(197 days)
SuperSkin® helps to protect skin exposed to irritation from moisture such as sweat, urine, and digestive juices.
SuperSkin® can also be used on unbroken skin surfaces that are exposed to friction and shear.
Do not apply over broken skin.
SuperSkin® is a topically-applied skin protectant for use on unbroken skin. The patient applies between 2-4 drops of SuperSkin® to the intact skin. The liquid polymerizes to form a thin, flexible coating.
The provided document is a 510(k) summary for a skin protectant device called SuperSkin®. It describes the device, its intended use, and technological characteristics, as well as the types of data submitted to the FDA to demonstrate substantial equivalence to predicate devices. However, it does not explicitly detail specific acceptance criteria or a dedicated study report comparing its performance against such criteria. The document focuses on demonstrating that SuperSkin® provides equivalent performance to predicate devices in areas like moisture barrier, vapor penetration, shear protection, friction reduction, and chronic irritation.
Therefore, much of the requested information cannot be directly extracted from this document. I will fill in what can be inferred and state when information is not present.
Here's an attempt to answer the questions based on the provided text, while acknowledging limitations:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of explicit, quantified acceptance criteria in the format typically used for medical device performance studies alongside reported device performance. Instead, it states that the device provides "equivalent performance" to predicate products across several characteristics.
| Acceptance Criteria (Implied) | Reported (Equivalent) Device Performance |
|---|---|
| Biocompatibility (Appropriate for intended use) | Demonstrated appropriate biocompatibility and non-toxicity for its intended use; Biological testing performed satisfactorily in accordance with ISO 10993. |
| Non-toxicity (Appropriate for intended use) | Demonstrated appropriate biocompatibility and non-toxicity for its intended use. |
| Moisture Barrier Performance (Equivalent to predicate) | Provides equivalent performance in terms of moisture barrier to the predicate product. |
| Vapor Penetration Performance (Equivalent to predicate) | Provides equivalent performance in terms of vapor penetration to the predicate product. |
| Shear Protection Performance (Equivalent to predicate) | Provides equivalent performance in terms of shear protection to the predicate product; performance characteristics for friction reduction and moisture protection evaluated in a clinical model. |
| Friction Reduction Performance (Equivalent to predicate) | Provides equivalent performance in terms of friction reduction to the predicate product; performance characteristics for friction reduction and moisture protection evaluated in a clinical model. |
| Chronic Irritation (Equivalent to predicate) | Provides equivalent performance in terms of chronic irritation to the predicate product; product evaluated for safety in a chronic irritation setting. |
| Non-sterile aseptic application suitability | Product is intended for application to skin in a nonsterile aseptic format. (Implies performance supports this). |
| Bioburden (Acceptable levels) | Bioburden assays were performed. (Implies acceptable levels were found to support non-sterile aseptic application). |
Note: The "acceptance criteria" listed above are inferred from the technological characteristics and data submitted, which state the device "demonstrates appropriate..." and "provides equivalent performance..." to predicate devices. No specific quantitative thresholds are provided for these equivalency claims.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample size used for the clinical model for friction reduction, moisture protection, or chronic irritation. It only states these were "evaluated in a clinical model" or "in a chronic irritation setting."
- Data Provenance: The country of origin of the data is not specified. The study appears to be prospective, given it describes "clinical model" and "chronic irritation setting" evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned (e.g., chronic irritation setting, clinical model for friction reduction and moisture protection) do not describe an expert-based ground truth establishment process, nor the number or qualifications of any experts involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth for a test set. This type of detail is typically found in studies involving expert interpretation, which is not the primary focus of this 510(k).
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a physical skin protectant, not an AI-assisted diagnostic or interpretive tool.
- Effect size of human readers with/without AI: This is not applicable as the device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical product, not an algorithm. Its performance is inherent to its physical properties and interaction with the skin.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The term "ground truth" as typically understood in AI/imaging studies does not directly apply here. Instead, the performance evaluations relied on:
- ISO 10993 guidelines: For biological testing of medical materials (for biocompatibility and non-toxicity).
- Clinical model evaluations: For friction reduction and moisture protection.
- Chronic irritation setting: For safety and irritation potential.
These likely involved objective measurements based on established standards and clinical observation/assessment rather than expert consensus on interpretive data or pathology. Outcomes data specific to patients (beyond irritation assessment) are not mentioned.
8. The sample size for the training set
This is not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a physical device.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.