(268 days)
HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:
- Denture sores
- Oral ulcers (non-infected or viral)
- Periodontal surgical wounds
- Extraction sites
- Surgical wounds.
- 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.
| Acceptance Criteria Category | Specific Test / Property | Reported Device Performance (HealiAid® Dental) |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Non-cytotoxic |
| Genotoxicity (Ames test, Mammalian Cell Gene Mutation, Micronucleus Test - ISO 10993-3) | Non-genotoxic | |
| Systemic Toxicity (Acute & Subchronic - ISO 10993-11) | No acute/subchronic systemic toxicity | |
| Irritation (Intracutaneous reactivity - ISO 10993-23) | Non-irritant | |
| Sensitization (Guinea Pig Maximization - ISO 10993-10) | Non-sensitizing | |
| Implantation (in porcine gingiva - ISO 10993-6) | Very slight or non-tissue reaction | |
| Material-mediated pyrogenicity (USP 151) | Non-pyrogenic | |
| Physical/Chemical Properties | Collagen content | Demonstrated substantial equivalence |
| Carbohydrate analysis | Demonstrated substantial equivalence | |
| pH value analysis | Demonstrated substantial equivalence | |
| Thermal stability analysis | Demonstrated substantial equivalence | |
| Microstructure analysis | Demonstrated substantial equivalence | |
| Moisture content analysis | Demonstrated substantial equivalence | |
| Water absorption measurement | Demonstrated substantial equivalence | |
| Degradation | In vitro/in vivo degradation test | Similar timecourse of degradation to predicate (within 30 days in oral cavity) |
| Sterility & Shelf Life | Sterilization (Gamma irradiation, SAL 10-6) | Confirmed by testing |
| Viral Inactivation (ISO 22442 series compliance) | Compliant with ISO 22442 | |
| Shelf life (3-year stability) | Confirmed by real-time aging |
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.
N/A