(57 days)
Prescription Use: SilverStream is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations
Over-The-Counter Use: DermaSept is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas
The SilverStream (prescription), and DermaSept (OTC) Solutions, are clear, hypertonic aqueous solutions designed for the management and moisturizing of the application site by the action of the fluid moving across the wound bed. The product is hypertonic and contains a surfactant. The SilverStream, and DermaSept, Solution contains an antimicrobial ionic silver, as a preservative, which has been shown, by in vitro testing, to inhibit the growth of microorganisms such as Eschericha coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae Pseudomonas aeruginosa, Candida albicans and Aspergillus niger.
Here's an analysis of the provided text regarding the acceptance criteria and study information for SilverStream and DermaSept:
Summary of Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria for a novel performance claim. The key acceptance criteria revolve around:
- Similar intended use and indications for use.
- Substantially similar technological characteristics, including principles and mode of operation.
- Safety and performance demonstrated through in vitro and in vivo biocompatibility tests.
- Inhibition of microorganism growth (as a preservative).
The reported device performance confirms these criteria, stating that:
- The SilverStream/DermaSept has a similar intended use and indications for use as the predicate devices.
- It has substantially similar technological characteristics, including being a solution that moves across the wound surface (flushing).
- It contains an antimicrobial ionic silver as a preservative, shown by in vitro testing to inhibit the growth of several common microorganisms (Escherichia coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger).
- In vitro and in vivo biocompatibility tests were performed to demonstrate safety and performance, and the available data suggested "no new issues of safety and effectiveness."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal for Equivalence) | Reported Device Performance |
|---|---|
| Intended Use / Indications for Use: Similar to predicate devices. | Met: "The SilverStream labeled for prescription use, has a similar intended use and the same indications for use as the predicates... The DermaSept, labeled for OTC use, also has a similar intended use and indications for use as its predicates." |
| Technological Characteristics: Substantially similar to predicate devices (principles, mode of operation). | Met: "The SilverStream, and DermaSept, has substantially similar technological characteristics, including principles and mode of operation, to the predicate devices. Primarily, in similarity to the predicate devices, the SilverStream and DermaSept, is a solution that moves across the wound surface (flushing)." |
| Antimicrobial Activity: Contains an antimicrobial agent that inhibits growth of microorganisms (as a preservative). | Met: "The SilverStream, and DermaSept, Solution contains an antimicrobial ionic silver, as a preservative, which has been shown, by in vitro testing, to inhibit the growth of microorganisms such as Eschericha coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae Pseudomonas aeruginosa, Candida albicans and Aspergillus niger." |
| Safety and Performance: Demonstrated through in vitro and in vivo biocompatibility tests, with no new safety/effectiveness issues. | Met: "A set of in vitro and in vivo biocompatibility tests were performed... The available performance data demonstrate substantial equivalence... and that there are no new issues of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "A set of in vitro and in vivo biocompatibility tests were performed." However, it does not provide details on the sample size used for these tests, nor the country of origin or whether the data was retrospective or prospective. The information is very high-level.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts or radiologists to establish ground truth for any test set. The evaluation focuses on laboratory (in vitro), animal (in vivo biocompatibility), and comparative analysis against predicate device claims.
4. Adjudication Method for the Test Set:
Given that there's no mention of experts or a human-led evaluation of image data or similar, there is no adjudication method provided or implied in this documentation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document describes a 510(k) submission for a wound dressing, not an AI or imaging device that would typically undergo an MRMC study. It does not involve human readers interpreting data with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable in the context of an AI algorithm. The antimicrobial activity was assessed in vitro, which could be considered an "algorithm only" type of test for the active ingredient's function, but it's not an AI algorithm.
7. The Type of Ground Truth Used:
- For antimicrobial efficacy: In vitro laboratory testing against specified microorganisms served as the basis for the claim of growth inhibition. This "ground truth" would be established by standard microbiological assays.
- For biocompatibility: In vitro and in vivo (animal) biocompatibility tests serve as the ground truth for safety and biological response. These tests typically follow standardized protocols (e.g., ISO 10993).
- For overall substantial equivalence: The "ground truth" is a comparison to the established characteristics and performance of the identified predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a passive wound dressing, not an AI/machine learning algorithm that requires a training set. The "testing" referred to is for product characteristics and biological safety.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no AI algorithm or training set, this question does not apply.
N/A