(287 days)
The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. The dressing is also intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device: "Acutek Hydrocolloid Wound Dressing, TIB 197012". It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
- Details on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval notice, confirming that the device is substantially equivalent to a predicate device based on its intended use and general controls, rather than a detailed technical study report.
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