(228 days)
Coreleader Colla-Pad Wound Dressing is indicated 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-Mohs surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
Coreleader Colla-Pad is comprised of a porous matrix of cross-linked bovine collagen. Colla-Pad is made of highly absorbent material that converts to a soft, gel sheet that stays in intimate contact with the wound bed as it absorbs exudate t. The moisture held around the wound by Colla-Pad could provide a favorable wound healing environment. Coreleader Colla-Pad is easy to cut and apply. Cut to fit any size of acute or chronic wounds with light to heavy exudate. Coreleader Colla-Pad is a sterile topical wound dressing, packed in a foil pouch and a foil package and sterilized by r-ray radiation to a 10to SAL.
The provided text is a 510(k) summary for the Coreleader Colla-Pad, a collagen wound dressing. This document confirms the device's substantial equivalence to predicate devices for its intended use. However, it does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically requested for AI/software devices.
The document discusses the device description, intended use, technological characteristics, and biocompatibility testing. The biocompatibility section mentions ISO 10993-11 for systemic toxicity, blood analysis, and histological analysis showing no inflammation reaction in test animals, but this is a safety assessment, not a performance study comparing the device against specific acceptance criteria for efficacy.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
- Sample sized used for the test set and the data provenance: Not applicable as a performance study with a test set is not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device.
- The type of ground truth used: Not applicable, as performance efficacy is not detailed.
- The sample size for the training set: Not applicable, as this is not an AI/software device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/software device.
The 510(k) submission primarily focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety (biocompatibility) compared to existing legally marketed devices, rather than presenting a detailed clinical performance study with specific acceptance criteria.
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