(215 days)
The Silicone Ag Foam Dressing (OTC) /Silicone Ag Foam Dressing with Border (OTC)/ Ag Foam Dressing Non-adhesive (OTC) and Ag Foam Dressing Adhesive (OTC) are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor cuts, minor abrasions, minor lacerations, and minor burns.
It is a sterile, single-use dressing, the foam layer contain about 0.25-0.35mg/cm2 silver. The dressing absorbs wound exudate and releases silver ions within the dressing in the presence of wound fluid to help reduce bacterial colonization of the dressing. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The devices are available in four configurations: Ag Foam Dressing Non-adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, and Silicone Ag Foam dressing with Border. The dressing has light yellow or light brown appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro.
Here's a breakdown of the acceptance criteria and study information for the Ag Foam Dressing, based on the provided document:
This document pertains to the 510(k) clearance of Ag Foam Dressings and does not describe acceptance criteria for an AI/ML powered device. Instead, it details the substantial equivalence of the proposed medical device to existing predicate devices. The "acceptance criteria" in this context refer to the demonstration that the new device is as safe and effective as the predicate devices, primarily through non-clinical testing and comparison of characteristics.
Since this is a filing for a wound dressing and not an AI/ML device, many of the requested fields (like "AI vs without AI assistance," "standalone algorithm performance," "training set size," "ground truth for training set") are not applicable and will be marked as such.
Acceptance Criteria and Device Performance for Ag Foam Dressings
1. Table of Acceptance Criteria (Non-Clinical Standards) and Reported Device Performance
For medical devices like wound dressings, "acceptance criteria" are typically met by demonstrating compliance with established international standards for safety and performance (biocompatibility, sterility, absorbency, etc.) and by showing substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | Complied |
| ISO 10993-6:2016 (Local effects after implantation) | Complied | |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | Complied | |
| ISO 10993-11:2017 (Systemic Toxicity) | Complied | |
| Sterilization Residuals | ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals) | Complied |
| Sterility Assurance | ISO 11135-1:2014 (EtO Sterilization Validation) | Sterilized by EtO (SAL: 10⁻⁶) |
| ISO 11137-2:2013 (Irradiation Sterilization Validation) | Sterilized by gamma irradiation (SAL: 10⁻⁶) | |
| Antimicrobial Effectiveness | Antimicrobial effectiveness test | Shown to have antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro. |
| Physical Performance | Liquid absorbency | Conducted, results demonstrated compliance (specific values not provided but implied as acceptable). |
| Waterproofness | Conducted, results demonstrated compliance. | |
| Moisture vapor transmission rate | Conducted, results demonstrated compliance. | |
| Packaging Seal Integrity | ASTM F88/F88M-15 (Seal Strength) | Complied |
| ASTM F1929-15 (Detecting Seal Leaks by Dye Penetration) | Complied | |
| Bacterial Endotoxins | USP Bacterial Endotoxins Test | Complied (Bacterial Endotoxin) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for absorbency, or number of biological replicates for cytotoxicity). It states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Sample Size: Not explicitly stated for individual tests. The phrasing implies sufficient samples were used to meet the requirements of the standards cited (e.g., ISO, ASTM, USP).
- Data Provenance: The tests were conducted internally by Winner Medical Co., Ltd. or by contract labs following international standards. The provenance is therefore laboratory-based, for the purpose of demonstrating device performance and safety. It is not patient or country-specific data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device submission for wound dressings, not an AI/ML device where expert ground truth for interpretation would be relevant. The "ground truth" here is compliance with established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device submission for wound dressings, not an AI/ML device requiring adjudication of diagnostic interpretations. The "adjudication" is compliance with documented test protocols and standards.
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. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this medical device clearance is based on:
- Compliance with International Standards: The device's physical, chemical, and biological properties were evaluated against recognized standards (ISO 10993, ISO 11135, ISO 11137, ASTM F88/F88M-15, ASTM F1929-15, USP ).
- Substantial Equivalence: The device's characteristics (intended use, mechanism, material, sterilization, biocompatibility, antibacterial duration, single use) were compared to legally marketed predicate devices, with detailed comparisons provided in Table 1 (pages 8-9).
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a medical device, not an AI/ML device that requires a training set and its associated ground truth establishment.
N/A