(30 days)
The UltraCision 5mm Instruments are intended for the cutting and coagulation of soft tissues.
The UltraCision 5mm Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The UltraCision® 5mm Instruments as described in this special premarket notification are hand held instruments available in a 10cm, 14cm, and 32cm Curved Blade configuration and a 10cm and 14cm Sharp or Dissecting Hook Blade configuration. An optional blade grip is included in the 14cm configurations. When attached to the ultrasonic hand piece and generator, ultrasonic activation of the blade allows the instrument to cut and coagulate tissue.
The provided text does not contain specific acceptance criteria or a study that evaluates a device against such criteria in the manner requested. The document is a 510(k) Summary of Safety and Effectiveness for the UltraCision® 5mm Instruments, which describes the device, its intended use, and indicates that preclinical testing was performed to ensure the device performs as intended. However, it does not provide details about the specific acceptance criteria, performance metrics, study design, sample sizes, ground truth establishment, or expert involvement as outlined in the request.
Instead, the document primarily focuses on establishing substantial equivalence to previously marketed predicate devices.
Therefore, I cannot provide the requested information.
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