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 beingn 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 lapatic resection, lobectomy or trisegmentectony, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
The devices within the scope of this premarket notification are the CUSA® Clarity 23kHz Laparoscopic Tip Packs that are intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.
The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was 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 Clarity), CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA Excel+) and CUSA® NXT Ultrasonic Tissue Ablation System (CUSA NXT). 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 23kHz Laparoscopic Tip Packs have the same intended use and technological characteristics as the predicate CUSA Clarity and CUSA Excel+ systems, including the predicate tip pack accessories. The primary modification of the subject tips compared to the predicate devices is that they are longer, in order to provide an alternate tip design suited for laparoscopic surgery to the CUSA Clarity portfolio. CUSA Clarity is already indicated for laparoscopic surgery. The purpose of the subject tips is to continue to fill out the CUSA Clarity Tip portfolio to align with that of the legacy CUSA Excel+ system and meet user needs; the CUSA Excel+ system has a tip design very similar to the subject tips. Additionally, testing confirmed that the modifications reduce the frictional force between a trocar and the flue as compared to the predicate CUSA Excel+ Laparoscopic Tip, making the device easier to insert and retract from the trocar during surgical use.
The provided text K221763 is a 510(k) summary for the CUSA® Clarity Ultrasonic Surgical Aspirator System, specifically for new 23kHz Laparoscopic Tip Packs. The submission claims substantial equivalence to predicate devices, and therefore, does not present a typical study with acceptance criteria and device performance analysis as one would expect for a de novo device or a device requiring clinical trials.
The document states: "No clinical studies were required or performed as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate devices." This means the FDA cleared the device based on non-clinical (bench) testing, demonstrating that it performs as intended and is as safe and effective as existing legally marketed predicate devices.
Therefore, the requested information, which typically pertains to studies proving a device meets acceptance criteria, is not fully applicable in the context of this 510(k) summary claiming substantial equivalence. However, I can extract the relevant information regarding the non-clinical testing performed and the conclusions drawn.
1. A table of acceptance criteria and the reported device performance
The document lists types of bench testing performed but does not explicitly provide a table of quantitative acceptance criteria and corresponding device performance results for each criterion. It broadly states that "Bench testing to verify requirements" was conducted.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied from the summary) |
|---|---|
| Sterilization, Shipping, and Stability | Met FDA guidance documents and recognized standards |
| Biocompatibility | Met FDA guidance documents and recognized standards |
| EMC and Electrical Safety | Met FDA guidance documents and recognized standards |
| Tissue Fragmentation Rate | Functionality within specification |
| Tip Life with CEM (Continuous Emulsification Mode) | Functionality within specification |
| Torque Functionality During Assembly | Functionality within specification |
| Functionality During Environmental Variations | Functionality within specification |
| Mechanical and Performance | Functionality within specification |
| Trocar-Flue Friction | Reduced frictional force between a trocar and the flue compared to predicate. Verified to make device easier to insert and retract. |
| Thermal Effects and Capacitive Coupling | Met FDA guidance document requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each non-clinical test. Given these are bench tests for substantial equivalence, the "data provenance" would be laboratory testing conducted by the manufacturer, Integra LifeSciences Corporation, in the USA.
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. For bench testing used in a 510(k) to demonstrate substantial equivalence, ground truth as established by human experts (e.g., radiologists) is not typically required. Performance is measured against engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable, as it pertains to human interpretation/adjudication of results, which was not part of this non-clinical testing.
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
This section is not applicable. No clinical or comparative effectiveness studies involving human readers or AI assistance were performed or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical aspirator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" refers to established engineering specifications, recognized industry standards (e.g., ISO for biocompatibility, IEC for electrical safety), and FDA guidance documents. Tissue fragmentation rate, tip life, and mechanical performance would be measured against internal design requirements and predicate device performance.
8. The sample size for the training set
This section is not applicable. This is not an AI/ML device, and therefore no "training set" of data was used.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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