(384 days)
Prescription:
Silver Alginate Dressing (Prescription use) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC:
Antibacterial Alginate Wound Dressing (OTC use) is first aid to help in minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns.
It is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent. The dressing absorbs wound exudate and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The alginate material contains silver which inhibits bacteria growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Staphylococcus aureus, Bacillus subtilis, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus (VRE), Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae for up to seven days.
The provided document is a 510(k) summary for a medical device called "Silver Alginate Dressing / Antibacterial Alginate Wound Dressing." This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
The document explicitly states: "No clinical study is included in this submission."
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as no such clinical study was submitted or detailed in this document.
However, I can extract information related to non-clinical testing and comparison to a predicate device, which are the bases for this 510(k) clearance.
Here's an analysis of the provided text, focusing on the available information:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study with acceptance criteria for clinical performance is presented, I will summarize the non-clinical tests and the comparison to the predicate device as presented in the document.
| Non-Clinical Test/Characteristic | Acceptance Criteria (Implied by compliance with standard) | Reported Device Performance (K202982) | Comparison to Predicate (K172554) |
|---|---|---|---|
| Biocompatibility | Complies with ISO 10993-5, -6, -10, -11 | Complies with ISO 10993-5, -6, -10, -11 | Same |
| Seal Strength | Complies with ASTM F88/F88M-15 | Complies with ASTM F88/F88M-15 | Not explicitly compared |
| Seal Leaks | Complies with ASTM F1929-15 | Complies with ASTM F1929-15 | Not explicitly compared |
| Bacterial Endotoxins | Complies with USP | Complies with USP | Not explicitly compared |
| Antibacterial Duration | N/A (in vitro shown up to 7 days) | 7 days (in vitro protected against bacteria) | Same (7 days) |
| Free Swell Absorption Capacity | N/A (value compared to predicate) | 14.2 g/g | Similar (Predicate: 13.8 g/g) |
| Sterilization | N/A (SAL: 10^-6) | Gamma irradiation, SAL: 10^-6 | Same (Radiation, SAL: 10^-6) |
| Intended Use | N/A (comparison to predicate) | As stated for Rx and OTC applications | Same |
| Mechanism | N/A (comparison to predicate) | Alginate for absorption, silver for bacteria reduction | Same |
| Material | N/A (comparison to predicate) | Alginate and silver | Same |
| Single Use | N/A (comparison to predicate) | Yes | Yes |
Explanation: For a 510(k) submission, "acceptance criteria" for non-clinical tests are generally met by demonstrating compliance with recognized standards. The document states that "The test results demonstrated that the proposed device complies with the following standards," which implies that meeting these standards served as the acceptance criteria for those specific tests. For comparative characteristics, "acceptance" is based on demonstrating substantial equivalence to the predicate device, meaning the differences do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide details on sample sizes for the non-clinical tests (e.g., number of dressings tested for absorption capacity, or specific biological evaluation tests). It also does not specify the country of origin of the data or whether it was retrospective or prospective. The non-clinical tests are typically laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as no clinical study or expert-adjudicated test set is described. The "ground truth" for non-clinical tests is established by adhering to the methodology and results specified in the referenced international and national standards (e.g., ISO, ASTM, USP).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as no clinical study or expert-adjudicated test set is described.
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. The device is a wound dressing, not an AI-powered diagnostic or interpretive tool. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" is determined by the specific testing methodologies and measurable outcomes defined by international and national standards (e.g., ISO for biocompatibility, ASTM for packaging integrity, USP for endotoxins). For the antibacterial efficacy, it's based on in vitro laboratory testing demonstrating inhibition of bacterial growth within the dressing.
8. The sample size for the training set:
This information is not applicable as no AI/machine learning component or training set is mentioned for this device.
9. How the ground truth for the training set was established:
This information is not applicable as no AI/machine learning component or training set is mentioned for this device.
N/A