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The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice transvaginal and transabdominal benign laparoscopic-assisted surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment.

The representative uses of the Anovo Surgical System are indicated for the following benign procedures:

• Total benign hysterectomy with salpingo-oophorectomy
• Total benign hysterectomy with salpingectomy
• Total benign hysterectomy
• Salpingectomy
• Oophorectomy
• Adnexectomy
• Ovarian cyst removal
• Ventral hernia

The Anovo™ Surgical System is a mountable electromechanical surgical system used in single-site surgical procedures through a transvaginal or transabdominal access point. The system consists of two (2) Anovo™ Instrument ARMS, Anovo™ Surgeon Console, Anovo™ Robotic Control Unit, and accessories (Anovo™ Pedestal, Anovo™ Access Kit and Anovo™ Sterile Drape for Robotic Control Unit).

The Instrument ARMS are connected to the RCU, which is attached to the Pedestal. The physician sits at the Anovo™ Surgeon Console and controls the Instrument ARMS by manipulating the ARMS Controllers. While manipulating the Instrument ARMS, the physician views the surgical site through a standard OR visualization system using a laparoscopic camera inserted through an abdominal port and views the main user interface at the Anovo™ Surgical System Surgeon Console. The Anovo™ Surgical System Surgeon Console is located outside of the sterile zone.

The system is designed to be used with an Electrosurgical Generator. The Anovo™ Surgical System is operated in conjunction with standard commercially available laparoscopic surgery visualization systems.

The provided text describes the Anovo Surgical System and includes information about its performance evaluation, but it does not explicitly list pre-defined acceptance criteria in a table format with corresponding device performance values for each criterion. Instead, it presents the results of various studies that collectively aim to demonstrate the device's safety and effectiveness for its expanded indications, particularly for ventral hernia repair.

However, based on the information provided, we can infer some criteria and reported performance:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not tabulated in the document, I will infer them from the reported study objectives and outcomes.

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

• Clinical Study (Test Set):

  • Sample Size: 30 subjects (N=30).
  • Data Provenance: Multi-center, single-arm, prospective study. Conducted in two sites outside the United States (Belgium and Israel).

• Cadaver Study (Test Set):

  • The document does not specify the sample size (number of cadavers) used for this study.
  • Data Provenance: Not specified, but generally cadaver studies are retrospective use of donated human remains.

• Human Factors Study (Test Set):

  • The document mentions "Representative users" but does not specify the number of users in the sample size.
  • Data Provenance: Conducted in a "simulated OR environment."

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

• The document does not explicitly state the number of experts used to establish a "ground truth" in the traditional sense (e.g., for diagnostic accuracy).
• For the Clinical Study: The "ground truth" is derived from the actual surgical outcomes, complications, operative times, etc., observed by the surgical teams and follow-up clinicians at the study sites. These would be trained physicians in an operating room environment, as the device is intended for use by "trained physicians."
• For the Cadaver Study: The "ground truth" of successful access, reach, and task completion would have been assessed by experienced surgeons or surgical residents performing the procedures on the cadavers.
• For Human Factors: The "ground truth" for usability and safety was established by "representative users" (presumably surgeons or surgical staff) performing predefined critical tasks and experts evaluating use-related risks.

4. Adjudication Method for the Test Set

• The document does not specify an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as would be common for diagnostic imaging studies where agreement on subtle findings might be required.
• For the Clinical Study, outcomes like conversion rates, adverse events, and procedure completion are generally objective metrics observed and recorded by the treating physicians and study coordinators/monitors, rather than requiring an explicit adjudication process for interpreting findings.
• The complications and adverse events were categorized as "not device related," implying a clinical judgment was made (presumably by the investigators/clinicians at the sites or a clinical events committee), but no formal adjudication committee or process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an electromechanical surgical system (robotics system), not an AI-based diagnostic imaging tool that would involve "human readers" interpreting images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context. The study focused on the performance of the surgical system itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

• This question is not applicable to the Anovo Surgical System. As a surgical robot, it inherently requires a "human-in-the-loop" (the surgeon operating the console). There is no "algorithm-only" performance for such a device; its function is always to assist the surgeon. The "standalone" performance if considered would be the system's mechanical and software reliability in performing the surgeon's commands, which is assessed through bench testing and software validation.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for the clinical study was based on clinical outcomes and observations during and after surgery, including:

  • Procedure completion (objective observation).
  • Conversion rates (objective observation).
  • Occurrence and type of adverse events, adverse device events, and serious adverse events (clinical diagnosis/observation).
  • Operative time (objective measurement).
  • Blood loss (objective measurement/estimation).
  • Hospital stay duration (objective record).
  • Mortality (objective record).
  • These are forms of outcomes data and expert clinical observation/diagnosis.

• Cadaver Study: The ground truth was based on direct observation and assessment by surgeons of the device's ability to access, reach, and perform tasks on anatomical structures within the cadaveric model. This is a form of expert observation/assessment in a simulated setting.

• Human Factors Study: The ground truth for usability and safety was established by observing "representative users" interacting with the system and experts identifying and assessing use-related risks. This is based on expert observation and assessment of user performance and risk analysis.

8. The Sample Size for the Training Set

• The document does not mention a "training set" in the context of device performance validation testing for the Anovo Surgical System for its expanded indications.
• For electro-mechanical systems, the "training" typically refers to the engineering design, simulation, and bench testing phases where parameters are refined and models are iterated, but not in the same sense as an AI model's training data.
• The "training" of the physicians using the system in the human factors study is mentioned, but this is user training, not data training for an algorithm.

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

• As a "training set" for an algorithm or data-driven model is not mentioned in this submission, this question is not applicable. The validation studies (clinical, cadaver, human factors, bench, software, etc.) are evaluating the final device's performance against its design requirements and safety/effectiveness goals, not training an underlying model.

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