(295 days)
The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: Venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
Acutek Hydrocolloid Wound Dressing, TIB 197013
This document is a 510(k) clearance letter for the Acutek Hydrocolloid Wound Dressing, TIB 197013. It determines that the device is substantially equivalent to devices marketed prior to May 28, 1976. This type of document, particularly one from 1998, focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/software medical device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device performance study is not applicable to this document.
The document states the "Indications For Use" (which can be considered the intended use and scope), and these are:
Indications For Use:
The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: Venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
Limitations (equivalent to acceptance criteria exclusions from labeling):
- This device may not be labeled for use on third-degree burns.
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound.
The "study that proves the device meets the acceptance criteria" in the context of a 510(k) for a traditional medical device prior to the widespread use of sophisticated AI would have involved demonstrating equivalence to a predicate device, often through bench testing, materials testing, and sometimes limited clinical data, but not typically in the format of an AI performance study as outlined in the request. The letter confirms that based on the submission, the device is substantially equivalent, allowing it to proceed to market under general controls.
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