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The device is intended for use in general surgery. The device is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The irrigation unit; forceps and single-use extension cable are accessories to the EMF PAL If designed to be used in soft tissue surgical procedures. Refer to the instructions for Use Manuals for further information on intended surgical applications and precautions and warnings for use of the device.

EMF PAL II - Main Generator Unit, Irrigation Unit, and Accessories

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "EMF PAL II - Main Generator Unit, Irrigation Unit, and Accessories," indicating that the device has been found substantially equivalent to legally marketed predicate devices.

The text specifies the device name, regulatory classification, product code, and indications for use, but it does not detail any performance metrics, studies, or criteria for acceptance that would allow me to populate the requested table or answer the specific questions about sample sizes, ground truth, or expert involvement.

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