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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 Model 6Ne is an electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Instrument ARMS, a Surgeon Console, a Robotic Control Unit Assembly, and System Accessories (Sterile Drape, Vaginal Access Kit, Cables, and Pedestal). During clinical use, surgeons operate the Instrument ARMS from the Surgeon Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.

Anovo™ Surgical System 6Ne, including Anovo™ Surgeon Console 6Ne and Anovo™ Robotic Control Unit 6Ne, is an additional enhanced configuration of the Anovo™ 6N, with Anovo™ Surgeon Console 6N and Anovo™ Robotic Control Unit 6N ("Predicate Device") that was the subject of a De Novo request (DEN190022). There are no differences in the system instruments and accessories compared to the Anovo™ 6N, and the Surgeon Console and Robotic Control Unit Model 6Ne will be offered with the same Instrument and accessories.

This document (K242157) is a 510(k) Premarket Notification from the FDA for the Momentis Surgical Ltd. Anovo Surgical System (Model 6Ne). It outlines the device, its intended use, a comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

However, the provided text does not include specific quantitative acceptance criteria or reported device performance metrics in the format of "A table of acceptance criteria and the reported device performance." It mentions various types of testing conducted but doesn't provide the numerical results against predefined thresholds for any specific performance aspect.

Furthermore, it does not describe a study involving an AI/algorithm that requires detailed information about:

• Sample size for test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
• Stand-alone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses tests for a surgical system (a robotic device), not an AI algorithm for diagnostic or prognostic purposes. The performance evaluation section details:

• Bench Testing: Demonstrates design output meets design input requirements (dimensional measurements, mechanical, functional verification).
• Software Testing: Covered by IEC 62304 and FDA guidance for device software functions.
• Cybersecurity: Compliance with FD&C Act and FDA guidance.
• Electrical Safety and Electromagnetic Compatibility (EMC): In accordance with various IEC standards (IEC 60601-1, IEC 60601-1-6, IEC 80601-2-77, etc.).
• Human Factors: Performed according to ISO/IEC 62366-1:2015 and FDA guidance. Representative US Surgeons evaluated the system in a simulated OR environment. The study "demonstrated that the Anovo™ Surgical System 6Ne supports safe and effective use by representative users" and that "all relevant use-related risks were found to be acceptable."
• Pre-Clinical Cadaver Study: Performed on five (5) female cadavers by two (2) trained Surgeons to evaluate the system's ability to access and reach anatomical regions and structures during surgical procedures. The conclusion was that the system "can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures" and "met all the predefined specific requirements related to clinical compatibility, performance, and safety."

In summary, the provided document describes the regulatory approval of a physical robotic surgical system and its associated software/controls, not an AI algorithm intended for diagnostic image analysis or similar tasks that would require the specific details requested in your prompt regarding AI model performance, ground truth establishment, expert reading, and MRMC studies.

Therefore, I cannot extract the information requested about AI performance, training sets, ground truth methodology, or MRMC studies because it is not present in this document, which pertains to a different type of medical device (a surgical robot).

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