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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

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Animal Testing: The document states "animal study was conducted on porcine model." It mentions "all animals" and "each animal" for observations but does not specify the exact number of pigs used for the acute and 21-day chronic animal studies.
  • Other tests (Sterilization, Biocompatibility, Electrical Safety, Performance, Packaging): Standard validation numbers for these tests are not explicitly stated (e.g., number of units tested for electrical safety or sterility assurance level).
• Data Provenance: The document implies that the studies were conducted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. in China.
  • Retrospective/Prospective: All described studies (in vitro, animal studies, bench testing) are inherently prospective studies designed specifically to test the performance and safety of the proposed device.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is a non-AI/ML medical device. Ground truth, in the context of device performance, is established through direct measurements, observations, and histological analyses in controlled laboratory and animal settings, not through expert consensus on diagnostic images.
• The "experts" involved would be qualified laboratory technicians, veterinarians, pathologists, and engineers conducting the tests, but their role is not "establishing ground truth for a test set" in the sense of image interpretation for AI.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a physical device and not an AI/ML system requiring human interpretation for "ground truth," adjudication methods like 2+1 or 3+1 are not relevant. Test results are based on objective measurements and established protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This type of study is specific to diagnostic imaging AI, evaluating how human reader performance changes with AI assistance. The Ultrasonic Scalpel System is a surgical instrument, not an imaging AI; thus, an MRMC study was not performed.

6. Standalone (Algorithm Only) Performance

• Not Applicable. There is no standalone algorithm for this physical ultrasonic scalpel system. The device functions physically as an instrument.

7. Type of Ground Truth Used

• For this device, "ground truth" refers to direct, objective measurements and observations of the device's physical and biological effects:
  • Sterility: Absence of viable microorganisms, EO residuals within limits.
  • Biocompatibility: Absence of toxic, irritating, or sensitizing reactions in biological assays.
  • Electrical Safety/EMC: Compliance with international safety standards (e.g., leakage current, electromagnetic interference).
  • Performance/Functional Tests: Meeting pre-defined engineering specifications for frequency, amplitude, power output, etc.
  • Burst Pressure: Measured pressure required to burst a sealed vessel.
  • Acute Animal Study: Direct observation of thermal damage and visual confirmation of sealing integrity.
  • Chronic Animal Study: Gross pathological examination of sealed sites, histological analysis of tissue for inflammatory cells, fibrosis, etc. (performed by pathologists).

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML system that undergoes a "training phase" on a dataset. The development of the device would involve engineering design, prototyping, and iterative testing, not "training" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no "training set" for an AI algorithm in this context, the concept of establishing ground truth for it does not apply.

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