(85 days)
TALIDERM™ is intended for use under the direction of a healthcare professional.
TALIDERM™ is indicated for the management of wounds including: Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.
TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.
This document is a 510(k) summary for a medical device called TALIDERM™, a wound dressing. It declares substantial equivalence to predicate devices based on biocompatibility and performance characteristics. However, it does not include detailed acceptance criteria or a study that proves the device meets those criteria, as typically found in clinical trial reports for devices that require them.
Here's an analysis of why the requested information cannot be fully provided based solely on the provided text, and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria or quantitative performance metrics for TALIDERM™. Instead, it states:
- "Results of scientific testing have ensured that the material is biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
- "Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted."
- "Clinical evidence further supported the safety and performance of TALIDERM™."
These are general statements affirming that testing was done and the outcomes were positive, but they do not define specific, measurable acceptance criteria (e.g., "wound closure rate > X%", "infection rate
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