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For temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.

Topkin® foil is a synthetic, polymeric, transparent foil for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.

Topkin® adhesive is made from the same ingredients like the Topkin® foil plus Titanium dioxide and is used for the fixation of Topkin® foil on healthy skin. The fixation is mediated by cohesive forces between the Topkin® foil, the Topkin® adhesive and the healthy skin.

Material used:
Topkin® foil: Lactide-caprolactone copolymers
Topkin® Adhesive: 99 % Oligocaprolactone-co-lactide and 1 % Titanium dioxide

The provided documents are a 510(k) premarket notification and subsequent administrative update for the Topkin® Wound Dressing. These documents primarily focus on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative sense as might be expected for novel AI/diagnostic devices.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth for a performance study is not present in these documents. The submission relies on demonstrating similarity to an already approved device (Bioderm® thin film wound dressing) rather than independent performance validation against predefined criteria.

However, I can extract the information that is present and explain why other requested details are missing.

Here's a breakdown based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics for Topkin®, but rather implied by "substantial equivalence" to the predicate device. The performance of the predicate device (Bioderm®) sets the de-facto "acceptance criteria" through comparison.
• Reported Device Performance: The document states: "The effectiveness and substantial equivalence of Topkin® was determined by comparing relevant data. The results showed that Topkin® is at least equal to Bioderm® and thus fulfilled its intended use." And "The non-clinical performance data comparing Topkin® with the predicate device Bioderm® confirm that in all relevant properties Topkin® is at least as good as Bioderm and that both wound dressings are substantially equivalent in their indication and effect on the wound healing process and pain relief."

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The submission refers to "non-clinical performance data" and "relevant data" but does not give specific numbers of cases or subjects used in any comparative testing.
• Data Provenance: Not specified. It's unclear if this "relevant data" refers to in-house testing, literature review, or specific clinical trials. Given the 510(k) summary format for substantial equivalence, formal clinical trials (especially with large sample sizes) are often not required if bench testing and materials characterization are sufficient to show equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/Not mentioned. The submission focuses on material properties and equivalence to a predicate, not on a diagnostic task requiring expert-established ground truth.
• Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication method for the test set

• Adjudication method: Not applicable/Not mentioned. This type of adjudication is relevant for studies involving human interpretation or subjective assessments, which is not the primary focus here.

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

• MRMC Study: No, an MRMC study was not done. The device is a wound dressing, not an AI-assisted diagnostic tool.
• Effect size of human readers improving with AI: Not applicable, as this is not an AI device.

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

• Standalone Performance: Not applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly defined in terms of a "ground truth" for a performance study. Instead, the comparison is based on scientific concepts, physical/performance characteristics (e.g., transparency, permeability, degradation profile, biocompatibility, toxicological assessment), and the intended use of the predicate device (Bioderm®). The "truth" here is essentially the established properties and safety profile of the predicate device and the new device demonstrating similar characteristics.

8. The sample size for the training set

• Sample Size: Not applicable/Not mentioned. This is not an AI/machine learning device that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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