(252 days)
Cavilon™ Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon™ Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin.
3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacylate is dispersed in a non-stinging solvent. The film is colorless and non-cytotoxic. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.
The provided text describes the 3M™ Cavilon™ Advanced Skin Protectant, a Class I liquid bandage. However, it does not contain information related to a study that establishes acceptance criteria for an AI/ML powered device, nor does it report on the performance of such a device against those criteria.
The document is a 510(k) premarket notification summary for a physical medical device (skin protectant). It outlines the device's description, indications for use, comparison to predicate devices, and performance data from biocompatibility, bench, and clinical studies.
Therefore, I cannot provide the requested table and study details about AI/ML device acceptance criteria and performance based on the input document.
To directly answer the specific points you requested, based on the provided document:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes general performance data for a physical skin protectant (biocompatibility, durability, wash-off resistance), not AI/ML performance metrics.
- Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The clinical studies mentioned healthy subjects, but specific sample sizes are not provided in this summary for the "durability study" or the "wash off resistance study."
- Data Provenance: The document does not specify the country of origin of the data. The studies are described as "Controlled, randomized open label durability study on healthy subjects" and "Prospective, open label wash off resistance study on healthy subjects," indicating they were prospective clinical studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable and therefore not present. The studies are evaluating the physical properties and effectiveness of a skin protectant on human skin, not an AI's diagnostic or predictive capabilities requiring expert-established ground truth.
- Adjudication method for the test set: This information is not applicable and therefore not present.
- 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 information is not applicable and therefore not present. The device is a physical skin protectant, not an AI/ML diagnostic or assistive tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable and therefore not present. The device is a physical skin protectant.
- The type of ground truth used: For the clinical studies, the "ground truth" would likely be direct observation of skin condition, barrier effectiveness, and durability, potentially through clinical assessments by healthcare professionals or physical measurements, but this is not detailed in the summary. For the biocompatibility and bench tests, ground truth is established by standardized laboratory testing methods and measurements.
- The sample size for the training set: This information is not applicable and therefore not present, as the device is not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: This information is not applicable and therefore not present.
§ 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.