Search Results

The HydroCision. Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

The HydroCision Debridement System uses a pressurized stream of sterile saline to lavage and clean wounds. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The svstem employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.

The provided document is a 510(k) summary for a modification to the HydroCision, Inc. Debridement System. It describes the device, its intended use, and a comparison to a legally marketed predicate device. However, it does not contain the detailed information requested regarding specific acceptance criteria, study results with numerical performance data, sample sizes for test and training sets, expert ground truth establishment, or multi-reader multi-case studies.

The document states: "Bench testing was conducted to determine device functionality and conformance to design input requirements." but does not provide any results or specific criteria.

Therefore,Based on the provided text, I cannot complete the request. The document is a 510(k) summary that states "Bench testing was conducted to determine device functionality and conformance to design input requirements" but does not provide any specific acceptance criteria, reported device performance data, study details (like sample sizes, ground truth, expert qualifications, or MRMC studies).

This document describes the device and its intended use but does not contain the performance study details required to answer your questions.

Ask a specific question about this device