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The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

The proposed Kendall Xeroform Petrolatum Wound Dressing is a sterile, singleuse, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. It is packaged in metalized chevron pouches and is available in 4" x 3yd roll, 1" x 8", 5" x 9", 2" x 2" and 4" x 4" sizes.

The provided document is a 510(k) summary for the Kendall Xeroform Petrolatum Wound Dressing. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific device performance against acceptance criteria from a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted as it pertains to a traditional clinical performance study for an AI/CADe device. The provided text describes the device's characteristics and its equivalence to a predicate device based on material, function, and indication for use, alongside biocompatibility testing. It is not a document describing the results of a controlled clinical trial with performance metrics.

I can, however, extract the relevant information that is present regarding non-clinical testing and the comparison method:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not applicable. The document discusses device characteristics and performance in terms of biocompatibility and equivalence, not a test set of data points for an algorithm.
• Data Provenance: Not applicable.

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

• Not applicable. This is not a study involving expert-established ground truth for a test set.

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:

• No MRMC comparative effectiveness study was done. This document does not describe an AI/CADe device.

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

• No standalone algorithm performance study was done. This is not an algorithmic device.

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

• Not applicable in the context of an algorithm's ground truth. However, the ground for the device's safety and effectiveness relies on biocompatibility testing standards and demonstration of substantial equivalence to a previously marketed device (Sherwood Medical Xeroform Petrolatum Dressing) which was already deemed safe and effective.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

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