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Prescription Use: SilverStream Gel 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.
OTC Use: SilverStream Gel is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.

SilverStream Gel is a clear hypertonic, non-pyrogenic liquid gel, designed for the 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, minor skin irritations, minor cuts, minor burns, abrasions and irritated areas. The action of SilverStream Gel is achieved by moisturizing wounds and maintaining wound moisture between dressing changes. A maintaining of the moist environment in the wound has been shown to be conducive to wound healing. Silver, serves as a preservative which, based on in vitro testing, inhibits the growth of microorganisms within the product during the shelf storage. The SilverStream Gel is supplied in 60mL polyethylene terephthalate (PETG) bottles. A pump head for dispensing is also supplied.

Here's an analysis of the provided text regarding the acceptance criteria and study proving a device meets these criteria:

Based on the provided K200767 document for SilverStream Gel, direct information on specific acceptance criteria for a device performance study and the detailed results of such a study are not explicitly presented in the format of a typical clinical trial or performance study report. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SilverStream®) through various tests and comparisons.

The document highlights the following:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a direct table linking specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for a clinical performance study and the device's reported performance against those criteria.

However, the "Performance Data" section describes categories of tests performed and the general outcome:

Key takeaway: The "acceptance criteria" here are largely implied by meeting "specifications" for various physical, chemical, and biological properties, as well as demonstrating safety and efficacy in general terms for biocompatibility. There are no quantitative performance metrics for a specific clinical outcome provided against pre-defined thresholds.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify sample sizes for individual tests. For example, it mentions "representative samples" for bench testing and does not quantify the number of animals used in the porcine wound healing study or the rat study. It also doesn't refer to any human test set in the context of an AI/algorithm.
• Data Provenance: Not specified beyond the types of tests (bench, biocompatibility, shelf life). There's no mention of country of origin of data or whether it was retrospective or prospective, as these are typically relevant for clinical studies, not the types of tests described here.

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 the document does not describe a study involving human interpretation of data where "ground truth" would be established by experts. The studies mentioned are laboratory-based and animal studies, where the "ground truth" is determined by the experimental setup and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable as there is no human-involved "test set" and thus no need for an adjudication method.

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 is not applicable. The device (SilverStream Gel) is a wound dressing, not an AI/imaging device that would be subject to MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. SilverStream Gel is a material-based medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the studies mentioned:

• Bench Testing: Ground truth is established by chemical analysis, microbiological assays, and physical property measurements against pre-defined specifications.
• Biocompatibility Testing: Ground truth is established by histological examination, clinical observation (in animal models), and various cellular/molecular assays conducted by toxicologists and pathologists according to standardized protocols (ISO 10993-1).
• Shelf Life Testing: Ground truth is established by physical inspection, chemical analysis, and microbiological testing against pre-defined stability specifications.

8. The sample size for the training set:

This is not applicable. There is no "training set" as SilverStream Gel is not an AI/machine learning device.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above.

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