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Endoform Silver Dermal Template is supplied sterile and is intended for single use in the management of the following wounds:

• partial and full-thickness wounds
• pressure ulcers
• venous ulcers
• diabetic ulcers
• chronic vascular ulcers
• tunnelled / undermined wounds
• surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
• draining wounds

Endoform Silver Dermal Template (Endoform Silver) is an advanced wound care dressing primarily composed of natural, non-reconstituted collagen retaining the native extracellular matrix associated macromolecules including fibronectin, glycosaminoglycans, laminin, and elastin. Endoform Silver is supplied as sterile intact or fenestrated sheets.

Endoform Silver contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, intended to prevent microbial colonization of the dressing is effective against a broad spectrum of microbes, including Acinetobacter baumannii, Candida parapsilosis, Candida glabrata, Candida albicans, Escherichia coli, Methicillin Resistant Staphylococcus aureus (MRSA), coagulase-negative Staphylococci, group A (betahemolytic) Streptococci, Pseudomonas aeruginosa, Aspergillus niger, and Vancomycin Resistant Enterococci (VRE). The dressing provides sustained antimicrobial effectiveness within the dressing for up to 7 days.

Endoform Silver is derived from ovine (sheep) extracellular matrix and it retains the innate biological structure of the native extracellular matrix. When rehydrated with exudate or sterile saline, Endoform Silver transforms into a soft conforming sheet, which is naturally incorporated into the wound over time.

The provided document is a 510(k) summary for the Endoform Silver Dermal Template, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study to prove device performance against specific acceptance criteria. Therefore, much of the requested information regarding a study design, sample sizes for training/test sets, expert qualifications, and ground truth establishment is not available in this document.

However, I can extract information related to the non-clinical performance data and the comparison to the predicate device.

Here's a breakdown of the available information based on your request:

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

The document does not provide a formal table of "acceptance criteria" for clinical performance. Instead, it states that "The acceptance criteria were met for all characteristics and comparison against the predicate and reference devices demonstrates equivalent performance" in the non-clinical testing section. The key performance claim for the subject device (Endoform Silver Dermal Template) is antimicrobial effectiveness.

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 for non-clinical tests (e.g., number of dressings tested for antimicrobial effectiveness, physical properties, etc.).
• Data Provenance: The tests are "in vitro performance testing" and "performance bench testing." No information on country of origin of data is provided specifically for these lab tests, but the company (Aroa Biosurgery) is based in New Zealand. These are lab-based tests, not human data.

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. The non-clinical performance data (e.g., antimicrobial effectiveness, physical characteristics) are measured objectively in a lab setting, not by expert interpretation.

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

Not applicable. This concept pertains to human interpretation/adjudication in clinical studies, which is not described for the non-clinical tests presented.

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 device (wound dressing) and the information provided refers to non-clinical performance, not an AI-driven diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm. The testing described is "standalone" in the sense that the device's physical and antimicrobial properties are tested independently.

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

For the non-clinical tests:

• Antimicrobial Effectiveness: The "ground truth" is measured by objective laboratory methods against known microbial cultures (e.g., measuring zones of inhibition, reduction in microbial count).
• Physical/Compositional/Safety Tests: The "ground truth" is established by adherence to recognized industry standards (e.g., ISO standards, USP, ANSI/AAMI), which define acceptable ranges and methodologies for measurement.

8. The sample size for the training set

Not applicable. This document describes a medical device undergoing non-clinical performance testing and substantial equivalence review, not an AI model requiring a training set.

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

Not applicable, as it's not an AI model.

Summary of the Study and Substantial Equivalence:

The document describes a 510(k) premarket notification for the Endoform Silver Dermal Template. The "study" described is a series of non-clinical performance tests conducted to demonstrate that the device is substantially equivalent to a legally marketed predicate device, the PriMatrix Ag Antimicrobial Dermal Repair Scaffold (K100261). A reference device, the Endoform Dermal Template (K092096), was also used for comparison of non-antimicrobial characteristics.

The primary difference of the subject device from the reference device is the addition of ionic silver for antimicrobial properties. The key finding from the non-clinical performance data is that the silver content in Endoform Silver Dermal Template successfully inhibits microbial colonization of the dressing for up to 7 days, making it comparable to the antimicrobial claim of the predicate device. All other physical, compositional, and safety characteristics were shown to meet acceptance criteria and be equivalent to the predicate/reference devices.

Crucially, the document explicitly states in section 5.5: "Substantial equivalence was not based on an assessment of clinical performance data." This means that no human clinical trials were conducted or presented in this submission to demonstrate the device's effectiveness in wound management on patients; the FDA clearance was based on equivalence of technological characteristics and non-clinical performance data to existing devices.

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