(248 days)
The proposed devices are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
The subject devices are sterile, single-use dressings, the polyurethane foam contain about 0.5% (w/w) Polyhexamethylene Biguanide (PHMB), an agent that is intended to resist bacterial colonization within the dressing. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressings have demonstrated to be effective against colonization and proliferation of bacteria within the dressing for up to 7 days. The proposed device in this submission consists of four variants: PHMB Foam Dressing Non-adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, and Silicone PHMB Foam Dressing with Border.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance for clinical endpoints. Instead, it focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device. The performance is assessed by compliance with various ISO and ASTM standards and antimicrobial effectiveness tests.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | Complies with the standard |
| ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals) | Complies with the standard | |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | Complies with the standard | |
| ISO 10993-11:2017 (Systemic Toxicity) | Complies with the standard | |
| Biocompatibility in accordance to ISO 10993-1 | No new questions of safety or effectiveness raised (compared to predicate) | |
| Packaging & Sterility | ASTM F88/F88M-15 (Seal Strength) | Complies with the standard |
| ASTM F1929-15 (Detecting Seal Leaks) | Complies with the standard | |
| USP (Bacterial Endotoxins Test) | Complies with the standard | |
| Sterilization (EtO for some variants, Irradiation for others) | Conditions validated following ISO 11135:2014 and ISO 11137-2:2013 | |
| Antimicrobial Effectiveness | Modified AATCC 100 | Reduction of Staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomona aeruginosa, MRSA, VRE, Klebsiella |
| Antibacterial Duration | (Implicitly tested via Modified AATCC 100) | 7 days |
2. Sample Size Used for the Test Set and Data Provenance
- The document describes non-clinical tests conducted to verify compliance with standards and demonstrate substantial equivalence. These are laboratory-based tests on device samples, not human clinical trials.
- Therefore, there is no "test set" in the sense of patient data. The sample sizes for the individual non-clinical tests (e.g., number of foam dressing samples for seal strength, bacterial reduction assays) are not specified in this summary.
- Data provenance is not applicable in the context of human data, as no clinical studies were performed. The tests were performed by the manufacturer, Winner Medical Co., Ltd. in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as no clinical test set with human data and expert-established ground truth was used. The "ground truth" for the non-clinical tests is defined by the international standards themselves and the inherent properties of the materials and biological assays.
4. Adjudication Method for the Test Set
- This is not applicable as no clinical test set requiring expert adjudication was used.
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
- No, an MRMC comparative effectiveness study was not done. This document describes a medical device (wound dressing), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical wound dressing, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" is defined by:
- Validated laboratory testing procedures according to recognized international standards (ISO, ASTM, USP).
- Established biological principles for cytotoxicity, irritation, systemic toxicity, and antimicrobial efficacy.
- Reference materials and controls used within these standard test methods.
8. The Sample Size for the Training Set
- This is not applicable. There is no "training set" as this is a physical medical device and not an AI/machine learning model.
9. How the Ground Truth for the Training Set was Established
- This is not applicable as there is no training set.
N/A