(90 days)
The CUSA Clarity Ultrasonic 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 main 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 CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provide ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:
Device: CUSA Clarity Ultrasonic Surgical Aspirator System
510(k) Number: K200774
This submission appears to be an update to an existing device (CUSA Clarity K182809), specifically an expansion of its neurosurgical indications for use, rather than a new device entirely. Therefore, the "acceptance criteria" and "study" described are primarily focused on supporting this updated indication for neurosurgery.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for this device, based on the provided text, is a substantial equivalence determination. This means the device is being compared to a predicate device (CUSA Clarity Ultrasonic Surgical Aspirator; K182809) rather than requiring specific performance targets independent of a predicate. The "acceptance criteria" revolve around demonstrating the new indications for use are safe and effective, and that the device's technological characteristics remain the same.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| New Neurosurgery Indications Safety and Effectiveness | The device can be safely and effectively used in neurosurgery, including removal of primary and secondary malignant and benign brain and spinal tumors (e.g., meningiomas and gliomas). The literature showed CUSA to be useful for the resection of tumors ranging from soft to firm consistencies, with benefits including enhanced tissue selectivity, preservation of healthy tissue, and more efficient debulking and resection. |
| Technological Equivalence to Predicate | The technological characteristics of the device are the same compared to the predicate device. |
| General Indications Equivalence to Predicate | No changes to the general Indications for Use compared to the predicate, confirming continued equivalence. |
2. Sample size used for the test set and the data provenance
- Test Set (Clinical Data): 72 peer-reviewed articles discussing neurosurgical cases.
- Number of Cases: Approximately 1,706 cases reported across these 72 articles.
- Data Provenance: Retrospective, derived from published peer-reviewed clinical literature. The country of origin is not specified but would be global as it's from peer-reviewed literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the traditional sense for this submission. The "ground truth" for this substantial equivalence determination is established by the existing body of peer-reviewed clinical literature. The "experts" are the authors and peer reviewers of the 72 articles themselves, who conducted the studies and produced the reported outcomes. Their qualifications would vary widely but generally include neurosurgeons, neurologists, and other medical professionals involved in the care and study of neurosurgical patients. The submission does not describe an independent panel of experts reviewing cases specifically for this 510(k) alongside the device.
4. Adjudication method for the test set
None in the context of an independent adjudication process for this 510(k) submission. The clinical data comes from already published and peer-reviewed articles, implying that any internal adjudication or consensus methods used by the authors of those individual studies would have occurred prior to publication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function or clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical tool, not a standalone diagnostic algorithm.
7. The type of ground truth used
The ground truth is established by clinical outcomes data reported in peer-reviewed medical literature. This includes observations on the safety and effectiveness of the CUSA device in various neurosurgical procedures, tumor debulking, tissue selectivity, and patient outcomes over approximately 40 years of use.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The clinical literature serves as the justification for the expanded indications.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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