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The Ultrasonic Scalpel System is intended to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 5 mm in diameter while using the power level 1. Device have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

The Ultrasonic Scalpel System is an ultrasonic dissection and coagulation system composed of four components: the single use Ultrasonic Scalpel including four shaft lengths; a multiple use transducer; a generator and a foot switch. The single-use Ultrasonic Scalpel with EO sterilization contains the waveguide, shaft, jaws, trigger and activation button. Trigger activation opens and closes the jaws against the distal tip of the waveguide where the tissue is clamped. The Ultrasonic Generator provides AC electrical energy to drive the Ultrasonic Transducer. The Ultrasonic Transducer converts the electrical energy into mechanical vibrations, making the Ultrasonic Scalpel waveguide tip keep vibrating with amplitude between 50μm-100μm at frequency about 55.5kHz. When the vibrating Ultrasonic Scalpel waveguide tip contacts with soft tissues, the hydrogen bond in proteins of the soft tissues is broken apart. The proteins become viscous and coagulate so as to stop bleeding and reduce damage to soft tissues in cutting. The single-use Ultrasonic Scalpel with EO sterilization, the Ultrasonic Generator and Ultrasonic Transducer are of non-sterile package, the transducer has to be sterilized by users before being used in surgery. This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

The provided document is a 510(k) Premarket Notification for a medical device, the "Ultrasonic Scalpel System," and as such, it does not describe an AI/ML-driven device. Therefore, the questions related to AI acceptance criteria, training/test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document.

The document discusses the regulatory review of a physical medical device (ultrasonic scalpel system) and its substantial equivalence to predicate devices, focusing on:

• Device Description: Components (generator, transducer, scalpel, foot switch), working principle.
• Indications for Use: Transect, dissect, coagulate tissue in open and endoscopic general surgical procedures, particularly for vessels up to 5mm.
• Performance Data: Bench testing, animal studies (acute and chronic), sterilization validation, biocompatibility, electrical safety/EMC, packaging, and shelf-life.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" and many of the sub-questions are tailored to AI/ML devices, I will interpret "device" as the Ultrasonic Scalpel System described in the document and apply the relevant information provided.

Acceptance Criteria and Study for the Ultrasonic Scalpel System (Non-AI Device)

The document does not explicitly present a table of "acceptance criteria" in the format typically used for AI/ML performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are implicitly derived from various performance tests conducted to demonstrate safety and effectiveness and substantial equivalence to predicate devices. The "reported device performance" is the successful outcome of these tests, satisfying the underlying safety and performance standards.

Here's an interpretation of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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