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InterDry Textile with Silver is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile with Silver reduces microbial colonization in the fabric.

Interdry Textile with Silver is a non-sterile skin protectant comprised of polyester knit textile substrate indicated for management of skin folds and other skin-to-skin contact areas and is offered as a 25.4 cm x 365.8 cm fabric piece, although other sizes may be available. The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Interdry Textile with Silver is a single patient use product that is custom cut from a multiuse package.

The provided text describes a 510(k) summary for the "Interdry Textile with Silver" device, which is a skin protectant. The performance testing section mentions "Biocompatibility testing" and "Antimicrobial testing". However, it does not provide detailed acceptance criteria with specific numerical targets, nor does it present a detailed study with a defined sample size, ground truth, or statistical analysis in the way typically expected for an AI/ML device.

It's important to note that K061615 is for a medical textile, not an AI/ML device. Therefore, the questions about AI/ML specific criteria (e.g., test set sample size, experts for ground truth, MRMC study, training set size) are not applicable to this submission. The "study" mentioned here refers to standard biocompatibility and antimicrobial efficacy tests for a medical textile.

Here's an attempt to answer the questions based on the available information, noting the limitations due to the nature of the device:

Acceptance Criteria and Device Performance for Interdry Textile with Silver (K061615)

This 510(k) submission is for a medical textile, not an AI/ML device. Therefore, many of the requested details, particularly those related to machine learning model evaluation, are not applicable. The reported performance relates to the physical and biological characteristics of the textile.

1. A table of acceptance criteria and the reported device performance

Note: Specific numerical acceptance criteria for biocompatibility and antimicrobial tests are not provided in this summary. These would typically be detailed in the full submission, referencing standards like ISO 10993 for biocompatibility and specific microbiological test standards.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. For biocompatibility tests, sample sizes are dictated by the specific ISO 10993 test methods (e.g., animal tests, in-vitro cell cultures). For antimicrobial testing, sample sizes are typically small, involving various microbial strains and replicates.
• Data Provenance: Not explicitly stated but inferred to be laboratory-generated data from testing performed to industry standards. This is likely prospective testing conducted in controlled environments. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable to this type of device. "Ground truth" in the context of biocompatibility and antimicrobial testing is established by standard laboratory protocols and expert interpretation of results, not by a consensus of medical experts reviewing patient data. The "experts" would be the scientists and toxicologists performing and interpreting the laboratory tests according to established scientific principles and standards.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical outcome or image interpretation studies. For laboratory tests, results are interpreted based on predefined criteria in the test standard, often without external adjudication beyond internal quality control and peer review of results.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• Ground Truth for Biocompatibility: Established by adherence to standardized testing protocols (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation) and comparison against established biological reactivity scales. The "truth" is whether the material elicits a harmful biological response above acceptable thresholds.
• Ground Truth for Antimicrobial Efficacy: Established by quantitative microbiological assays that measure the reduction in microbial counts when in contact with the material, compared to control samples. The "truth" is the measured inhibition or kill rate of specific microorganisms.

8. The sample size for the training set

• Not applicable. There is no AI/ML model to train for this device.

9. How the ground truth for the training set was established

• Not applicable. There is no AI/ML model to train for this device.

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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.

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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