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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 CUSA® Clarity Ultrasonic Surgical Aspirator System was originally cleared October 14, 2016 (K161882). The purpose of this submission is to obtain FDA clearance for expanding the current CUSA Clarity indication for use statement to add a hard tissue indication (bone) and to add a 23 kHz handpiece and related accessories for use with the previously cleared CUSA Clarity system. The submission includes a bone tip that facilitates the removal of hard tissue, and additional tips intended for the removal of soft tissue.

The CUSA Clarity system shares the same intended use and principle of operation as previous CUSA systems. All CUSA systems are surgical aspirators that use ultrasonics and cavitation, in combination 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 consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provides 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. The CUSA Clarity system, including the 23 kHz components that are the subject of this submission, will be labelled MR Unsafe.

The provided text is a 510(k) summary for the CUSA Clarity Ultrasonic Surgical Aspirator System. It details an FDA clearance for expanding the device's indications to include hard tissue (bone) and adding a 23 kHz handpiece and related accessories.

Based on the information provided, here's a description of the acceptance criteria and study that proves the device meets them:

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

The document summarizes performance testing but does not explicitly present acceptance criteria in a formal table with pass/fail results. Instead, it lists categories of testing and a general statement of success.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for any of the performance tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as the studies were non-clinical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the studies were non-clinical performance (bench) tests, not human-in-the-loop studies requiring expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable as the studies were non-clinical performance (bench) tests, not human-in-the-loop studies.

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 submission explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate devices." This device is a surgical aspirator, not an AI-assisted diagnostic tool for human readers.

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

The device itself is a surgical tool, not an algorithm. The performance tests ("standalone" in the sense of device-only operation) were bench tests to verify system requirements, such as tissue fragmentation rate, handpiece life, and electrical safety.

7. The type of ground truth used:

For the non-clinical performance tests, the "ground truth" would be defined by the predefined technical specifications and standards (e.g., acceptable fragmentation rates, lifespan expectations, safety limits). The document does not explicitly state the specific ground truth metrics but implies they were based on established engineering and regulatory standards for medical device performance.

8. The sample size for the training set:

This information is not applicable. The CUSA Clarity Ultrasonic Surgical Aspirator System is a physical medical device, not a machine learning model that requires training data.

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

This information is not applicable as the device is not a machine learning model.

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