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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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The Acticoat® Calcium Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic wounds. Acticoat® dressings may be used over debrided and partial thickness wounds.

The Acticoat® Calcium Alginate Dressing is a highly absorbent non-woven calcium alginate fabric with an Acticoat® coating applied directly to its surface. It has a light grey appearance. Formatted in various sizes (5cm x 5cm, 10cm x 12.5cm, 15cm x 15cm, and a 2.5cm x 30cm rope) and packaged in Tyvek pouches.

The provided text is a 510(k) summary for the Acticoat® Calcium Alginate Dressing. It details the device's description, indications for use, and a summary of substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria from a performance standpoint.

The "Testing" section broadly states:

"The biocompatability of Acticoat® Calcium Alginate Dressing has been demonstrated in accordance with 1999 ISO 10993-1. In vitro and in vivo testing has demonstrated the characteristics of Acticoat® Calcium Alginate Dressing are substantially equivalent to the predicate devices."

This indicates that biocompatibility testing was performed according to ISO standards, and other in vitro/in vivo testing was done to show equivalence to predicate devices. However, it does not specify what those "characteristics" were, what the acceptance criteria for those characteristics were, or the detailed results of those tests.

Therefore, I cannot fill out the requested table and answer many of the questions as the specific performance study details are not present in the provided document.

Here's an attempt to answer based only on the available information, noting where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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 for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/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)

• Not applicable as this is a medical device (dressing) and the testing mentioned is more related to material properties and biological interaction than diagnostic accuracy requiring expert ground truth.

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

• Not applicable for the type of testing described (biocompatibility, in vitro/in vivo material characteristics).

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 medical dressing, not an AI diagnostic or assistive device.

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

• Not applicable. This is a medical dressing, not an algorithm.

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

• For biocompatibility, the ground truth would be established by the ISO 10993-1 standard itself, which defines acceptable biological responses. For in vitro/in vivo "characteristics," the ground truth would likely be defined by established ASTM or other international standards/methods for material properties, absorbency, bacterial barrier properties, etc., which are then compared to the predicate devices. Specific details are not provided.

8. The sample size for the training set

• Not applicable in the context of this device and the presented testing summary. No "training set" for an algorithm is mentioned.

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

• Not applicable.

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