(41 days)
Under the supervision of a healthcare professional, High Performance Antimicrobial Gelling Fiber with Silver can be used in the management of moderate to heavily exuding chronic and acute wounds. The antimicrobial dressing is indicated for use on the following wounds;
- · Pressure ulcers (partial and full thickness)
- · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- · Diabetic foot ulcers
- · Surgical wounds that heal by primary intent such as dermatological and surgical incisions
- · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
- Traumatic wounds
High Performance Antimicrobial Gelling Fiber with Silver is an antimicrobial, absorbent gelling fiber dressing comprising of a non-woven pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is sterile, soft and conformable to anatomical contours.
High Performance Antimicrobial Gelling Fiber with Silver manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. High Performance Antimicrobial Gelling Fiber with Silver can be used under compression.
High Performance Antimicrobial Gelling Fiber with Silver contains ionic silver, and effectively manages and suppresses colonization and proliferation of micro-organisms within the dressing for up to 7 days.
High Performance Antimicrobial Gelling Fiber with Silver, when tested in vitro, has been shown to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.
The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in²) to 650cm² (100.75 in²).
High Performance Antimicrobial Gelling Fiber with Silver is a modification of the predicate device to include updated product labelling in support of an antimicrobial product offering.
This document is a 510(k) premarket notification for a medical device called "High Performance Antimicrobial Gelling Fiber with Silver." It is a regulatory submission to the FDA, not a study report proving the device meets specific performance acceptance criteria through clinical or comparative effectiveness studies in the traditional sense of AI/imaging devices.
Therefore, many of the requested criteria for AI/imaging device studies (like sample size for test sets, number of experts for ground truth, MRMC studies, effect size, etc.) do not apply to this type of medical device clearance.
This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (Silver High Performance Dressing, K183645), primarily by showing that the new device has identical design, materials, and manufacturing processes, and similar performance characteristics. The key modification mentioned is updated product labeling to support an antimicrobial offering, which is backed by in vitro testing.
Here's a breakdown of the relevant information from the document in relation to your request, with an explanation of why other parts are not applicable:
1. A table of acceptance criteria and the reported device performance:
The document does not present a formal table of quantitative acceptance criteria for in vivo clinical performance metrics typically seen with AI algorithms (e.g., sensitivity, specificity, AUC). Instead, the "performance" demonstrated is primarily through in vitro testing and claims of substantial equivalence to the predicate.
| Acceptance Criteria (Implied for Antimicrobial Claim) | Reported Device Performance |
|---|---|
| Efficacy against micro-organisms (in vitro) | Effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing for up to 7 days. |
2. Sample sized used for the test set and the data provenance:
- Not applicable for clinical/human test sets. The performance data mentioned is from in vitro testing against microorganisms. No information is provided about the "sample size" of microorganisms or the specific provenance of the data beyond "in vitro."
- Retrospective/Prospective: The in vitro testing is a laboratory study, not a retrospective or prospective clinical study on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to the identification of microorganisms and their inhibition, which is established through standard microbiological laboratory methods, not expert human readers of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to human reader consensus in diagnostic studies, which is not relevant here.
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 MRMC study was done. This device is a wound dressing, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "standalone" performance here is the in vitro antimicrobial efficacy. The document states: "High Performance Antimicrobial Gelling Fiber with Silver, when tested in vitro, has been shown to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing." This is the primary standalone performance claim.
7. The type of ground truth used:
- Microbiological laboratory reference standards/assays for in vitro antimicrobial efficacy. For the wound healing and absorption claims, the ground truth is implied by the physical and chemical properties of the dressing, and its substantial equivalence to the predicate which had its own performance data for those aspects.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm that undergoes a "training set" process.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary:
This 510(k) submission for an antimicrobial wound dressing clears the device based on substantial equivalence to an existing predicate device and in vitro laboratory testing to support its antimicrobial claims. It does not involve the types of clinical or AI performance studies (e.g., diagnostic accuracy, human reader studies, ground truth established by expert consensus on images) that would require the detailed information requested in points 2-5, 8, and 9.
N/A