The primary effectiveness endpoint is rate of subjects who have surgical success, with surgical success defined as the procedure not going into conversion. Conversion is defined as the switch from the robotic-assisted approach using the Hugo™ RAS system to laparoscopic, open surgery, or use of an alternative robotic-assisted system.

Enrolled subjects in whom the Hugo™ RAS procedure is begun, defined as the first skin incision. This is the full analysis set (FAS).

The primary safety endpoint is the overall rate of subjects with one or more procedure- and/or device-related surgical site events (SSEs), from the first incision through 30 days post-procedure. SSE is defined as the following complications:

• Surgical-site occurrence (SSO): Bleeding, Hemorrhage: Requiring transfusion; Bowel Injury; Bowel Obstruction; Cellulitis; Epigastric Vessel Injury; Symptomatic Hematoma: Requiring procedural intervention; Symptomatic Seroma: Requiring procedural intervention; Symptomatic Edema: Requiring procedural intervention
• Surgical-site infection (SSI): Infection occurring where the surgery took place, including superficial, deep, and organ space infections (standardized definition developed by the CDC)

30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit <23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).

Overall rate of subjects with one or more procedure- and/or device-related complications (Clavien-Dindo Grade I or higher), from the time of the first incision through 30 days post-procedure.

This is the same analysis population used for the Primary Safety Endpoint; however, two inguinal hernia subjects who were excluded from most 30-day endpoints for having no follow-up visits after the procedure had a non-major complication within 30-days, so were included in the denominator for this analysis.

Overall rate of subjects with one or more major procedure- and/or device-related complications (Clavien-Dindo Grade III or higher), from the time of the first incision through 30 days post-procedure.

30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit <23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).

Minutes from skin incision to skin closure.

Enrolled subjects in whom the Hugo™ RAS procedure is begun, defined as the first skin incision. This is the full analysis set (FAS).

Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia from the day after the index procedure to 30 days post-procedure.

30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit <23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).

Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia from the day after the index procedure to 30 days post-procedure.

30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit <23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).

Clinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator.

30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit <23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).

Clinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator. Suspected hernia recurrence(s) reported by a subject, but not confirmed by an investigator, will not be considered as a clinical hernia recurrence for this endpoint, but will be reported separately as a subject-reported recurrence.