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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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