(343 days)
LUOFUCON® Silver PU Antibacterial Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, second-degree burns, donor sites, postoperative wounds and skin abrasions.
The proposed device, LUOFUCON® Silver PU Antibacterial Foam Dressing, is a sterilized, single-use dressing composed of soft, elastic PU foam and antibacterial coating including PVA and ionic silver particles, indicated for exudate absorption and the management of partial to full thickness wounds. The proposed device includes multiple sizes, which are listed in the following Table 1.
The provided text describes a 510(k) premarket notification for a medical device, the LUOFUCON® Silver PU Antibacterial Foam Dressing. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through extensive clinical trials. Therefore, the document does not contain details about acceptance criteria for a study proving device performance, nor does it describe a stand-alone study, MRMC study, or the comprehensive information requested regarding sample sizes, expert ground truth establishment, or adjudication methods.
However, it does describe the non-clinical tests conducted to support substantial equivalence. Here's a breakdown of the information that can be extracted, and where the requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the context of a clinical performance study with specific metrics like sensitivity, specificity, etc. Instead, it details non-clinical tests to establish biocompatibility and sterility, and an antibacterial efficacy test.
| Test Type | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility: | Complies with: | |
| In Vitro Cytotoxicity (ISO 10993-5) | Meet the requirements of ISO 10993-5 | ISO 10993-5: 2009 |
| Irritation/Skin Sensitization (ISO 10993-10) | Meet the requirements of ISO 10993-10 | ISO 10993-10: 2010 |
| Systemic Toxicity (ISO 10993-11) | Meet the requirements of ISO 10993-11 | ISO 10993-11:2006/(R)2010 |
| Sterility: | ||
| Sterilization Dose (ISO 11137-2) | Meet the requirements of ISO 11137-2 | ISO11137-2: 2012 (Sterility Assurance Level (SAL) of 10⁻⁶) |
| Bacterial Endotoxins Test (USP 36-NF 31: 2013 ) | Meet the requirements of USP 36-NF 31: 2013 | USP 36-NF 31: 2013 |
| Packaging Integrity: | ||
| Seal Strength (ASTM F88/F88M-09) | Meet the requirements of ASTM F88/F88M-09 | ASTM F88/F88M-09 |
| Internal Pressurization Failure Resistance (ASTM F1140-07) | Meet the requirements of ASTM F1140-07 | ASTM F1140-07 (Reapproved 2012) |
| Antibacterial Efficacy: | Demonstrate antibacterial preservative efficacy | Bacterial reduction of proposed device is greater than 4log for 7 days against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus faecalis, Klebsiella pneumonia, and Streptococcus pyogenes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the non-clinical tests mentioned (e.g., number of samples for cytotoxicity, irritation, or antibacterial tests). These are typically laboratory-based tests with controls.
- Data provenance: The document is a submission from Huizhou Foryou Medical Devices Co., Ltd. in P. R. China to the US FDA. The tests are non-clinical, so "country of origin for data" would refer to where the tests were performed, which is implicitly China based on the company's location. The tests are reported as part of a regulatory submission, indicating they were conducted to support the device's clearance. They are laboratory tests, not clinical studies, so the categories "retrospective or prospective" do not directly apply in the usual sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to the non-clinical tests described. "Ground truth" in this context typically refers to clinical diagnosis or pathology, which is not part of these physical/biological material tests. The "ground truth" for these tests would be the established scientific standards and methods outlined in the ISO and ASTM guidelines.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable to the non-clinical tests described. Adjudication methods are relevant for human interpretation or clinical outcomes, not for laboratory assays confirming material properties or antibacterial activity.
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 is for a medical dressing, not an AI-powered diagnostic device, and therefore this type of study is entirely irrelevant to its submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical dressing, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by adherence to recognized international standards (ISO, ASTM, USP) for biocompatibility, sterility, packaging, and general laboratory practices for antibacterial efficacy. There is no expert consensus, pathology, or outcomes data used as ground truth for these material-based tests.
8. The sample size for the training set
- Not applicable. Training sets are used for machine learning models. This document describes a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
N/A