(21 days)
The VersaJet™ Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.
The VersaJet Hydrosurgery System uses pressurized streams of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. The device provides cutting, irrigation and evacuation in the same tool. The stream of fluid simultaneously washes the tissue surface and removes foreign material from the wound or surgical site. 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 fluid acts to ablate the surface of the tissue and propel excised tissue and debris out of the surgical site. The debris and fluid are directed immediately within the instrument into a flexible tube, which carries the effluent to the drain or a collection canister. The system employs two basic system components: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text.
The text describes a 510(k) Summary for the VersaJet™ Hydrosurgery System. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not necessarily for proving the device meets specific acceptance criteria through a dedicated study with pre-defined performance metrics.
Here's why the requested information isn't directly available in the provided text:
- Acceptance Criteria/Performance Metrics: The document does not define specific quantitative or qualitative acceptance criteria (e.g., a certain percentage reduction in bacterial load, a specific time to debridement, or a defined tissue sparing percentage) for the device's performance. It describes the device's function and intended use.
- Study Design for Performance Proof: The document focuses primarily on comparing the subject device to a predicate device (K011612) and expanding its indications for use to include burn wounds. The "Clinical Literature Review" section refers to two existing external clinical studies/descriptions from Rennekampff et al. and Klein et al. These are cited to support the expanded indication for burn wounds, but they are not presented as a pre-planned, dedicated study designed by Smith & Nephew to prove the device meets specific, pre-defined acceptance criteria for its overall performance.
- Missing Details for Study Analysis: Consequently, details like sample size for test sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used for performance assessment, or training set specifics are not addressed because the review section is a summary of external literature, not a report of an internal validation study against a pre-defined performance threshold.
In summary, the provided document is a regulatory submission for substantial equivalence and an expanded indication, which often relies on a comparison to a predicate device and existing literature, rather than a detailed report of a new study designed to meet specific, pre-defined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study design based on the information given.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.