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510(k) Data Aggregation
(324 days)
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
Puracol® Plus Ag MicroScaffold™ Wound Dressing is indicated for the management of:
- Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- First and second degree burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Trauma wounds healing by secondary intention
- Dehisced wounds
- Surgical wounds
- Dehisced surgical wounds
These dressings may be cut to size and may be layered for the management of deep wounds.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a wound dressing, which grants market approval by deeming the device substantially equivalent to a predicate device. It specifies indications for use, precautions, and contraindications.
However, it does not provide any details about:
- Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc.)
- Details of a study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Whether MRMC or standalone comparative effectiveness studies were performed, or any associated effect sizes.
- How ground truth was established for training or test sets.
Essentially, this document is a regulatory approval notice, not a detailed scientific study report on device performance.
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