(79 days)
The Transorbent and ThinSite Topical Border Wound Dressings are intended for use in the management of partial and full thickness wounds, Stage I -IV pressure ulcers, arterial and venous stasis leg ulcers, and to aid in the prevention of skin breakdown. They are also intended for use in post-surgical wounds, biopsy sites, minor abrasions and lacerations, suture sites, partial thickness and full thickness dermatological sites, laparoscopic incisional sites, and drainage tube sites.
The Transorbent and ThinSite Topical Border Wound Dressings are a multi-layered construction. The dressings utilize these various layers to optimize their functional abilities. The outer border film with adhesive bonds the dressing to the contact skin, and maintains the dressing in position until removed. Then there is an adhesive/fabric laminate that bonds the dressing to the wound site. The next layer is a hydrogel layer which absorbs and transfers exudate away from the wound, and captures it to facilitate the transfer of moisture vapor away from the wound. An integral adhesive bonds this portion of the dressing to an outer film (ThinSite) or film/foam (Transorbent) layer, which prevents excess loss of moisture at the wound site, while assisting in the transmission of moisture vapor from the dressing.
The provided text does not contain information on acceptance criteria for a medical device or a study proving that a device meets such criteria. The document is a 510(k) Summary for Transorbent and ThinSite Topical Border Wound Dressing, focusing on device description, predicate devices, and intended use for regulatory clearance. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about a multi-reader, multi-case (MRMC) comparative effectiveness study, or effect sizes of human readers with/without AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document mentions "biocompatibility testing" but provides no details about the acceptance criteria for this testing, the study design, or the results.
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