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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 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

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, benign laparoscopic-assisted surgical procedures. The system consists of two (2) Anovo Instrument ARMS, Anovo Surgeon Console, Anovo Robotic Control Unit (RCU), 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. The Anovo Surgical System Surgeon Console is located outside of the sterile zone.

The Anovo Surgical System is a modification of the Anovo Surgical System Model 6Ne ("Predicate Device" K242157), including software update and Surgeon Console hardware modifications to support the use of an Off-the-Shelf FDA-cleared Endoscope Arm, SOLOASSIST II by AKTORmed (K233312) as an optional accessory (without the SOLOASSIST II hand-held joystick and Voice Control features). The Endoscope Arm can be connected to the Surgeon Console and controlled by the Surgeon through the ARMS Controllers. The annotation feature was removed, and the annotation pedal was replaced with the Endoscope control pedal. There are no differences in the system RCU, Instruments, and accessories.

The provided FDA 510(k) clearance letter for the Anovo Surgical System (6Ne) describes various performance evaluations conducted. However, it does not provide specific acceptance criteria or quantitative performance metrics for the device itself or a study demonstrating these criteria were explicitly met in a table format as requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Anovo Surgical System Model 6Ne K242157) through various tests, primarily related to safety, functionality, and technological characteristics, rather than establishing new, specific quantitative performance criteria for the device's surgical capabilities.

Therefore, many sections of your request cannot be fully answered with the information provided in the given text.

Here's a breakdown of what can be extracted and what information is missing:

Acceptance Criteria and Reported Device Performance

The document states that "The Anovo Surgical System 6Ne met all the predefined specific requirements related to clinical compatibility, performance, and safety." However, it does not detail what these specific quantitative requirements or acceptance criteria were for the device beyond general statements of successful performance of surgical tasks.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Description: The letter refers to a "Pre-Clinical Cadaver Study" and a "Human Factors" study.
• Sample Size (Cadaver Study): "A female cadaver model was chosen for this study..." (implies n=1 cadaver model or a very small, unspecified number of cadavers).
• Sample Size (Human Factors): "Representative US Surgeons evaluated the Anovo Surgical System..." (number of surgeons/evaluation sessions not specified).
• Data Provenance:
  • Cadaver Study: The study used "female cadaver models." No country of origin is specified for the cadavers themselves, but the study was performed as part of a submission by an Israeli company (Momentis Surgical Ltd.).
  • Human Factors: "Representative US Surgeons" were used, implying the study was conducted with US clinicians.
• Study Type: Both studies mentioned appear to be prospective evaluations (i.e., new data generated for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Cadaver Study: The study "demonstrated that the System can successfully perform all surgical tasks". This implies an evaluation by the study team or expert oversight, but the number and qualifications of experts directly establishing "ground truth" (e.g., successful task completion, surgical outcomes on cadavers) are not specified.
• Human Factors Study: "Representative US Surgeons evaluated the Anovo Surgical System... by performing predefined critical tasks." These surgeons act as the evaluators, but their number and specific qualifications (beyond "US Surgeons") are not detailed. It's not clear if there was an independent "ground truth" established or if the surgeons' performance was the evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The document does not specify any formal adjudication method for either the cadaver study or the human factors study. It describes the conduct and outcomes but not the process of resolving potential disagreements or confirming "ground truth" if multiple evaluators were involved.

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 MRMC comparative effectiveness study was done as described in the context of human readers + AI vs. human readers alone. The device is a surgical system, not an AI-powered diagnostic tool. The document describes a "Human Factors" study where surgeons evaluated the system's interface, implying a usability and safety assessment, not a comparative effectiveness study involving AI assistance for interpretive tasks.

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

• Not applicable / No standalone algorithmic performance study was done. The Anovo Surgical System is an "endoscopic instrument control system" that assists human surgeons. It's not an AI algorithm performing diagnostic tasks independently. The software testing mentioned is for the control system's functionality and adherence to software development standards, not for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cadaver Study: "The results of the study demonstrated that the System can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures." This suggests "ground truth" was established by expert observation/evaluation of surgical task completion and clinical compatibility in a cadaver model environment. There is no mention of pathology or long-term outcomes data from cadavers.
• Human Factors Study: The "ground truth" here relates to the usability and safety of the system. This was established through observation and analysis of representative US Surgeons' performance of predefined critical tasks in a simulated OR environment, aiming to identify use-related risks.

8. The sample size for the training set

• Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a separate training set. The "Software Testing" referred to is for the device's control software, not a machine learning model.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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