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The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

The Senhance Surgical System is a console-based, multi-arm surgical system, which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows:

• . Cockpit - The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
• . Manipulator Arms - Independent mechanized support arms that interface with the endoscope and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
• Node A relay unit that connects the cockpit inputs to the manipulator arms in the system as configured, ● and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.

The provided text describes the TransEnterix Senhance Surgical System and its 510(k) submission (K180163) for expanding its indications for use to include inguinal hernia repair and cholecystectomy procedures. The document aims to demonstrate substantial equivalence to a predicate device (Senhance Surgical System, K171120) and reference devices (Intuitive Surgical da Vinci Xi Surgical System).

However, the provided document does not contain information about acceptance criteria in the form of a table or specific metrics for device performance (e.g., sensitivity, specificity, accuracy, or any quantifiable clinical endpoints with associated thresholds). Instead, it presents comparative clinical data from case series for the new indications against published literature data for predicate and reference devices, and standard laparoscopic techniques. The "acceptance criteria" appear to be implicit in the comparative study outcomes, where the Senhance System's performance is deemed "similar," "comparable," or "as safe and effective" as the comparators.

Therefore, I cannot generate a table of acceptance criteria and reported device performance as requested, because specific, quantitative acceptance criteria are not explicitly stated in the provided text for these procedures for the Senhance Surgical System.

I will, however, provide the available information regarding the studies and ground truth, addressing as many points of your request as possible based only on the provided text.

Here's a summary of the study information based on the provided text:

Study Information for TransEnterix Senhance Surgical System (K180163) - Expansion for Cholecystectomy and Inguinal Hernia Repair

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, specific quantitative acceptance criteria are not explicitly stated in the provided document. The document describes a comparative approach where the Senhance System's clinical outcomes are compared to published literature data from predicate/reference robotic systems and traditional laparoscopic techniques. The "acceptance" is implicitly based on achieving "comparable" or "similar" outcomes, indicating "as safe and effective."

Below are the outcomes reported for the Senhance System and comparators, which form the basis of the substantial equivalence claim.

2. Sample Sizes and Data Provenance:

• Cholecystectomy Test Set:

  • Senhance System: 40 patients (20 from Imperial College, 20 from Hamburg University). Data provenance: Retrospective chart reviews. Country of origin for the Senhance data is not explicitly stated beyond "Imperial College" and "Hamburg University," implying data from UK and Germany, respectively.
  • Reference da Vinci System: 1435 patients (data compiled from 19 papers from a PubMed literature search, years 2000-2018). Provenance: Literature.
  • Laparoscopic arm (Huang et al meta-analysis): 921 patients (summarized from 13 trials). Provenance: Literature (meta-analysis).

• Inguinal Hernia Repair Test Set:

  • Senhance System: 64 patients who underwent 76 transabdominal preperitoneal (TAPP) inguinal hernia repairs. Data provenance: Retrospective chart review. Country of origin not explicitly stated.
  • Reference da Vinci System: 652 patients (data from 510(k) summary K170713). Provenance: Literature (previous 510(k) submission).
  • Laparoscopic Cohort: 3457 patients (data from 11 publications referenced in Bittner, et al.). Provenance: Literature.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. The studies are clinical case series and comparisons to published literature, not evaluations of an AI's diagnostic performance based on expert-labeled ground truth annotations on medical images. The "ground truth" here is the actual clinical outcome of surgical procedures.

4. Adjudication Method for the Test Set:

• Not Applicable explicitly. As these are retrospective chart reviews and literature comparisons of surgical outcomes (not image interpretation or diagnostic tasks), an adjudication method in the context of expert consensus for ground truth establishment is not described or relevant. For intraoperative complications or conversions, these would have been recorded by the operating room staff and surgeons at the time of the procedure and subsequently extracted from patient charts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This was not an MRMC study comparing human readers with and without AI assistance. This was a study comparing the clinical outcomes of a robotic surgical system (Senhance) to other surgical methods (other robotic systems, traditional laparoscopy). The Senhance System is a surgical tool, not a diagnostic AI system assisting human readers.

6. Standalone (Algorithm Only) Performance:

• Not Applicable. The Senhance System is a surgical device operated by a human surgeon; it is not a standalone algorithm without human-in-the-loop performance. Its performance is human-in-the-loop.

7. Type of Ground Truth Used:

• Clinical Outcomes Data: The ground truth for this device's performance is derived from real-world clinical outcomes of surgical procedures (e.g., complications, operative time, length of stay, conversions, reoperation, readmission), as documented in patient charts and published literature.

8. Sample Size for the Training Set:

• Not Applicable / Not Explicitly Stated. The Senhance System is a mechanical and software-controlled surgical device, not a machine learning model that undergoes "training" in the conventional sense of machine learning algorithms for diagnostic tasks. The "training" of the device (i.e., its development and refinement) would involve engineering, bench testing, and pre-clinical studies, not a "training set" of patient data for learning algorithms. The software updates mentioned (Software Compatibility Check Feature, R&D Mode, Service function for Automated Instrument Calibration) were subject to software V&V testing, not machine learning training.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As per point 8, there isn't a "training set" with established ground truth in the context of machine learning model development. The safety and effectiveness of the device's design and software were established through traditional engineering and software verification and validation methods, and then confirmed clinically through the comparative case series.

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