Search Results

These instruments are intended for use by qualified surgeons during urologic laparoscopic procedures, including nephrectomy.

The KSEA SAWAHLE Electromechanical Morcellator is a motorized, reusable surgical device system, intended for use during urologic laparoscopic procedures, including nephrectomy. The UNIDRIVE II is its motor drive control unit.

I apologize, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request.

The document is an FDA 510(k) clearance letter for the KSEA SAWAHLE Electromechanical Morcellator. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. While it mentions the device's intended use and general description, it does not provide:

• Specific acceptance criteria: There is no table or detailed list of performance metrics that the device had to meet.
• Study details: Information regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details is entirely absent. The letter only states that the device is "substantially equivalent" based on similar features, design, and intended uses to predicate devices, and that minor differences in design and dimensions "raise no new issues of safety and effectiveness." This implies a comparison to existing devices rather than a detailed performance study with specific acceptance criteria as you've requested.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

Ask a specific question about this device