMB Antimicrobial Dressing 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, as there is no training set for this type of device.

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Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.

Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination.

The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".

This premarket notification (K050086) for Brennen Medical, Inc.'s Silver Glucan Wound Dressing does not contain detailed acceptance criteria or a dedicated study report proving the device meets specific performance metrics in the way modern medical device submissions typically do for AI/ML devices.

Instead, this 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use, and presents a list of general performance tests conducted. The "acceptance criteria" here are implied by the successful completion of these tests and the determination of substantial equivalence (rather than specific quantitative thresholds).

Therefore, I will extract the information available and note where specific details are not provided in this document format.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative thresholds for "acceptance criteria" (e.g., minimum tensile strength in Newtons, specific cytotoxicity scores, exact zone of inhibition measurements) are not detailed in this summary. The summary broadly states that the device "is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."

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

This 510(k) summary does not describe specific "test sets" in the context of an algorithm or AI model evaluation. The "studies" mentioned (Biocompatability, Animal Wound Healing, Silver Dissolution, Tensile Strength, Barrier Efficacy, Zone of Inhibition, Stability) are laboratory or animal-based performance tests, not clinical evaluations with human patient data or AI algorithm testing with a specific test set.

• Sample Size for Test Set: Not applicable/not specified for a "test set" in the context of an AI/ML device. The underlying details of the sample sizes for each specific performance study (e.g., number of animals in the wound healing study, number of samples for tensile strength) are not provided in this summary.
• Data Provenance: Not applicable/not specified for an AI/ML device test set. The provenance of the data for the performance studies (e.g., which lab conducted the tests, what species for animal studies) is not detailed.

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

This information is not applicable. This 510(k) pertains to a wound dressing, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth on a test set. The listed studies are laboratory and preclinical performance tests.

4. Adjudication Method for the Test Set

This information is not applicable. There is no AI/ML test set requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an imaging or diagnostic AI/ML system that would typically undergo such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies refers to the direct measurement or observation of the physical, chemical, or biological properties and effects of the wound dressing.

• Biocompatibility: In-vitro (cytotoxicity, sensitization assays) and in-vivo (irritation, sensitization on animals/humans) test results.
• Wound Healing: Clinical and histological assessment of wound closure, tissue regeneration, inflammation in an animal model.
• Silver Dissolution: Analytical chemistry measurements of silver release.
• Tensile Strength: Physical testing measurements of material strength.
• Barrier Efficacy: Microbiological challenge tests demonstrating reduction of bacterial/fungal penetration.
• Zone of Inhibition: Microbiological growth assays on agar plates.
• Stability Testing: Comparison of pre- and post-aging performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that is "trained."

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

Not applicable. This device is not an AI/ML algorithm that is "trained."

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Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

Silverlon™ Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon™ Contact Wound Dressings consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. Silverlon™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.

The provided text describes the 510(k) Premarket Notification for the Silverlon™ Contact Wound Dressing. However, it does not contain specific acceptance criteria, a detailed study report comparing device performance against those criteria, or the methodology typically associated with AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will answer what can be extracted and clearly state what information is missing.

Request Analysis and Information Extraction

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

• Acceptance Criteria: Not explicitly stated in the document. The submission is focused on demonstrating "substantial equivalence" to existing predicate devices (Arglac, Acticoat, Tegapore) rather than meeting specific quantifiable performance targets. The "acceptance" by the FDA is based on this finding of substantial equivalence and adherence to general controls and specific labeling limitations.
• Reported Device Performance: Biocompatibility test results are described.

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

• Sample Size: Not specified. The document mentions "standard in vitro and in vivo biocompatibility tests" but does not detail the number of samples or subjects used in these tests.
• Data Provenance: Not specified, although the testing was conducted by North American Science Associates, Inc. (NAMSA), Northwood, Ohio, USA. The study type (retrospective/prospective) is not indicated, but given it's biocompatibility testing for a medical device, it would typically be prospective pre-clinical testing.

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)

• Not Applicable: This type of information is typically relevant for studies involving subjective human assessment or diagnostic accuracy, often with AI. The provided document details biocompatibility testing, which relies on standardized lab methods rather than expert consensus on ground truth in the way a diagnostic AI would.

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

• Not Applicable: Similar to point 3, adjudication methods are used to establish ground truth in subjective assessments. Biocompatibility testing results are typically objective measurements.

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

• No: The device described (Silverlon™ Contact Wound Dressing) is a physical wound dressing, not an AI/ML diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this product.

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

• No: As stated above, this is a physical medical device, not an algorithm.

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

• Ground Truth for Biocompatibility: The "ground truth" for the performance claims (safety and substantial equivalence) relies on the results of the "standard in vitro and in vivo biocompatibility tests including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study)." These tests follow ISO 10993 standards and represent scientifically established methods to determine biological responses to medical devices. The "ground truth" is therefore derived from standardized biological and chemical assays.

8. The sample size for the training set

• Not Applicable: This concept applies to AI/ML models, not physical medical devices.

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

• Not Applicable: This concept applies to AI/ML models, not physical medical devices.

Summary Table: Acceptance Criteria and Device Performance

Since explicit acceptance criteria are not provided, I will interpret "acceptance criteria" here as the general requirements for substantial equivalence and safety for a wound dressing, and "reported device performance" as the outcomes of the tests conducted.

Missing Information (as per original request and not present in document):

• Specific quantitative acceptance criteria (e.g., "cytotoxicity index must be

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