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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:

Plastic and Reconstructive surgery, Orthopedic Surgery and Thoracic Surgery and the following specific uses:

Neurosurgery - including removal of primary and secondary malignant 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

Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis

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. The CUSA Clarity may also be optionally used with the CUSA Electrosurgical Modules which provide optional electrosurgical capability.

The information provided describes a 510(k) premarket notification for the CUSA® Clarity Ultrasonic Surgical Aspirator System, primarily focusing on a modification to its Indications for Use to include more specific gynecological surgery indications. The submission claims substantial equivalence to a predicate device (K182809) and did not involve any design or technological changes to the device itself. Therefore, the "acceptance criteria" and "device performance" in the traditional sense of a new or modified device's functional characteristics are not directly presented as a series of quantitative benchmarks met by a specific study on the device's technical performance. Instead, the "acceptance criteria" here refer to demonstrating that the expanded indications for use for gynecological surgery are safe and effective, supported by existing literature and showing no new safety or effectiveness concerns compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The "test set" in this context refers to the body of clinical evidence reviewed to support the expanded indications.

• Sample Size: 1,465 patients. This total is comprised of:
  • 272 patients for dysplasia or condyloma.
  • 630 patients for debulking procedures (cancers).
  • 18 patients for endometriosis.
  • The remaining patients likely fall into categories not specifically broken down or represent overlaps in articles.
• Data Provenance: The data was derived from an "analysis of peer-reviewed articles." This indicates a retrospective review of published clinical literature. The country of origin of the data is not specified but would likely span various international institutions given the nature of peer-reviewed publications over an extended period.

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

Not applicable in the typical sense. This was a literature review, not a study where experts established ground truth for a novel dataset. The "ground truth" is implicitly established by the reported outcomes in the published clinical studies themselves, which are conducted by various medical professionals (surgeons, pathologists, etc.) in their respective fields. The submission does not specify an independent panel of experts reviewing the collected literature to establish a "ground truth" for the purpose of this 510(k).

4. Adjudication method for the test set

Not applicable. There was no explicit adjudication method for a test set as this was a review of existing peer-reviewed literature. The outcomes reported in the individual studies within the literature served as the evidence.

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. The device is an ultrasonic surgical aspirator system, not an AI or imaging diagnostic device that involves human "readers" interpreting output. This submission focuses on the safety and effectiveness of the existing device for expanded (gynecological) indications.

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

Not applicable. The CUSA Clarity is a surgical instrument used by a surgeon, not a standalone algorithm.

7. The type of ground truth used

The "ground truth"-like evidence used was outcomes data and reported effectiveness/safety from published clinical studies. This includes:

• Achievement of desired treatment outcomes (e.g., successful removal of tissue).
• Reported presence or absence of postoperative complications.
• Preservation of vessels and nerves.
• Comparison of procedure durations.

8. The sample size for the training set

Not applicable. This was a 510(k) submission for an existing device with expanded indications, not an AI/algorithm development where a training set would be used. The "evidence" supporting the expanded indications comes from published literature.

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

Not applicable. As above, there was no training set for an algorithm.

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