(344 days)
Under the supervision of a healthcare professional, the product is intended for the management and relief of burning, itching and redness associated with atopic dermatiis. The product, when applied topically to the affected area, forms a protective barrier.that tells. Ins keep the skin moist, which has a beneficial effect on the healing rooces of
Locobase® Wound and Skin Emulsion is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 30 g and 100g tubes.
This 510(k) summary (K060272) for Locobase® Wound and Skin Emulsion does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria. The submission is a "substantial equivalence" claim, meaning the device is compared to already legally marketed devices.
Here's an breakdown of the information that is and is not available in the provided text, based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states "Functional and performance testing has been conducted to assess the safety and efficacy of Locobase® Wound and Skin Emulsion," but it does not provide specific acceptance criteria or the results of this testing.
2. Sample Size Used for the Test Set and Data Provenance
Not available. The document does not describe a test set, sample size, or data provenance from a specific study for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available. There is no mention of a test set or expert involvement in establishing ground truth.
4. Adjudication Method for the Test Set
Not available. There is no mention of a test set or adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not available. The document does not describe an MRMC study or any comparative effectiveness data with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a topical emulsion, not an algorithm or AI.
7. The Type of Ground Truth Used
Not applicable. For a medical device like this emulsion, "ground truth" typically refers to the clinical outcomes and safety profiles observed in human subjects. The document states that "Functional and performance testing has been conducted to assess the safety and efficacy," implying that clinical evaluations or similar studies would have assessed the product's effect on symptoms (burning, itching, redness) associated with atopic dermatitis, though no details are provided.
8. The Sample Size for the Training Set
Not applicable/available. This device is a topical emulsion, not an AI model requiring a training set. If "training set" refers to participants in a clinical trial, this information is not provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable/available. As it's not an AI device, there's no "training set" in that sense. If the "training set" refers to subjects in a clinical study, the method for establishing "ground truth" (i.e., efficacy and safety endpoints) would typically involve clinical assessments by healthcare professionals, patient-reported outcomes, and possibly objective measures of skin condition. However, these details are not provided in the 510(k) summary.
Summary of Device and Approval:
The K060272 submission is for Locobase® Wound and Skin Emulsion. It states that the device is "similar in composition, function and intended use" to several predicate devices already on the market (Biafine™ Wound Dressing Emulsion, Sinclair (Atopiclair™) Wound and Skin Emulsion, and MimyX™ Cream). The FDA's letter confirms a "substantial equivalence" determination, allowing the device to be marketed. This type of submission relies on demonstrating similarity to existing devices rather than presenting extensive de novo clinical trial data with specific acceptance criteria in the 510(k) summary itself. The phrase "Functional and performance testing has been conducted to assess the safety and efficacy" indicates that some level of testing was performed, but the results and methodologies are not detailed in this public summary.
N/A