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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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The Aongen™ Collagen Matrix is intended for the management of wounds including:

• . surgical wounds
• trauma wounds t
• draining wounds .
• . second degree burns
• partial and full-thickness wounds .
• . pressure ulcers
• . venous ulcers
• vascular ulcers .
• . diabetic ulcers
• oral wounds and sores .

The Aongen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. The device is supplied sterile and for single use only.

The provided document describes a medical device called "Aongen™ Collagen Matrix," which is a wound dressing. The document is a 510(k) summary, indicating the device underwent a premarket notification process for substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide specific details on the sample size used for the biocompatibility tests or product characterization studies, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Tests were conducted to evaluate the biocompatibility" and refers to "product characterization studies."

This type of information is typically detailed in the full 510(k) submission, which is not fully included here. The summary provided is high-level.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided in this document. The device is a wound dressing, and the studies mentioned are laboratory-based (biocompatibility and product characterization), not clinical studies requiring expert interpretation of results to establish ground truth in the way it's done for diagnostic AI.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As mentioned above, the studies are laboratory-based, not clinical studies involving human readers or interpretation of complex data that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation is a key component, often comparing human performance with and without AI assistance. The Aongen™ Collagen Matrix is a wound dressing, and its evaluation focused on material properties and biological compatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical wound dressing, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used:

For the biocompatibility studies, the "ground truth" was established by compliance with the ISO 10993 standard. This standard outlines a series of tests (e.g., cytotoxicity, sensitization, irritation) and their acceptance criteria to ensure a material is biologically safe for its intended use. The results of these tests, as interpreted against the ISO 10993 requirements, formed the ground truth for biocompatibility.

For the product characterization studies (implied by "substantial equivalence"), the ground truth would typically be established by comparing the physical, chemical, and performance characteristics of the Aongen™ Collagen Matrix to those of the predicate devices. This involves material testing to ensure similar properties and performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical product (wound dressing) and not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

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