(81 days)
The Milliken Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. Milliken Silver Wound Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
Milliken's Silver Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressing consists of a nylon, lycra, and polyester continuous filament Jersey knit textile substrate which is pad coated with an aqueous suspension of silver sodium hydrogen zirconium phosphate (AlphaSan® RC-2000) and a polyurethane binder to provide an antimicrobial coating to the fabric. The textile substrate has a nylon face and polyester back providing a moisture affinity gradient across the thickness of the dressing.
Milliken Silver Wound Dressings are offered in several configurations including the following: 2" x 2", 4.25" x 4.25", 6" x 6", 1" x 24" and 4" x 48" (wrap).
Here's an analysis of the provided text regarding the Milliken Silver Wound Dressings, structured according to your request. Please note that the document is a 510(k) summary for a medical device cleared by the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance against predefined acceptance criteria through a full-fledged clinical study in the way a novel drug or a high-risk AI algorithm might.
This document describes a wound dressing, which is a relatively low-risk device. The "performance testing" described is primarily to support the claim of substantial equivalence and safety, not to establish a precise performance metric like sensitivity or specificity.
Acceptance Criteria and Study Details for Milliken Silver Wound Dressings
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a wound dressing, the "acceptance criteria" are not framed as specific numerical performance targets like sensitivity/specificity for an AI algorithm. Instead, the acceptance criteria are implicitly that the device is substantially equivalent to legally marketed predicate devices, demonstrating comparable safety and effectiveness.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility: Suitable for intended use (non-toxic, non-irritating). | Results: Biocompatibility testing performed in accordance with ISO recommendations demonstrated the device is suitable for its intended use. Specifically, the animal study indicated the test articles were "nonirritant as compared to the negative and comparative controls." |
| Antimicrobial Barrier Effectiveness: Provides an effective microbial barrier to the dressing itself. | Results: Antimicrobial testing performed showed that the Milliken Wound Dressings provide an effective microbial barrier to the dressing itself. This aligns with the intended use statement: "provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing." The document references "zone-of-inhibition antimicrobial" testing, which is a standard method to demonstrate antimicrobial activity of substances. |
| Wound Healing Characteristics: Does not impede normal wound healing. | Results: A full thickness wound healing study conducted using swine found that "All wounds appeared to heal without complication." Microscopically, "the test articles were considered nonirritant as compared to the negative and comparative controls." This indicates that the dressing did not negatively impact the healing process and was well-tolerated. |
| Substantial Equivalence: Design, function, and intended use are similar to predicate devices, and differences do not affect safety and effectiveness. | Claim: Milliken believes that the data, including technical characteristics, physical properties, silver extraction, zone-of-inhibition antimicrobial and animal testing, demonstrates substantial equivalence to Argentum Medical LLC Silverlon® Wound Contact Dressing (K023612) and Westaim Biomedical Acticoat™ 7 Dressing (K001519). The FDA ultimately concurred with this claim, issuing the 510(k) clearance (K051445). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Biocompatibility: Not specified beyond "testing was performed."
- Full Thickness Wound Healing Study (Swine): The specific number of swine or wounds is not explicitly stated. It mentions "swine in order to characterize the healing process."
- Antimicrobial Testing (Zone-of-Inhibition): Not specified.
- Data Provenance: The wound healing study was conducted using swine (animal data). Other tests (biocompatibility, antimicrobial) are general lab tests. There is no human clinical data presented in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Experts: Not explicitly mentioned in the context of establishing "ground truth" for the test results. For the animal study, the microscopic evaluation of irritation would typically be performed by a veterinary pathologist, but their number and qualifications are not specified nor is it described as "ground truth" in the AI sense.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This document does not describe a process involving human judgment on diagnostic output, but rather laboratory and animal study results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed or described. This type of study is typically relevant for diagnostic imaging or AI algorithms where human readers interpret results.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Standalone Performance: Not applicable. The device is a physical wound dressing, not a diagnostic algorithm. Therefore, "standalone performance" in the context of AI is not relevant. The device implicitly performs its function (antimicrobial barrier, wound healing support) "standalone" without human-in-the-loop interaction for its primary function once applied.
7. Type of Ground Truth Used
- Ground Truth: The "ground truth" here is based on biological outcomes (wound healing, non-irritation) and laboratory measurements (antimicrobial activity, biocompatibility metrics).
- For the wound healing study: The observation that "All wounds appeared to heal without complication" and microscopic findings that "the test articles were considered nonirritant" serve as the "ground truth" for the dressing's impact on healing in the animal model.
- For antimicrobial activity: The "zone-of-inhibition" results directly measure the antimicrobial efficacy, serving as ground truth for that specific property.
- For biocompatibility: The results from ISO-compliant tests establish the biological safety.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for a physical wound dressing.
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