(23 days)
SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters and scalds.
SureSkin Silver bandages are sterile, single-use dressings that consist of silver -containing hydrocolloid adhesive bonded to an outer polyurethane film cover for an antimicrobial effect. The hydrocolloid adhesive is designed to interact with moisture from the skin and wound surface where it forms a gel and creates a moist wound environment that is known to speed the healing process faster than commonly used bandages Once the bandage begins to interact with moisture the silver in the adhesive is activated and helps to kill bacteria which are in direct contact with the dressing.
This is a 510(k) premarket notification for SureSkin Silver Bandage, which claims substantial equivalence to a predicate device. Therefore, a traditional acceptance criteria and study proving performance as one might expect for a novel device is not explicitly present in the provided document. The purpose of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device.
Instead of presenting an acceptance criteria table and a new clinical study to meet those criteria, the submission relies on demonstrating similarity to the predicate device and using non-clinical testing.
Here's a breakdown based on your request, focusing on what is provided and clarifying what is not:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not explicitly present in the 510(k) submission as it would be for a de novo device or a PMA application. For a 510(k), acceptance criteria are implicitly tied to demonstrating equivalence to the predicate device.
The document states: "Antimicrobial effectiveness and Microbial Barrier testing was performed on the predicate device and showed that it provides an effective microbial barrier in the dressing. Biocompatibility testing was performed. Test results demonstrated that the device is suitable for its intended use."
The current device, SureSkin Silver Bandage, is stated to be "identical in formulation, packaging materials and produced under same manufacturing processes to the predicate device." Therefore, the acceptance is based on the assumption that if the predicate device met these performance criteria, and the new device is identical, then the new device also meets them.
Summary of what's provided related to "performance":
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (by Equivalence) |
|---|---|
| Antimicrobial effectiveness | Effective antimicrobial barrier in the dressing (based on predicate testing) |
| Microbial Barrier | Provides an effective microbial barrier (based on predicate testing) |
| Biocompatibility | Suitable for its intended use (based on predicate testing) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. This documentation refers to "in vitro laboratory testing" for antimicrobial effectiveness on the predicate device. The specific numbers of test samples, if any in a clinical sense, are not detailed as this is a non-clinical submission relying on equivalence for a Class I/unclassified device.
- Data Provenance: The "in vitro laboratory testing" was done on the predicate device. No geographical information is provided, but it would have been conducted by or for the manufacturer (EuroMed Inc.). The data is retrospective in the sense that it relies on past testing of a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable or provided in this 510(k) submission. No human clinical studies or expert-driven test sets (e.g., for image interpretation or diagnosis) are described. The evaluation relies on laboratory testing and comparison to an existing device.
4. Adjudication Method for the Test Set
This is not applicable or provided. There is no "test set" in the context of human-interpreted data or clinical outcomes requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable or provided. This type of study is relevant for diagnostic devices involving human interpretation of results, often with AI assistance. The SureSkin Silver Bandage is a wound dressing, not a diagnostic device.
6. Standalone (Algorithm Only) Performance
This is not applicable or provided. The device is a physical wound dressing, not an algorithm. The "antimicrobial effectiveness" can be considered a standalone performance characteristic of the dressing itself, but it's not an algorithm's performance.
7. Type of Ground Truth Used
For the in vitro antimicrobial effectiveness testing on the predicate device:
- Antimicrobial effectiveness: Likely based on standard microbiological methods (e.g., zone of inhibition, reduction in bacterial count) against specific bacterial strains (Staph aureus (MRSA), E. coli, and P. aeruginosa). The "ground truth" would be the measured reduction in bacterial growth or killing.
- Microbial Barrier: Likely based on physical testing demonstrating the dressing's ability to prevent microbial penetration.
- Biocompatibility: This would involve standard toxicology and irritation tests, with "ground truth" being the absence of adverse biological reactions.
8. Sample Size for the Training Set
This is not applicable or provided. There is no "training set" as this is not an AI/machine learning device.
9. How Ground Truth for the Training Set Was Established
This is not applicable or provided.
In summary: The provided document is a 510(k) premarket notification for a wound dressing. Its "acceptance criteria" are demonstrating substantial equivalence to a predicate device, which includes having similar performance characteristics as proven by in vitro laboratory testing on the predicate device and the new device being identical in composition and manufacturing. There are no clinical studies, expert-adjudicated test sets, or AI algorithm evaluations described in this type of submission.
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