(88 days)
Low Adherent AFM Ag 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). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.
The provided text does not describe a study that proves the device meets specific acceptance criteria in the context of typical medical device performance studies for diagnostic or therapeutic efficacy.
Instead, this document is a 510(k) Summary for a wound dressing, which focuses on substantial equivalence to a previously cleared predicate device. The "performance testing" mentioned is for validation activities rather than a comparative effectiveness or standalone performance study in the way one might expect for a diagnostic AI device.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not applicable or cannot be extracted from this specific document.
Here's an attempt to answer the questions based on the available information, highlighting where the information is missing or not relevant to the requested structure:
Acceptance Criteria and Device Performance Study for Low Adherent AFM Ag Dressings
The provided 510(k) Summary for the Low Adherent AFM Ag Dressings describes validation activities to support the modified device, rather than a study with explicit acceptance criteria and device performance metrics as would typically be presented for a diagnostic or AI-driven device.
The core of this submission is to demonstrate substantial equivalence to a predicate device (Milliken Silver Wound Dressing, K051445) and to confirm that the modification (addition of a low adherent wound contact layer) does not affect safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance / Validation Achieved |
|---|---|---|
| Biocompatibility | Not explicitly stated | Biocompatibility Testing was conducted. |
| Antimicrobial Effectiveness | Not explicitly stated, but inferred from predicate device's claims | Validation of Antimicrobial Effectiveness was conducted. The device is effective antimicrobial barrier against Gram-positive and Gram-negative bacteria, including MRSA, MRSE, VRE, Pseudomonas aeruginosa, and Acinetobacter baumannii. |
| Sterility | Not explicitly stated | Sterility Validation was conducted. |
| Overall Performance | Fulfill prospectively defined performance criteria; modified system meets user needs (post-modification). | "Testing... has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modified system meets user needs." |
| Substantial Equivalence | Device is identical to predicate except for low adherent layer; modification does not affect safety and effectiveness. | FDA found the device to be substantially equivalent to the predicate device K051445. |
Missing Information: Precise quantitative acceptance criteria (e.g., specific cytotoxicity thresholds, minimum microbial reduction percentages, or sterility assurance levels as defined in standards) are not detailed in this summary. The "reported device performance" is described qualitatively as "validation conducted" and meeting "prospectively defined performance criteria."
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of a performance study for a diagnostic or therapeutic effect. The validation activities (biocompatibility, antimicrobial effectiveness, sterility) typically involve standardized laboratory tests, for which sample sizes are determined by the specific test methods and regulatory standards (e.g., ISO, ASTM). The document does not provide these sample sizes or data provenance (country, retrospective/prospective) for these lab tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The validation activities for a wound dressing (biocompatibility, antimicrobial effectiveness, sterility) do not involve expert-established "ground truth" in the way a diagnostic imaging study would. Standardized laboratory methods and controls are used.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication is described or relevant for these types of validation tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC comparative effectiveness study is not relevant for a wound dressing and was not conducted or mentioned in this 510(k) summary. This type of study is typically for diagnostic devices, especially those involving human interpretation of data (e.g., radiology AI).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical wound dressing, not an algorithm or AI system.
7. The Type of Ground Truth Used
The concept of "ground truth" as pathology or outcomes data is not directly applicable here. For the described validation activities:
- Biocompatibility: Ground truth is established by standardized material safety tests and comparison to established safe materials or acceptable toxicity limits (e.g., ISO 10993 standards).
- Antimicrobial Effectiveness: Ground truth is established by laboratory cultures and validated methods for measuring microbial reduction or inhibition (e.g., ATCC strains, established protocols).
- Sterility: Ground truth is established by validated sterilization processes and sterility testing (e.g., USP guidelines, ISO 11137).
8. The Sample Size for the Training Set
Not applicable. This device is a physical wound dressing and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
Summary of Device Rationale from the Document:
The 510(k) describes a modification to an already cleared predicate device (Milliken Silver Wound Dressing K051445). The modification is the "addition of a low adherent wound contact layer." The key argument for substantial equivalence is that this modification is "minor and does not affect safety and effectiveness of the device." The "performance testing" (biocompatibility, antimicrobial effectiveness, sterility validation) was conducted to confirm that the modified device continues to meet expected performance criteria, implying these tests re-verified the properties of the device post-modification without necessarily presenting a new comparative efficacy study.
N/A