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TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following: Pressure sores (all stages) Venous ulcers Skin tears Second degree burns Donor and graft sites Acute wounds healing by secondary or primary intention Surgically debrided wounds

TIELLE * Hydropolymer Foam Dressing is made from a hydrophilic polyurethane polymer.

I am sorry, but a detailed description of acceptance criteria and a study proving a device meets them, as requested, is not possible to extract from the provided text. The document is a 510(k) summary for a medical device (TIELLE* Hydropolymer Foam Dressing).

Here's why the information cannot be extracted:

• Nature of 510(k) Summary: A 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance data in the format you've requested. It typically includes indications for use, device description, and a general statement about safety/biocompatibility, but not the specifics of a study proving performance against defined acceptance criteria.
• Missing Information:
  • The document states "Safety tests demonstrate that TIELLE* Hydropolymer Foam Dressing is non-sensitizing, and nonirritating and suitable for its intended use." However, it does not provide:
    • A table of acceptance criteria and reported device performance.
    • Details about the sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for any performance study.
    • Information about training sets or how ground truth for training sets was established.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence based on safety and intended use, not a clinical study report detailing performance against specific, quantitative acceptance criteria.

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