(60 days)
The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.
The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas
Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery – including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
The device within the scope of this premarket notification is the CUSA® Clarity 23kHz Single-Sided Bone Tip Pack that is intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.
The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was added to the Integra Lifesciences Corporation family of tissue ablation products. All CUSA systems are surgical aspirators that use ultrasonics and cavitation with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures.
The CUSA Clarity 23kHz Single-Sided Bone Tip Pack has the same intended use and technological characteristics as the predicate CUSA Clarity system, including all predicate tip pack accessories. A bone tip is currently cleared with the predicate CUSA Clarity system (CUSA Clarity 23 kHz Bone Tip). The primary modification of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack when compared to the currently cleared CUSA Clarity bone tip is that the subject device has a limited abrasive fragmentation surface at the distal end of the tip when compared to the existing bone tip.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. It appears to be a 510(k) summary for a medical device (CUSA® Clarity Ultrasonic Surgical Aspirator System) focusing on establishing substantial equivalence to a predicate device.
The information provided describes:
- Device Name: CUSA® Clarity Ultrasonic Surgical Aspirator System
- Indication for Use: Surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue are desirable. This includes various surgical specialties like neurosurgery, gastrointestinal, urological, general, and laparoscopic surgery.
- Predicate Device: CUSA® Clarity Ultrasonic Surgical Aspirator System K200774
- Device Description: The subject device is a CUSA® Clarity 23kHz Single-Sided Bone Tip Pack. The primary modification compared to the predicate bone tip is a limited abrasive fragmentation surface at the distal end.
- Non-clinical testing performed: Sterilization, shipping, stability, biocompatibility, EMC, electrical safety, and bench testing to verify requirements like tissue fragmentation rate, tip life, torque functionality, and functionality within environmental variations.
- Conclusion: The non-clinical testing indicates substantial equivalence to the predicate device.
- Clinical Studies: No clinical studies were performed or required, as performance tests were deemed sufficient to support substantial equivalence.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study results, or type of ground truth, as these details are not present in the provided document.
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