(183 days)
The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.
The CURAD® Silver Bandage is an adhesive bandage that includes silver in the wound pad. The bandage covers the wound to create a protected environment. At the same time, silver ions reduce bacterial growth in the wound pad.
The provided text describes a 510(k) premarket notification for the CURAD® Silver Bandage, which is an adhesive bandage containing silver in its wound pad. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
However, the provided document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it refers to general performance testing.
Here's a breakdown of the information presented, highlighting why a full acceptance criteria study cannot be extracted as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states:
| Criteria Category | Device Performance |
|---|---|
| Silver release | Acceptable results |
| Antimicrobial effect | Acceptable results |
| Biocompatibility | Satisfactory results |
- Missing Details: The document does not specify the quantitative or qualitative "acceptance criteria" for "acceptable" or "satisfactory" in terms of silver release, antimicrobial effect, or biocompatibility. It also does not provide the specific numerical results obtained during testing.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any of its performance testing.
3. Number of Experts and Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their qualifications. This is not typically part of a 510(k) submission for this type of device, which focuses on device performance rather than interpretation of complex medical images or data by experts.
4. Adjudication Method for the Test Set:
The document does not provide information on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key factor.
6. Standalone (Algorithm Only) Performance:
The document does not describe any standalone (algorithm only) performance. This device is a physical product, not an algorithm.
7. Type of Ground Truth Used:
For the performance testing mentioned (silver release, antimicrobial effect, biocompatibility), the "ground truth" would be established through laboratory testing and established scientific standards/methods for measuring these properties. The specific details of these methods are not provided in this 510(k) summary.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable to this physical medical device. This term is used for machine learning algorithms.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there is no "training set" for this device.
In summary, the provided 510(k) summary for the CURAD® Silver Bandage indicates that performance testing for silver release, antimicrobial effect, and biocompatibility was conducted and yielded "acceptable" or "satisfactory" results. However, it lacks the detailed quantitative acceptance criteria, specific study designs, sample sizes, and expert involvement that would be present in a comprehensive study report for certain types of medical devices, particularly those involving diagnostics or complex algorithms. The submission aims to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and general performance, rather than providing detailed clinical trial data with expert agreement and specific statistical metrics often seen for higher-risk devices or software as a medical device.
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