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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: Neurosurgery, Plastic and Reconstructive Surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
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 optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System. The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device added to the Integra Lifesciences Corporation family of tissue ablation products. There are three (3) systems currently marketed in the United States: CUSA® Clarity Ultrasonic Surgical Aspirator System, CUSA® Excel+ Ultrasonic Surgical Aspirator System and CUSA® NXT Ultrasonic Tissue Ablation System. Of these currently marketed products, a CEM accessory is offered with the CUSA® Excel+ Ultrasonic Surgical Aspirator System that allows for coagulation capabilities at the surgical site. The CEM accessory that is offered with the CUSA® Clarity is nearly identical to its predecessor, modified for use with the CUSA® Clarity system. The CEM accessory will allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue. The CEM accessory consists of a nosecone, cable and plug which are molded together and packaged as one unit.

The provided document is a 510(k) summary for the CUSA® Clarity Ultrasonic Surgical Aspirator System with the optional Electrosurgery Module (CEM) accessory. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Based on the document, here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of quantitative acceptance criteria directly tied to specific performance metrics for the CEM accessory. Instead, it describes categories of non-clinical tests conducted to ensure safety and efficacy, and states that these tests were "successful."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state sample sizes for individual tests. It broadly mentions "non-clinical testing" and refers to "all 13 protocols within the 4 testing categories." This indicates various tests were performed, likely on multiple units or components, but specific numbers are not provided. The data provenance is implied to be from Integra LifeSciences Corporation's internal testing labs, likely in the USA given the company address, but no specific country of origin is mentioned for the data. All testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The study conducted was non-clinical (bench, mechanical, electrical, etc.) and did not involve human experts establishing ground truth in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies, particularly when establishing ground truth from multiple human readers/experts. The testing described is non-clinical.

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

No MRMC comparative effectiveness study was done. The device is an ultrasonic surgical aspirator with an electrosurgery module, not an AI-based diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI algorithm, so the concept of standalone algorithm performance is not applicable. The device's performance was evaluated through non-clinical bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" would be defined by engineering specifications, recognized standards (e.g., for biocompatibility, EMC, electrical safety), and predefined functional requirements (e.g., handpiece life, functionality under environmental variations, thermal effects). These are objective, measurable criteria established through engineering principles and regulatory standards rather than subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set mentioned in the context of this device.

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