(374 days)
Prescription Use:
Sterile Silver Alginate Wound Dressing (Rx only) 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:
Sterile Silver Alginate Wound Dressing (OTC) is first aid to help in minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
Sterile Silver Alginate Wound Dressing is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent. This highly absorbent dressing vertically 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 and allows intact removal. Based on in-vitro testing, the silver in the dressing inhibits bacterial growth in the dressing for up to seven days. No clinical benefit has been demonstrated regarding the antibacterial effectiveness of the silver component.
The provided document is a 510(k) Summary for a Sterile Silver Alginate Wound Dressing. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to adherence to specific standards and conducted tests, implying that the acceptance criteria are defined by these standards and the device's ability to successfully meet them.
| Acceptance Criteria (Implied by Standards/Tests) | Reported Device Performance |
|---|---|
| Material Composition | Subject Device: Calcium alginate, Carboxymethylcellulose sodium, Silver sodium zirconium hydrogenphosphate. Predicate Device: Alginate and silver. (Not an explicit performance metric, but a characteristic compared.) |
| Antibacterial Duration | Subject Device: 7 days. Predicate Device: 7 days. |
| Single Use | Subject Device: Yes. Predicate Device: Yes. |
| Biocompatibility (per ISO 10993-1 for breached/compromised surfaces with prolonged contact (>24h to 30d)) | Tests Conducted (Subject Device): Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Subacute systemic toxicity, Implantation, Material-mediated pyrogenicity. Reported Performance: "demonstrate the device is as safe as its predicate device." (Implies meeting the criteria for each of these tests, but specific results are not detailed in this summary). |
| Sterilization (Gamma Irradiation, SAL: 10-6) | Subject Device: Gamma Irradiation, SAL: 10-6. Predicate Device: Radiation, SAL: 10-6. |
| Free Swell Absorption Capacity | Subject Device: 15.7 g/g. Predicate Device: 14.2 g/g. (Subject device's absorption is higher, exceeding predicate). |
| Liquid Absorbency (per EN 13726-1-2002) | Reported Performance: "The test results demonstrated that the Sterile Silver Alginate Wound Dressing complies with the following standards." (Implies successful adherence to the standard's requirements, specific metrics not detailed). |
| Loss on Drying (per USP ) | Reported Performance: "The test results demonstrated that the Sterile Silver Alginate Wound Dressing complies with the following standards." (Implies successful adherence to the standard's requirements, specific metrics not detailed). |
| pH Value (per USP pH) | Reported Performance: "The test results demonstrated that the Sterile Silver Alginate Wound Dressing complies with the following standards." (Implies successful adherence to the standard's requirements, specific metrics not detailed). |
| Antimicrobial Efficacy (per AATCC 100-2019) | Reported Performance: "The test results demonstrated that the Sterile Silver Alginate Wound Dressing complies with the following standards." (Implies successful adherence to the standard's requirements, specific metrics not detailed). |
| Minimum Bacteriostatic Concentration Test (per AATCC 100-2019) | Reported Performance: "The test results demonstrated that the Sterile Silver Alginate Wound Dressing complies with the following standards." (Implies successful adherence to the standard's requirements, specific metrics not detailed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for any of the performance bench tests. The document only mentions that tests were "conducted to verify that the proposed device met all design specifications." For biocompatibility, it states "the subject device was evaluated for" the listed tests, but does not provide numbers of samples or animals used.
- Data Provenance: Not specified. The submission is from Qingdao Bright Moon Biomedical Materials Co., Ltd. in China, suggesting the testing likely occurred in China, but this is not explicitly stated. The document indicates these are "non-clinical performance tests," implying they are laboratory/bench tests, not human data. It is inherently retrospective as the tests were completed prior to submission.
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)
- Not Applicable. This document describes the evaluation of a medical device (wound dressing) through non-clinical performance and biocompatibility testing. It does not involve diagnostic image analysis or clinical assessments that would require expert human interpretation to establish ground truth. The "ground truth" for these tests is defined by the physical or biological outcomes as measured by the testing protocols per the cited standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. As with point 3, this type of adjudication method is used for clinical studies or studies involving human readers/interpreters, which is not the case here. The results of the non-clinical tests are direct measurements or observations based on established protocols.
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
- No. This is not an AI-enabled diagnostic device and no MRMC study was conducted or is applicable. The document explicitly states: "No clinical study is included in this submission."
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical performance tests is defined by the metrics and acceptance criteria outlined in the cited international and national standards (e.g., EN 13726-1-2002 for liquid absorbency, USP for Loss on Drying, USP for pH Value, AATCC 100-2019 for Antimicrobial Efficacy and MBC, and ISO 10993 for biocompatibility). The device's performance is compared against these scientifically established benchmarks.
8. The sample size for the training set
- Not applicable. This device is a physical wound dressing, not an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, there is no corresponding ground truth establishment process for a training set.
N/A