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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, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures, laparoscopic gynecological surgery, and laparoscopic urological surgery. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.

The Senhance Surgical System is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit.

More specifically, the Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.

In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.

Here's a breakdown of the acceptance criteria and study details based on the provided text for the Senhance Surgical System:

Acceptance Criteria and Device Performance

The provided document does not explicitly state numerical acceptance criteria for the expanded indication. Instead, it demonstrates that the Senhance Surgical System's performance for urological procedures is comparable or superior to existing alternative surgical techniques (robotic, laparoscopic, and open surgery) based on several clinical outcome metrics derived from a Systematic Literature Review (SLR) and real-world evidence from the TRUST registry.

The core acceptance is that the device, with its expanded indications for use, "does not raise different questions of safety or effectiveness or alter the fundamental therapeutic use of the system" compared to the predicate devices. The performance data presented in Table 18 supports this claim by showing favorable or similar outcomes.

Table 1: Acceptance Criteria (Implied Comparability) and Reported Device Performance

Note on Acceptance Criteria: The document focuses on demonstrating substantial equivalence by showing that the Senhance System's performance for urological procedures is safe and effective and comparable to established methods, rather than setting specific numerical thresholds as "acceptance criteria." The favorable comparison against SLR data serves as the "proof" of meeting this implied standard.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 416 urology cases performed using the Senhance system.
   • Data Provenance: Retrospective clinical data review from the TRUST registry. "TRUST" is a prospective, multi-center patient registry primarily for European clinical centers. For this study, sites additionally retrospectively enrolled previously treated patients (after obtaining informed consent) and entered retrospective data. The data collection for the TRUST registry is stated to be still ongoing. The study collected data from December 2017 to August 2023.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • The document does not explicitly state the number of experts or their qualifications for establishing the ground truth of the TRUST registry data. The data originates from clinical centers participating in the TRUST registry, implying that surgical outcomes and patient data were recorded by the healthcare professionals (surgeons, nurses, etc.) at those centers as part of their routine clinical practice and study participation.

3. Adjudication Method for the Test Set:

   • The document does not specify an adjudication method (e.g., 2+1, 3+1) for the clinical data collected in the TRUST registry. The data appears to be collected directly from clinical records and reported outcomes within the registry structure.

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

   • No, an MRMC comparative effectiveness study was not performed as described. The study compared the device's performance (Senhance System) to the performance of other surgical techniques (Robotic, Laparoscopy, Open) based on aggregated data from a registry and a systematic literature review. It did not involve multiple human readers assessing cases with and without AI assistance to measure reader improvement.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, in essence. The entire evaluation focuses on the performance of the "Senhance Surgical System" itself, which is a robotic-assisted surgical system. While a human surgeon is "in the loop" operating the system, the performance metrics (e.g., surgical complications, blood loss, operative time) are attributed to the system's use rather than analyzing the human-machine interaction for "improvement." The clinical data demonstrates the system's performance in isolation from a specific human reader improvement claim. The device is assisting the surgeon, so the performance reported is inherently "with assistance," but there isn't a comparison of human performance without the Senhance system to human performance with the Senhance system in a controlled observation experiment of the surgeon's performance. Instead, it compares the overall patient outcomes when using the system versus other surgical approaches.

6. Type of Ground Truth Used:

   • Clinical Outcomes Data: The ground truth for the test set (TRUST registry) is based on real-world clinical outcomes data and patient records from surgical procedures. This includes metrics like Length of Stay, Surgical Complications, Estimated Blood Loss, Readmission Rates, Reoperation Rates, Mortality, and Postoperative Complications.
   • Expert Consensus (Implicit in SLR): For the comparative data from the Systematic Literature Review, the "ground truth" for the aggregated averages comes from peer-reviewed research publications, where clinical outcomes are established and reported by the medical community.

7. Sample Size for the Training Set:

   • The document does not describe a "training set" in the context of an AI-driven imaging or diagnostic algorithm. The Senhance Surgical System is a robotic-assisted surgical system, and its development and validation would involve engineering verification and validation, bench testing, and clinical studies rather than an AI training/test split of data in the typical sense. The "Performance Data" section mentions "Extensive bench testing was conducted on the previously cleared Senhance system," but does not specify a separate training set.

8. How the Ground Truth for the Training Set Was Established:

   • As there is no "training set" described in the context of AI specific to this submission, this question is not directly applicable. The underlying engineering, functional, and safety validations for the robotic surgical system would have established its operational capabilities and safety through various testing methodologies, often guided by industry standards and expert engineering principles.

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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, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. 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 multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit. The purpose of this submission is to seek clearance for modifications to the indications for use to expand the types of surgical procedures for which the Senhance Surgical System may be used.

In this submission, the indications for use have been expanded to cover laparoscopic general surgical procedures. The new indications for use statement does not create a new intended use for the system.

The Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.

In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.

The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

The FDA clearance is for expanding the indications for use of the Senhance Surgical System. The acceptance criteria, while not explicitly stated as numerical targets in a formal table, are implicitly demonstrated by showing the device performs comparably to established alternative surgical techniques for the expanded indications. The study aims to show that the Senhance Surgical System is as safe and effective as traditional laparoscopic and robotically-assisted surgery for Nissen fundoplication, a representative general surgical procedure.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 34 patients.
  • Cohort 1: 18 patients
  • Cohort 2: 16 patients
• Data Provenance: Retrospective chart review.
  • Cohort 1: Germany
  • Cohort 2: Netherlands

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts, nor their qualifications, used to establish the ground truth for the retrospective chart review data. The chart review itself implies that the data recorded by the medical professionals involved in those cases formed the "ground truth."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the retrospective chart review data. The data appears to have been extracted directly from patient charts.

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

No, an MRMC comparative effectiveness study was not done. The study compares the device's performance based on real-world evidence (retrospective chart review) to published clinical literature on alternative surgical techniques (traditional laparoscopic and robotically-assisted surgery). It does not involve human readers evaluating cases with and without AI assistance for an effect size.

6. Standalone Performance Study

Yes, in a way, a standalone performance was done for the device in the context of real-world use. The retrospective chart review of Nissen fundoplication procedures using the Senhance system provides data on the device's performance without comparison to concurrent human performance. The comparison is made against historical data from other techniques.

7. Type of Ground Truth Used

The ground truth for the Senhance System's performance in the test set (the 34 Nissen fundoplication cases) is derived from clinical outcomes data from patient charts. This includes recorded metrics like hospital stay, complications, blood loss, conversion rates, etc.

8. Sample Size for the Training Set

The document does not provide information about a training set. The Senhance Surgical System is a robotic surgical system, not an AI or imaging device that typically requires a large training dataset for a model. The clinical data presented is for proving the safety and effectiveness of the device for expanded indications, not for training a specific algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a training set for an AI/algorithm is not described in this document. The device itself is a surgical system whose performance is being evaluated based on clinical outcomes.

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