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HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:

1. Denture sores
2. Oral ulcers (non-infected or viral)
3. Periodontal surgical wounds
4. Extraction sites
5. Surgical wounds.
6. Traumatic wounds

The subject device is HealiAid® Dental Collagen Wound Dressing (HealiAid Dental) that is a white, porous, pliable and absorbable collagen wound dressing. HealiAid Dental is fabricated by fibrous collagen matrix purified from bovine Achilles tendons. HealiAid Dental is pliable and can be applied easily to oral wounds to protect the wound bed. The product is supplied in a sterile, nonpyrogenic package, and is indicated for single use only.

The provided text describes the regulatory clearance (510(k)) for the HealiAid® Dental Collagen Wound Dressing. This is a medical device, not an AI/ML software device, and therefore the concepts of acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), sample size for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, or training sets are not applicable here.

Instead, the acceptance criteria for this medical device are related to its physical and biological properties, and its performance in pre-clinical studies to demonstrate substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the information provided, framed to address the prompt's categories where applicable for a medical device without AI/ML components:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like wound dressings, "acceptance criteria" are typically defined by demonstrating compliance with established standards (like ISO 10993 for biocompatibility) and exhibiting comparable performance to predicate devices in pre-clinical tests.

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

• Test Set (Pre-clinical Studies): The document does not specify exact sample sizes for each pre-clinical test (e.g., number of animals for toxicity or implantation studies). These studies are typically conducted according to standardized protocols outlined in documents like ISO 10993, which define appropriate sample sizes for each test type.
• Data Provenance: The studies were pre-clinical (laboratory and animal studies) rather than human clinical trials. The bovine Achilles tendons are the source material.

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

• This is not applicable as the "ground truth" for this type of device is established through standardized laboratory tests and animal models, adhering to recognized international standards (e.g., ISO 10993, USP 151, ISO 22442). These tests have defined endpoints and criteria, and their interpretation is generally performed by qualified laboratory personnel following strict protocols, rather than a consensus of human "experts" evaluating an outcome like an image.

4. Adjudication Method for the Test Set

• Not applicable. The pre-clinical tests have objective measurements and pass/fail criteria based on established standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not applicable. MRMC studies are specific to diagnostic devices (often imaging-based AI) where multiple human readers interpret cases, and their performance is compared with and without AI assistance. The HealiAid® Dental Collagen Wound Dressing is a therapeutic/wound management device, not a diagnostic one.

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 and does not involve an algorithm or AI functionality.

7. The Type of Ground Truth Used

• For the pre-clinical studies, the "ground truth" is established by the objective results of standardized biological and chemical tests (e.g., cell viability in cytotoxicity, presence/absence of mutagenic activity in genotoxicity, tissue reactions in implantation, absorption values, degradation rates). These are verifiable scientific outcomes, not interpretations of medical images or pathology.

8. The Sample Size for the Training Set

• Not applicable. This device does not use AI/ML and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable for the same reason as above.

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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:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance: Not applicable as a performance study with a test set is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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, as this is not an AI/software device.
6. 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.
7. The type of ground truth used: Not applicable, as performance efficacy is not detailed.
8. The sample size for the training set: Not applicable, as this is not an AI/software device.
9. 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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