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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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The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels.

The Prime™ Adaptive Ultrasonic Scalpel System has three major components: Generator (with footswitch), Transducer Handpiece and instruments (or blades). The Prime™ 6000 Generator provides input/output control and operation interface to automatically adapt the ultrasonic power output for the tissue load encountered.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for the Prime™ Adaptive Ultrasonic Scalpel System, focusing on its substantial equivalence to predicate devices and adherence to various performance and safety standards.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily details:

• Device Name: Prime™ Adaptive Ultrasonic Scalpel System
• Indications for Use: Cutting and coagulation in open, laparoscopic, and endoscopic surgery where control of hemostasis and thermal spread is desired. Used for dissection, sealing, transection, and vessel coagulation. Can be an adjunct or substitute for electrosurgery, lasers, or steel scalpels.
• Key Components: Generator (Prime™ 6000), Transducer Handpiece, and Instruments/Blades.
• Technological Characteristics: Automatically adapts ultrasonic power output to tissue load, consistent vibration, non-sterile reusable blades validated for cleaning/sterilization, and a cable disconnect feature at the transducer handpiece for convenience.
• Predicate Devices: Ultracision® Harmonic Scalpel® series from Ethicon Endo-Surgery, Inc.
• Reference Device: Sonopet® Surgical Aspirator for its blue anodized blade tip surface.
• Standards Met: A comprehensive list of IEC, ISO, AAMI, CAN/CSA, and EN standards related to electrical safety, electromagnetic compatibility, biocompatibility, risk management, and software life cycle processes. These are general safety and performance standards for medical devices, not specific clinical performance criteria or results.

The document asserts "no new questions of safety or effectiveness" and concludes substantial equivalence, which is the basis for 510(k) clearance, rather than presenting a detailed clinical study demonstrating meeting specific performance criteria.

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