(488 days)
Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Modern Medical Antimicrobial Wound Dressing is made up of darker viscose polyester layer and a lighter layer of non-woven cloth. The darker layer contains nano silver ions (0.5 mg per g) about 1-100 nm in diameter, these provide a barrier protection against microbes. The lighter layer is designed to protect the wound surface. Modern Medical Antimicrobial Burn Dressing is totally made of unwoven cloth. The thicker and stronger texture also contains silver ions (2.6 mg per g) in order to form an effective barrier against microbes. It is intended to be applied directly onto the wound and cover with conventional methods.
The provided text describes the Modern Medical Antimicrobial Wound Dressing and Modern Medical Antimicrobial Burn Dressing. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria and device performance. Therefore, detailed information on acceptance criteria and a study proving device performance in the manner requested (e.g., sample sizes, expert qualifications, HRMC studies, standalone performance with ground truth) is not present in the provided document.
Instead, the document focuses on demonstrating the safety and effectiveness of the device through various performance tests and biocompatibility assessments rather than a direct clinical performance study comparing against specified acceptance criteria for diagnostic or treatment accuracy.
Here's an analysis of the provided information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| No cytotoxicity | Studies show dressings are safe. |
| No skin sensitization | Studies show dressings are safe. |
| No skin irritation | Studies show dressings are safe. |
| No acute toxicity | Studies show dressings are safe. |
| No mutagenicity (Ames Test) | Studies show dressings are safe. |
| No chromosomal aberration (In Vitro Mammalian Chromosome Aberration Test) | Studies show dressings are safe. |
| No gene mutation (In vitro Mammalian Cell Gene Mutation Test) | Studies show dressings are safe. |
| Antimicrobial Effectiveness: | |
| Effective against microbial contamination (barrier protection) | Antimicrobial Preservatives Effectiveness test based on USP 51 performed. |
| Antimicrobial activity demonstrated | Antimicrobial Activity Assessment of Antimicrobial Medical Dressing test using AATCCC Test Method 147 performed. |
| Material/Design Functionality: | |
| First aid management for minor abrasions, cuts, scrapes, scalds, and burns. | Devices function as first aid management. |
| Silver ions provide effective barrier against microbial contamination. | Silver ions (0.5 mg/g for Wound, 2.6 mg/g for Burn) provide barrier protection against microbes. |
Note: The document states "The studies show that the dressings, Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are safe and effective for their intended use." This is a general statement of compliance rather than specific quantitative performance metrics against pre-defined numerical acceptance criteria.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The performance assessments listed (biocompatibility and antimicrobial effectiveness tests) are typically laboratory-based tests. The document does not specify human clinical trial sample sizes or data provenance (country, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/not provided. The listed tests are laboratory assays (e.g., cytotoxicity, skin irritation, antimicrobial efficacy). These tests have defined protocols and endpoints according to standards (ISO, USP, AATCCC), and their results are interpreted by technical experts in those fields, but it's not a "ground truth" establishment in the sense of clinical expert consensus for image or diagnostic interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like "2+1" are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The listed tests are not set up in this manner.
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
This information is not applicable/not provided. This device is a wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a physical wound dressing and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance assessments are established by the pre-defined endpoints and methodologies of the international and national standards described:
- Biocompatibility: ISO 10993 (Parts 1, 3, 11) - These standards define methods for evaluating biological risks, and the "ground truth" is adherence to the safety limits and observations specified within these protocols (e.g., absence of cytotoxicity, irritation, sensitization).
- Antimicrobial Effectiveness: United States Pharmacopoeia (USP 51) and American Association of Textile Chemists & Colorists (AATCCC Test Method 147) - These standards prescribe specific bacterial or fungal challenge tests and measure the reduction in microbial population. The "ground truth" is meeting the specified reduction criteria defined in these standards.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. This device is not an AI algorithm that requires a training set or associated ground truth.
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