(510 days)
Prescription Use: LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
OTC Use: LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.
- (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
- (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.
Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.
The provided text describes the regulatory clearance of a medical device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/ML performance.
The document is a 510(k) Premarket Notification from the FDA for a wound dressing, specifically the LUOFUCON® Silicone Ag+ Foam Dressing. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through AI/ML performance metrics.
The "Performance Data" section (page 7) details various performance testing related to the physical and biological characteristics of the wound dressing, such as:
- Adhesive property: conducted with ASTM D6195-03
- Water absorbency: conducted with BS EN 13726-1
- pH Value: conducted with USP pH.
- MVTR (Moisture Vapor Transmission Rate): conducted with BS EN 13726-2
- Waterproofness: conducted with BS EN 13726-3
- EO and ECH residuals: conducted with ISO 10993-7
- Antibacterial effectiveness: in vitro simulated use testing.
- Sterility: conducted with ISO 11737-2:2019
- Biocompatibility testing (Cytotoxicity, Implantation, Intracutaneous Reactivity, Sensitization, Systemic toxicity, Material-mediated pyrogenicity) according to ISO 10993 standards.
- Animal Study: A Porcine Wound Healing Study.
The document explicitly states: "No clinical studies were conducted for the subject device." and there is no mention of any AI/ML components in the device or its evaluation. Therefore, I cannot extract the requested information regarding acceptance criteria, AI/ML device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and studies proving AI device performance.
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