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The intended use of Cook® ECM Powder is for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic 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), draining wounds. The device is supplied sterile and is intended for one-time use.

Cook " ECM Powder is composed of porcine small intestinal submucosa (SIS) that has been processed to isolate the extracellular matrix (ECM), or medical-grade SIS. Further treatment and final sterilization yields a powdered device prepared for management of wounds. The powder is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

This document is a 510(k) summary for the Cook® ECM Powder, a medical device for wound management. The summary details the device's characteristics, its comparison to a predicate device, and the testing conducted to establish substantial equivalence.

Here's an analysis of the provided text with respect to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Oasis® Wound Matrix) based on material, intended use, and safety. The "acceptance criteria" in this context are implicitly that the new powdered form of the device maintains the safety and effectiveness of the sheet form, and that it passes various non-clinical tests.

The document states: "Any potential new risks associated with the change in shape of the predicate device from sheet to powder form have been identified by appropriate risk analysis techniques. These potential new risks have been addressed with verification and validation activities in a manner satisfactory to the pre-determined acceptance criteria to ensure that no change to device safety has occurred."

The "reported device performance" is essentially the successful completion of the non-clinical tests listed.

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

The document does not specify a "test set" in the context of clinical trials with human subjects. The testing described is non-clinical testing (e.g., biocompatibility, physical characterization) for a wound dressing. Therefore, concepts like sample size for a test set and data provenance (country, retrospective/prospective) are not directly applicable in the way they would be for an AI/ML-driven diagnostic device or a drug. The "samples" would be laboratory samples of the device material, not patient data.

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

Since this is not a diagnostic device relying on interpretation of medical images or patient data to establish "ground truth," this information is not relevant or provided. The "ground truth" for the non-clinical tests would be defined by validated laboratory methods and standards.

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

Not applicable, as there is no "test set" requiring expert adjudication in the context of this 510(k) summary for a wound dressing.

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 device is a wound dressing, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a wound dressing, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be established by:

• Biocompatibility: Standardized in vitro and in vivo testing protocols (e.g., ISO 10993 series) with defined pass/fail criteria.
• Physical/Chemical Characterization: Analytical chemistry techniques, microscopy, and validated testing methods to determine properties like particle size, heavy metal content, seal strength, etc.

8. The sample size for the training set:

Not applicable, as this is a physical medical device (wound dressing), not an AI/ML model.

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

Not applicable, as this is a physical medical device (wound dressing), not an AI/ML model.

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