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The CUSA® Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft 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 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 is the newest device to be added to the Integra Lifesciences Corporation family of tissue ablation products. There are two (2) systems currently marketed in the United States: CUSA® Excel+ Ultrasonic Surgical Aspirator System and CUSA® NXT Ultrasonic Tissue Ablation System These two systems as well as all predecessor devices share(d) the same principle of operation. All CUSA systems are surgical aspirators which use ultrasonics and cavitation to fragment and emulsify tissue, and aspiration at the end of the surgical tip to remove unwanted tissue. Each model has unique features and attributes that may not be found in the others. Like the predicate devices. CUSA Clarity is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies, and removes unwanted tissue. It allows for the selective 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, a surgical handpiece that provides ultrasonic mechanical energy, a footswitch to allow user control over the ultrasonics, a titanium surgical tip, irrigation flue, and a suction/irrigation system (manifold tubing and vacuum canister). The CUSA Clarity system, including all accessories and components, will be labeled MR Unsafe.

This document refers to the CUSA Clarity Ultrasonic Surgical Aspirator System, which is an ultrasonic surgical aspirator. This type of device fragments, emulsifies, and aspirates soft tissue during surgical procedures. The document does not describe the specific acceptance criteria or a detailed study proving the device meets those criteria in the way one would expect for an AI/ML powered device, image analysis software, or a diagnostic tool.

Instead, the provided text outlines the regulatory submission for a traditional medical device (an ultrasonic surgical aspirator). The focus is on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against specific clinical efficacy metrics for a new diagnostic or predictive algorithm.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not explicitly detailed in this type of submission for a physical surgical device.

Based on the provided text, here's what can be extracted and inferred:

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

The document states: "A suite of performance tests was executed to show substantial equivalence with the predicate devices." It then lists categories of testing. However, it does not provide a table with specific quantitative acceptance criteria (e.g., in terms of fragmentation rate, aspiration efficiency, or tissue selectivity) and corresponding performance metrics for the CUSA Clarity. Instead, the general "acceptance criterion" is successful completion of tests demonstrating substantial equivalence.

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

• Sample size used for the test set: Not explicitly stated. The document refers to "a suite of performance tests" and "50 protocols" completed successfully. These protocols would involve testing samples of the device and its components, but the specific number of units or test runs for each protocol is not provided.
• Data provenance: Not explicitly stated. The testing appears to be internal to the manufacturer (Integra LifeSciences Corporation) and conducted in a lab/bench setting to verify engineering performance and compliance with standards, rather than clinical data from patients.

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 concept is not applicable in the context of this device submission. Ground truth, in the AI/ML sense, is usually associated with labeling or interpreting medical images or data. For a surgical aspirator, "ground truth" would relate to the physical performance characteristics of the device (e.g., its power output, aspiration flow, material compatibility), which are measured by instruments and verified against engineering specifications and standards, not by human experts interpreting clinical data for diagnostic accuracy.

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

Not applicable. Adjudication methods are typically used for establishing consensus on "ground truth" labels in clinical data for AI/ML models. For a physical device's performance testing, results are typically determined by measurement instruments and engineering analysis against predefined specifications.

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. MRMC studies are specific to evaluating the clinical performance of diagnostic or prognostic tools, often involving human readers (e.g., radiologists) and sometimes comparing their performance with and without AI assistance. The CUSA Clarity is a surgical instrument, not a diagnostic imaging or AI-powered interpretation tool. No such study is mentioned or relevant here.

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

Not applicable. The CUSA Clarity is a human-operated surgical instrument. There is no "algorithm only" performance to evaluate in this context.

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

As discussed, the concept of "ground truth" in the AI/ML sense is not directly applicable. The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., for sterilization, biocompatibility, electrical safety, EMC), and internal protocols that define acceptable performance ranges for physical characteristics. Compliance with these specifications and standards constitutes meeting the "ground truth" for a physical device.

8. The sample size for the training set

Not applicable. The CUSA Clarity is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this device.

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