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The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns.

It is a sterile, single-use dressing, the foam layer contain about 0.25-0.35mg/cm2 silver. The dressing absorbs wound exudate and releases silver ions within the dressing in the presence of wound fluid to help reduce bacterial colonization of the dressing. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The proposed devices are available in four configurations:

The basic configuration, Ag Foam Dressing Non-adhesive, consist of a top layer (Vapor permeable and waterproof polyurethane film); a soft, absorbing polyurethane (PU) antimicrobial foam contain silver compounds adhered to the top film with acrylic adhesive. The film backing has the same area as the polyurethane foam layer. The is available in different sizes.

A second adhesive configuration, Ag Foam Dressing Adhesive, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A thin non-woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a release liner (covered on the foam pad and top film border part). The product line is available in different sizes.

A third adhesive configuration, Silicone Ag Foam Dressing, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated laminate of acrylic adhesive/polyurethane film/silicone gel, where the acrylic adhesive adheres to the top film, and the silicone gel is for skin adherence); a release liner covers on the silicone gel. The product line is available in different sizes.

A forth adhesive configuration, Silicone Ag Foam dressing with Border, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A supper absorbent fiber pad, a thin non-woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a wound contact layer (Perforated silicone gel adhered to the center layer and top film); a release liner (covered on the silicone gel).

The dressing has light yellow or light brown appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro.

Silicone Ag Foam Dressing and Silicone Ag Foam Dressing with Border are sterilized and sold directly to users after sterilized by EtO using conditions validated following ISO 11135-1: 2014. Ag Foam Dressing Non-adhesive and Ag Foam Dressing Adhesive are sterilized and sold directly to users after sterilized by irradiation using conditions validated following ISO 11137-2: 2013.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device (Ag Foam Dressing variations) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria for a new device's performance against clinical endpoints. Therefore, many of the requested fields related to clinical studies and AI performance cannot be directly extracted as they are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted, and where the requested information is not present:

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

For a 510(k) submission, "acceptance criteria" often refer to meeting established standards and demonstrating similarity to predicate devices rather than specific performance metrics against clinical outcomes in a new clinical study. The device is being cleared based on substantial equivalence, which implies it performs as well as the predicate.

2. Sample sized 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 as it focuses on non-clinical testing for standards compliance and substantial equivalence argument, not a clinical trial with a "test set" in the context of diagnostic or AI performance. The data provenance for the comparison to predicate devices states: "These data came from commercially product labeling and 510(k) 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)

This information is not applicable/not provided. The submission is a 510(k) for a wound dressing, not a diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable/not provided.

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/not provided. This is a wound dressing, not an AI-powered diagnostic tool.

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

This information is not applicable/not provided. This is a wound dressing.

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

For the non-clinical tests (e.g., biocompatibility, seal strength), the "ground truth" is defined by the standards themselves. For the substantial equivalence comparison, the "ground truth" is the performance and characteristics of the legally marketed predicate devices as described in their 510(k) summaries and product labeling.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device submission.

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

This information is not applicable/not provided. There is no training set mentioned.

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