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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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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:

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.

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The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.

The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments. It is provided as a sterile, single-use, disposable device.

The provided text describes a 510(k) summary for a medical device (DermaStream™ occlusive wound dressing) but does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document focuses on:

• Device Identification: Name, classification, manufacturer, contact.
• Predicate Devices: Identifying similar legally marketed devices (KCI Wound Cell Transparent Wound Dressing, 3M Tegaderm Transparent Dressing, KCI V.A.C. Instillamat).
• Device Description: An occlusive wound dressing permitting topical wound treatment introduction, sterile, single-use, disposable.
• Intended Use: To provide a moist healing environment and allow debridement to facilitate normal wound healing.
• Technological Characteristics Comparison: Stating it is substantially equivalent to predicate devices, being a combination of their features, with the primary difference being solution/drainage provision via gravity vs. vacuum.
• FDA Correspondence: Confirming the substantial equivalence determination.

Therefore, I cannot provide the requested table or elaborations on the study details because the necessary information is not present in the provided text. The document is essentially a regulatory submission summary, not a performance study report.

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