(54 days)
Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to fullthickness 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 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 is a 510(k) Summary for a medical device (LUOFUCON® Silicone Ag+ Foam Dressing). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/software component, which is what your request implies about typical 'acceptance criteria' and 'study' information.
Therefore, I cannot extract the information you requested about AI/software performance, such as:
- Table of acceptance criteria and reported device performance (for AI/software): The document reports performance testing for the physical dressing (e.g., adhesive property, water absorbency, pH value, MVTR, waterproofness, antibacterial effectiveness, sterility), but not for any AI/software components.
- Sample size for the test set and data provenance: Not applicable as there's no AI/software test set.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, I can provide the acceptance criteria and performance data for the physical medical device as reported in the document:
The document describes various performance tests conducted to ensure the subject device is substantially equivalent to the predicate device. It doesn't present these as strict "acceptance criteria" with numerical targets in a table, but rather lists the tests performed and implies that the device "met all design specifications" and was "Substantially Equivalent (SE)" to the predicate with identical performance specifications.
Here's a summary of the performance tests mentioned for the physical device:
Performance Testing for LUOFUCON® Silicone Ag+ Foam Dressing
| Test | Standard Applied | Reported Device Performance |
|---|---|---|
| Adhesive property | ASTM D6195-03 | Met design specifications (implied by SE claim) |
| Water absorbency | BS EN 13726-1 | Met design specifications (implied by SE claim) |
| pH Value | USP pH | Met design specifications (implied by SE claim) |
| MVTR (Moisture Vapor Transmission) | BS EN 13726-2 | Met design specifications (implied by SE claim) |
| Waterproofness | BS EN 13726-3 | Met design specifications (implied by SE claim) |
| EO and ECH residuals | ISO 10993-7 | Met design specifications (implied by SE claim) |
| Antibacterial effectiveness | In vitro simulated use testing | Effective for up to 7 days (as described in device description) |
| Sterility | ISO 11737-2:2019 | Met design specifications (implied by SE claim) |
Additional Context from the document:
- Study Design/Purpose: The overall study described in the 510(k) submission is to demonstrate substantial equivalence of the LUOFUCON® Silicone Ag+ Foam Dressing to a legally marketed predicate device (K223360), not to establish novel performance criteria for an AI/software component.
- Modifications: The only modification to the predicate device was the addition of a new, larger size to the Non-Bordered and Transfer models. The document states, "the material properties of the subject device and predicate device remain the same and the performance specifications are also identical, the difference in size does not affect the effectiveness of the product."
- Clinical Study: No clinical studies were conducted for the subject device.
- Biocompatibility Testing: No additional biocompatibility tests were conducted for this submission. All biocompatibility data were leveraged from the predicate device (K223360) and included tests according to ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and USP 41-N36.
- Ground Truth (for the physical device): The "ground truth" for the physical device performance is established by adherence to recognized international and national standards (ASTM, BS EN, USP, ISO). The reported performance indicates that the device met the requirements of these standards and, by extension, is substantially equivalent to a predicate device that also meets these standards.
N/A