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CollaWound™ Hydrogel is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.

CollaWound™ Hydrogel is a collagen-based emulsion/liquid formulation comprising collagen derived from porcine hides. It is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.

The provided text describes a 510(k) submission for a wound dressing called CollaWound™ Hydrogel. It focuses on demonstrating substantial equivalence to a predicate device and safety through biocompatibility testing. The document does not describe a study involving a "device" in the context of an AI/ML algorithm or software that would have performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested elements for describing an AI study are not applicable to this submission.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

This information is not applicable as the submission is for a material-based wound dressing, not a software or AI device with performance metrics. The "acceptance criteria" here relate to meeting biocompatibility standards and demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not an AI/ML algorithm study. The "testing" involved biocompatibility tests on the material itself.

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.

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

Not applicable.

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

Not applicable.

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

Not applicable. For biocompatibility, the "ground truth" is adherence to established international standards (ISO 10993/G95-1).

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of the Study:

The "study" described in the 510(k) summary for CollaWound™ Hydrogel primarily consists of biocompatibility testing to ensure the material is safe for its intended use, and a comparison to a legally marketed predicate device to demonstrate substantial equivalence.

• Biocompatibility Study: The submission confirms that CollaWound™ Hydrogel underwent biocompatibility tests that met the requirements of ISO 10993/G95-1. This ensures the device material does not cause adverse biological reactions when in contact with the body. Details about the specific tests performed (e.g., cytotoxicity, sensitization, irritation, etc.), the number of samples, or the outcome of individual tests are not provided in this summary.
• Substantial Equivalence Study: The core of a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. The submission states that CollaWound™ Hydrogel is "substantially equivalent in material, function, technological characteristics and intended use to its predicate." The specific predicate device is not named in the provided text, but the claim of equivalence is a key finding for the FDA's approval. This often involves comparing device specifications, materials, manufacturing processes, intended uses, and any performance data if relevant.

In conclusion, the provided documentation focuses on the safety and equivalence of a physical wound dressing material, not on the performance of a digital or AI-driven diagnostic or treatment device. Therefore, the questions related to AI/ML study design are not relevant to this specific FDA submission.

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