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The Anovo™ Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy.

The Anovo™ Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy.

The Anovo™ Instrument ARM Curved Scissors and the Anovo™ Instrument ARM Hook Electrode are intended for use with the Anovo™ Surgical System.

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 laparoscopic-assisted transvaginal benign 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™ Instrument ARM Curved Scissors and Anovo™ Instrument ARM Hook Electrode are optional instruments for the Anovo™ Surgical System Model 6N. The Anovo™ Surgical System Model 6N with Instrument ARM Grasper end-effector ("Predicate Device") was the subject of a De Novo request (DEN190022) for transvaginal access to gynecological procedures and was granted a marketing authorization in February 2021. Both the Anovo™ Instrument ARM Curved Scissors and Hook Electrode are intended to be used with the Anovo™ Surgical System. The Anovo™ Surgical System comprises the Anovo™ Surgeon Console operated by a nonsterile surgeon, two sterile instruments (Instrument ARMS) actuated by the non-sterile, Anovo™ Robotic Control Unit (RCU). The system allows the physician to operate the Instrument ARMS from the Anovo™ Surgeon Console by manipulating the ARMS Controllers under visual guidance. No changes were made to the Anovo™ Surgical System for the scope of this submission.

The provided text describes a 510(k) premarket notification for new surgical instruments (Anovo™ Instrument ARM Curved Scissors and Anovo™ Instrument ARM Hook Electrode) intended for use with an existing surgical system (Anovo™ Surgical System Model 6N). The submission aims to demonstrate substantial equivalence to a predicate device (Anovo™ Instrument ARM Grasper end-effector).

However, the document does not describe the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of an AI/ML medical device. Instead, it focuses on the substantial equivalence of surgical instruments to a predicate device through bench testing, pre-clinical animal studies, thermal damage testing, and biocompatibility testing.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI/ML device based on the provided text. The information requested (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance) is relevant to AI/ML device evaluations and is not present in this 510(k) summary for surgical instruments.

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