Search Results

The LapMan Laparoscope Manipulator System and Accessories is indicated for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. The LapMan is indicated for specific laparoscopic surgical procedures as defined in the Operations Manual and should not be used for any other surgical procedure or purpose.

LapMan is a robotic computer-driven system used by surgeon to hold and position a rigid laparoscope/endoscope. Surgeon orders are transmitted to the robotic system by a radiofrequency Hand Controlled device. It is indicated for use in General surgery (laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding), Gynaecology (laparoscopic adnexal surgery i.e. ovarian cystectomy, oophorectomy, salpingectomy, salpingoneostomy, tubal reanastomosis, laparoscopic management of ectopic pregnancy, laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension) and Urology (laparoscopic prostatectomy).

The provided text is a 510(k) summary for the LapMan Laparoscope Manipulator. It does not contain information about acceptance criteria for device performance related to a clinical study, nor does it describe a study proving the device meets specific performance criteria through clinical outcomes or comparative effectiveness.

Instead, the document focuses on:

• Predicate Device Comparison: Highlighting differences in communication systems (radiofrequency vs. voice/wired) and motion characteristics (lower magnitude/speed for LapMan) compared to the AESOP 3000 System.
• Compliance with Standards: Detailing extensive testing conducted by accredited laboratories (PHOENIX TEST-LAB GmbH, SNCH laboratory) to ensure compliance with a range of electrical, electromagnetic compatibility (EMC), and environmental standards (e.g., EN 60529, IEC 601, EN 300 220-3, EN 60601-1-2, EN 61000 series).
• Regulatory Clearance: The FDA's substantial equivalence determination based on these engineering and safety tests, allowing the device to be marketed.

Therefore, the specific information requested about acceptance criteria and a study proving device performance in a clinical context (e.g., accuracy, sensitivity, specificity, or human reader improvement) is not present in the provided 510(k) summary. The document describes engineering and safety tests against established standards, not a clinical performance study with human subjects or AI-assisted performance analysis.

Based on the provided text, I cannot complete the table or answer the subsequent questions as they relate to clinical performance criteria and studies that are not described in this regulatory submission.

The information provided only relates to technical and safety evaluations against international standards.

Ask a specific question about this device