Search Results

The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMI), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff.

The KSEA Slotted Whisker Arthroscopic Blade is sold as a sterile, single use device. The blade is long enough to gain access to the surgical area and is designed to be used as an accessory to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.

This document is a 510(k) summary for a medical device (K963029, Karl Storz Slotted Whisker Arthroscopic Blade). It is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical study with performance metrics against pre-defined acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided text.

The document states: "The KSEA Slotted Whisker Arthroscopic Blade is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA Slotted Whisker Arthroscopic Blade and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices."

This indicates that the "study" proving the device meets criteria is primarily a comparison against existing legally marketed predicate devices to show that it is equally safe and effective, rather than a new performance study with quantitative acceptance metrics.

Since the provided text does not contain the information needed to fill out the table or answer the specific questions, I cannot generate the requested output.

Ask a specific question about this device