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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.

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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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.

Ask a specific question about this device

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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