Search Results

The SURx Laparoscopic Probe (LP) Radio Frequency (RF) System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

The SURx LP System consists of two components: the SURx LP Generator and the SURx LP Applicator. The SURx LP Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx LP Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, which means that a return pad is not required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. The SURx LP Generator is a radiofrequency (RF) electronic instrument. Software is utilized in the operation of the SURx LP Generator.

The provided text describes the regulatory clearance of a medical device and mentions clinical evaluations but does not contain the detailed information required to fill out the table of acceptance criteria or the specifics of a study proving a device meets those criteria.

Specifically, the document states:

• "Results of clinical evaluations were used to demonstrate that the SURx LP System functioned as clinically intended."
• "Sufficient data have been gathered from clinical studies to determine that the SURx LP System performs as clinically intended and that no new issues of safety and effectiveness are introduced."

However, it does not provide:

• A specific table of acceptance criteria (e.g., minimum accuracy, sensitivity, specificity thresholds).
• The reported device performance metrics against such criteria.
• The sample size for the test set or its provenance.
• Details about ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
• Information on MRMC studies or standalone algorithm performance.
• Sample size for and ground truth establishment methods for a training set.

Therefore, based only on the provided text, I cannot complete the requested table or provide a detailed description of the study as requested. The document's purpose is to confirm regulatory clearance based on substantial equivalence, not to detail the full clinical study methodology and results.

Ask a specific question about this device