(391 days)
Prescription: Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Luofucon Silver Alginate Dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and metallic silver particles, which absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The alginate material consists of metallic silver that provides effective protection against microbial contamination of the dressing material. Odour reduction results from the bacteria reduction effect in the dressing. The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x 100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
The provided text describes two medical devices, the "Luofucon Silver Alginate Dressing (Prescription)" and the "Luofucon Antibacterial Alginate Dressing (OTC)". Both devices are essentially the same product but marketed for different intended uses (prescription vs. over-the-counter). The acceptance criteria and the study to prove the device meets these criteria are primarily focused on their antibacterial activity and biocompatibility.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet requirements per ISO 10993-5 (Tests for in vitro cytotoxicity), ISO 10993-10 (Tests for irritation and skin sensitization), and ISO 10993-11 (Tests for systemic toxicity). The results should be comparable to predicate devices. | "Biocompatibility tests were conducted following procedures outlined in the respective consensus standards, and results for Luofucon Silver Alginate Dressing met all relevant requirements in the test standards, and are comparable to the predicate devices." (Same statement for Antibacterial Alginate Dressing OTC) |
| Antibacterial Activity | Demonstrate broad-spectrum antibacterial effectiveness against Gram-positive and Gram-negative bacteria, with a significant reduction (e.g., >99.99%) in bacterial count. The effect should be maintained for at least one day (given the instruction for daily changes). Results should be comparable to predicate devices when used as instructed. | "Luofucon Silver Alginate Dressing is effective (>99.99% reduction) for all 6 bacteria and effect lasts for one day." (Same statement for Antibacterial Alginate Dressing OTC). "The results are comparable to the predicate devices when the dressings are used for antibacterial purpose and changed daily during use." |
| Sterilization | Validated sterilization process. | "All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006." |
| Physical/Performance | Meet the requirements of its pre-defined acceptance criteria and intended uses (e.g., exudate absorption, moist wound environment, intact removal). | "It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses." (This is a general statement, specific quantitative metrics are not provided in the summary). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for the test set regarding the antibacterial activity study (AATCC 100-2004). It mentions "six (three Gram positive and three Gram negative) bacteria" were tested, but not the number of dressing samples or replicates per bacteria.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the studies were conducted by Huizhou Foryou Medical Devices Co., Ltd. in China, so the data would likely originate from their internal testing facilities. The nature of these tests (antibacterial efficacy, biocompatibility) implies they are prospective bench studies conducted specifically for this submission, rather than retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the studies described. The "ground truth" for these tests (biocompatibility, antibacterial activity) is established through standardized laboratory assays (e.g., ISO, AATCC standards), not by expert consensus or clinical assessment of a test set in the way a diagnostic imaging device might require.
4. Adjudication Method for the Test Set
This is not applicable as the studies are laboratory-based and do not involve human interpretation or adjudication of results in the traditional sense of clinical trials. The results are quantitative measurements against established scientific benchmarks.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the device's impact on their performance is assessed. The submitted information is for a wound dressing, and the studies focus on its physical, chemical, and biological properties, not on human interpretive performance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was done in the context of the antibacterial activity and biocompatibility testing. The "device" in this instance (Luofucon Silver Alginate Dressing) was tested directly and its performance was measured independently against established standards (AATCC 100-2004 for antibacterial activity, ISO 10993 series for biocompatibility). There is no "human-in-the-loop" component to these specific performance assessments.
7. Type of Ground Truth Used
The ground truth for the studies described is based on standardized laboratory test results and existing consensus standards.
- For antibacterial activity, the ground truth is defined by the AATCC 100-2004 standard, which dictates methods for quantitative bacterial reduction. The "truth" is the measured percentage reduction compared to controls.
- For biocompatibility, the ground truth is defined by the ISO 10993 series of standards, which specify acceptable levels for cytotoxicity, irritation, sensitization, and systemic toxicity. The "truth" is whether the device materials pass these established safety thresholds.
8. Sample Size for the Training Set
This information is not applicable. The device described is a physical medical dressing, not an AI/ML algorithm that requires a "training set" in the computational sense. The product's properties are inherent to its materials and manufacturing, not learned from data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as #8.
N/A