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The XCelliStem Wound Powder is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, tunneled/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), and draining wounds. The device is intended for one-time use.

The XCelliStem Wound Powder is an extracellular matrix composed of porcine collagen for the management of wounds. It is white to off-white particulate that is to be used as a topical application. The product is provided sterile, for single use.

The provided text is a 510(k) Premarket Notification for the XCelliStem Wound Powder. It outlines the regulatory process, intended use, and a comparison to predicate devices, focusing on biocompatibility, non-clinical, and clinical testing to establish substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study that proves a device meets specific performance criteria in the context of an AI/algorithm-driven device. There is no mention of accuracy metrics, sensitivity, specificity, or any statistical evaluation of performance that would typically be associated with such a study. The information provided heavily emphasizes physical, chemical, and biological characteristics to demonstrate equivalence to existing wound dressings.

Therefore, I cannot fulfill your request with the provided text. The document does not describe the kind of study you are asking about (e.g., related to AI performance, human reader improvement with AI assistance, MRMC studies, ground truth establishment for a diagnostic algorithm).

The response to your request would be:

The provided document, K172593 for the XCelliStem Wound Powder, does not contain information about acceptance criteria or a study proving the device meets performance criteria in the context of an AI/algorithm-driven device. The 510(k) submission focuses on demonstrating substantial equivalence to predicate wound dressings through biocompatibility, non-clinical, and limited clinical testing, not on algorithm performance metrics. Therefore, I cannot provide the requested table or details about an AI performance study.

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