(80 days)
LUOFUCON® Silicone Ag Foam Dressing with Border is indicated for the management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.
LUOFUCON® Silicone Ag Foam Dressing with Border has a multilayer structure, it consists of a soft silicone wound contact layer, an absorbent polyurethane foam pad containing about 0.25~0.35mg/cm² silver ions, a supper absorbent fibre pad, a vapor permeable waterproof film, and release PE films. LUOFUCON® Silicone Ag Foam Dressing with Border 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. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014.
The provided text is a 510(k) summary for a medical device (LUOFUCON® Silicone Ag Foam Dressing with Border). It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner you've requested (e.g., performance metrics with statistical significance, sample sizes for test sets, expert ground truth adjudication).
This document is a regulatory submission focused on demonstrating equivalence to already approved devices, not necessarily a detailed report of a new clinical or performance study with acceptance criteria listed in a typical research format.
Here's a breakdown of the information that can be extracted, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | No Toxic Effect (ISO 10993-5) | No Toxic Effect (ISO10993-5) |
| Skin Irritation | No Effect (ISO 10993-10) | No Effect (ISO 10993-10) |
| Skin Sensitization | No Effect (ISO 10993-10) | No Effect (ISO 10993-10) |
| Systemic Toxicity | No Effect (ISO 10993-11) | No Effect (ISO 10993-11) |
| Antibacterial Activity | >4 log reduction for seven days for six bacteria (implied a standard for silver dressings) | >4 log reduction for seven days for all six bacteria |
| Antibacterial Duration | Seven days (comparable to predicate devices) | Seven days |
| Sterilization | Validated using ISO 11135:2014 | Sterilized by EO using conditions validated following ISO 11135:2014 |
| Physical Performance | Meets pre-defined acceptance criteria and intended use (general statement) | Meets the requirements of its pre-defined acceptance criteria and intended use (general statement) |
Missing: Specific quantitative acceptance limits for "physical performance" are not detailed. The criteria are largely based on meeting established ISO standards for biocompatibility and demonstrating comparable antibacterial activity to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "Modified ASTM E2149-13a was used to evaluate the antibacterial preservative activity of the subject device." However, it does not state the number of samples used in this testing.
- Data Provenance: The antibacterial testing was likely conducted in a lab environment in China by Huizhou Foryou Medical Devices Co., Ltd., given the manufacturer's location. The document does not specify if the testing involved human data or was purely laboratory-based. Given the nature of the device (dressing) and the tests mentioned (biocompatibility, antibacterial activity), it's highly probable these are laboratory tests, not human trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. This document describes laboratory performance testing (biocompatibility, antibacterial activity), not a clinical study requiring expert ground truth for a test set.
4. Adjudication method for the test set
- Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple experts. This document describes laboratory testing against established standards, not human interpretation.
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 device is a wound dressing, not an AI-powered diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used
- For Biocompatibility: Defined by ISO standards (ISO 10993-5, 10993-10, 10993-11). The "ground truth" is adherence to these normative documents.
- For Antibacterial Activity: Defined by the ASTM E2149-13a standard and achieving a specified log reduction (>4 log reduction) over a specific duration (seven days). This is a laboratory-based 'ground truth.'
8. The sample size for the training set
- Not applicable. This document describes a physical medical device (wound dressing) and its performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for a machine learning model is involved.
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