(272 days)
It is intended for use as primary or secondary dressings for exuding wounds,surgical incisions, abrasions, first and second degree burns, wound packing, donor sites, catheter sites, I. V. sites and central lines. Also may be used for securement of primary dressing. The antimicrobial activity of the PHMB and benzalkonium chloride in dressing helps resist bacterial colonization within the dressing.
The proposed devices are available in three configurations, which are Antimicrobial gauze sponge dressing. Antimicrobial super sponge dressing and Antimicrobial non-woven sponge dressing. All of them consist of (1) a dressing (base material) and (2) anti-microbial agent. For each configuration, it is available in several models, which are different in size and quantity of anti-microbial agent.
The product can achieve board spectrum antimicrobial effect within the dressing for Gram-Bacteria and Fungi. It has been shown to have 4 log bacterial reduction in vitro against includes: Staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomona aeruginosa and Bacillus subtilis, Streptococcus pyogenes, Serratia marcescens, Aspergillus niger. The effective inhibition of bacteria within the dressing is 7 days.
The provided text is a 510(k) Summary for a medical device (Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing). It describes a submission to the FDA seeking clearance based on substantial equivalence to a predicate device.
The document does not describe a study conducted to prove the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would. Instead, it focuses on non-clinical tests to demonstrate compliance with standards and substantial equivalence to a predicate device.
Therefore, many of the requested categories for the acceptance criteria and study that proves the device meets them cannot be answered from this document because they are not applicable to the type of submission described (a 510(k) for a dressing, not an AI/ML diagnostic device). Specifically, there is no mention of an algorithm, AI, human readers, ground truth establishment for a test set, or training set details.
However, I can extract information related to the acceptance criteria as described by standard compliance and the comparison to the predicate device.
Here's a breakdown of the information that can be extracted or deduced from the provided document, addressing the structure of your request where applicable, and indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the format of a clinical performance target (e.g., sensitivity/specificity thresholds) or a statistical endpoint for a trial. Instead, the "performance" discussed is compliance with established standards and similar characteristics to a predicate device.
| Acceptance Criteria Category/Standard | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) | Complies with ISO 10993-5 (Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity) |
| ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization) | Complies with ISO 10993-10 (Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization) |
| ISO 10993-6:2016 (Tests for local effects after implantation) | Complies with ISO 10993-6 (Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation) |
| ISO 10993-11:2006 (Tests For Systemic Toxicity) | Complies with ISO 10993-11 (Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity) |
| Sterilization Residuals: | |
| ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals) | Complies with ISO 10993-7 (Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals) |
| Packaging Integrity: | |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Complies with ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials) |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Complies with ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) |
| Bacterial Endotoxins: | |
| USP Bacterial Endotoxins Test | Complies with USP Bacterial Endotoxins Test |
| Antimicrobial Activity (in vitro): | Achieved 4 log bacterial reduction in vitro against: Staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomonas aeruginosa, Bacillus subtilis, Streptococcus pyogenes, Serratia marcescens, Aspergillus niger. Effective inhibition within dressing for 7 days. |
| In vitro bacterial reduction (e.g., 4 log reduction against specific organisms) | |
| Sterility Assurance Level (SAL): | SAL of 10^-6 |
| Sterility Assurance Level | |
| Substantial Equivalence to Predicate Device (K160872): | Demonstrated Substantially Equivalent (SE) for: Product Code (FRO), Regulation Number (NA), Intended Use (similar wound types, antimicrobial activity), Single Use (Yes), Antimicrobial Agents (PHMB, Benzalkonium chloride/BZK), and Biocompatibility (ISO 10993). |
| Equivalence in Product Code, Regulatory Number, Intended Use, Single Use, Active Agents, Material, Sterilization method, Biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided as there was no "test set" in the context of an algorithm or diagnostic performance study. The studies mentioned are non-clinical lab tests for material properties, sterilization, and biocompatibility. Details like sample sizes for these specific lab tests are generally found in the full test reports, which are not part of this summary document. Data provenance details are also not stated for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. There was no "ground truth" to be established by experts for a diagnostic performance test, as this device is a wound dressing and not a diagnostic AI/ML tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. No adjudication method was used for a test set, as this is not a diagnostic device.
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 and not provided. No MRMC study was performed as this is a medical device clearance for a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. There is no algorithm associated with this wound dressing device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. There was no "ground truth" established in the context of diagnostic performance. The "truth" for this device's performance comes from compliance with recognized standards (e.g., ISO, ASTM, USP) and laboratory assays for antimicrobial activity.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for this device, as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" for this device, as it is not an AI/ML algorithm.
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