(119 days)
Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin.
Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have.
Hydrofera BacteriostaticWound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, díabetic ulcers, abrasions, lacerations, superficial burns, post surgical incisions, and other external wounds inflicted by trauma.
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This document is a 510(k) premarket notification letter from the FDA regarding the Hydrofera Bacteriostatic Wound Dressing. It declares substantial equivalence to a predicate device and outlines regulatory compliance. However, it does not contain the specific information required to answer your questions about acceptance criteria and study details.
The provided text does not include any information about:
- Acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication method, MRMC effectiveness study, standalone performance study, type of ground truth, or training set details for any study.
This document is a regulatory approval letter, not a study report. To obtain the information you're looking for, you would need access to the actual 510(k) submission documentation, which would include the performance data and potentially the study details that led to this approval.
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