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The Acticoat® Moisture Control dressing, an addition to the Acticoat® Dressing line of products is intended as an absorbent dressing which provides an effective barrier to bacterial penetration. Acticoat® Moisture Control Dressing is indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Acticoat® Moisture control may be used over debrided and partial thickness wounds.

The absorbent, antimicrobial barrier dressing consists of three layers. An outer blue polyurethane film layer, a central polyurethane foam layer and a nanocrystalline silver coated polyurethane film wound contact layer. The layers are heat laminated together to form a single dressing. The dressing can be cut to size and maintains its antimicrobial activity for up to 7 days.

This 510(k) premarket notification for K050030, the Acticoat® Moisture Control Dressing, is for a wound dressing and as such, does not involve the typical software-driven device acceptance criteria and studies you might expect for an AI/ML product. The submission is focused on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not applicable to this type of device submission.

Instead, the "acceptance criteria" for this submission are met by demonstrating the following:

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

Regarding the specific questions which are NOT applicable to this 510(k) submission for a wound dressing:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a wound dressing substantial equivalence submission. Performance data for a direct animal or human study for this specific claim of equivalence is not detailed in the summary.
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. "Ground truth" in the context of AI/ML models is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set: Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document demonstrates substantial equivalence by comparing the new device's intended use, technological characteristics (materials, design, manufacturing), and biocompatibility to a predicate device (Acticoat® Foam Dressing K000051) which has already been deemed safe and effective. The FDA's acceptance of this submission means they agreed that the Acticoat® Moisture Control Dressing is substantially equivalent to the predicate and does not raise new questions of safety or effectiveness.

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Advanced Medical Solutions Ltd's Antimicrobial Alginate. Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal. The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.

This document describes the 510(k) summary for Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance metrics (accuracy, sensitivity, specificity, AUC), or details of a study with sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K002896 Acticoat Calcium Alginate Dressing) based on similarities in:

• Materials (calcium alginate and silver)
• Intended use and indications for use
• Product description and functional characteristics (absorbent, sterile, sustained silver release, antimicrobial effect, barrier to bacterial penetration, maintains moist wound environment, intact removal, similar dressing change frequency)
• Biocompatibility (demonstrated in accordance with BSENISO 10993-1)
• Sterilization method (gamma irradiation)
• Contraindications
• Product sizes and variants

The document states: "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." However, it does not provide specific performance metrics or detailed results from this in vitro testing, nor does it detail a clinical study with the requested elements.

Therefore, I cannot populate the table or answer most of the questions as the provided text does not contain that specific information.

Summary of available information regarding performance and studies:

1. A table of acceptance criteria and the reported device performance:
   Not provided in the document. The document focuses on demonstrating substantial equivalence rather than reporting specific performance metrics against set acceptance criteria for metrics like accuracy, sensitivity, specificity, or AUC.

2. Sample size used for the test set and the data provenance:
   Not provided. The document mentions "Additional in vitro testing" but does not detail sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no human-in-the-loop study with a test set requiring expert ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable.

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 device is an antimicrobial dressing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   The document mentions "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." This suggests some form of standalone testing was performed to compare its characteristics to the predicate, but no specific performance metrics like those for an algorithm are detailed. The device is a physical dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not explicitly stated for the "in vitro testing." Given the nature of an antimicrobial dressing, ground truth would likely relate to microbiological growth inhibition, fluid absorption, or silver release rates, rather than expert consensus on images or pathology.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device with a training set in the conventional sense.

9. How the ground truth for the training set was established:
   Not applicable.

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ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including:

• pressure ulcers .
• venous ulcers .
• diabetic ulcers ●
• first and second-degree burns ●
• . donor sites
• surgical wounds ●

ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging.

ACTISORB* Silver 220 Antimicrobial Binding Dressing is a sterile primary wound dressing, comprised of activated charcoal cloth, impregnated with silver, within a spun bonded nylon envelope. Within the dressing, there is 220mg silver per 100g activated charcoal cloth equating to 33ug of silver per square centimeter of cloth.

1. Acceptance Criteria and Reported Device Performance:

The provided document describes the ACTISORB Silver 220 Antimicrobial Binding Dressing* as a wound dressing. The acceptance criteria and device performance are not explicitly presented in a table format with specific quantitative metrics in the provided text.

However, the "Device Description" and "Indications for Use" sections imply general performance characteristics against which the device is implicitly accepted:

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

The provided text (K022483 510(k) summary) does not contain information about a specific "test set" in the context of clinical studies for diagnostic device performance. This submission is for a wound dressing, and the focus is on substantial equivalence to existing predicate devices based on its physical properties and intended use. The "biocompatibility studies" are mentioned, but details on sample size, design, or data provenance (country, retrospective/prospective) are not provided.

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

This information is not applicable to the provided document. The submission is for a wound dressing, which typically relies on pre-clinical testing (e.g., in-vitro antimicrobial efficacy, biocompatibility) and clinical experience with similar devices, rather than a "ground truth" established by experts for a diagnostic output.

4. Adjudication Method for the Test Set:

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

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

No. The provided 510(k) summary does not mention or describe a multi-reader multi-case comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human readers interpret results.

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

No. This is a medical device (wound dressing), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant or applicable.

7. The Type of Ground Truth Used:

As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic studies is not directly applicable here. The evidence for the device's performance appears to be based on:

• In-vitro testing: Implied by the statement "ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor..." and "Biocompatibility studies have demonstrated..."
• Clinical experience/literature: Supporting the indications for use in various wound types, likely drawing from evidence related to silver and charcoal dressings.
• Substantial equivalence: The primary "proof" for regulatory clearance is establishing substantial equivalence to legally marketed predicate devices with similar materials and intended use.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/algorithm-based device that would require a "training set."

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

This information is not applicable as this is not an AI/algorithm-based device that would require a "training set."

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