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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, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain 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

The device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The purpose of this submission is to modify the CEM nosecone accessory currently offered with CUSA Clarity to allow for connection with additional electrosurgical generators, to continue to provide electrosurgical capabilities to the user. The additional electrosurgical generators that the modified CEM Nosecone may be used with include the Medtronic FT10 (K191601), Medtronic FX8 (K181389), Erbe VIO 300D (K083452), and Erbe VIO 3 (K190823). Compatibility with the Medtronic Force FX (K143161) will be maintained as well.

The CUSA Clarity 23kHz Expanded CEM Nosecone has the same intended use and technological characteristics as the predicate CUSA Clarity 23 kHz CEM Nosecone (K190180). The subject CEM nosecone will continue to allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue.

The provided text describes the CUSA Clarity Ultrasonic Surgical Aspirator System, specifically focusing on a modified CEM nosecone accessory for the 23 kHz components. This submission is a 510(k) premarket notification claiming substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes various non-clinical tests undertaken to ensure the safety and efficacy of the device and its substantial equivalence to the predicate.

The reported device performance is broadly stated as:

• "Testing was determined successful and supports the conclusion that all product specifications and design inputs have been met."
• "The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology, and performance of the CUSA Clarity 23 kHz Expanded CEM Nosecone is substantially equivalent to the predicate device."

Therefore, a table of quantitative acceptance criteria and specific reported device performance cannot be generated from the provided text. The information indicates that all tests were passed and specifications met, implying the device performed within acceptable limits.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing but does not specify a "test set" in terms of subject or patient data. The tests are focused on device characteristics rather than clinical outcomes with a patient population.

• Sample size for test set: Not applicable in the context of device performance testing described. The tests are on the device itself (e.g., handpiece life, functionality, mechanical properties).
• Data provenance: Not applicable in the context of patient data. The provenance is from internal testing conducted by Integra LifeSciences Corporation. There is no mention of country of origin for data related to clinical or patient studies, as none were performed. The tests are prospective as they were conducted as part of the submission process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of experts: Not applicable. The "ground truth" for the non-clinical tests is established by engineering specifications, recognized standards (FDA guidance documents, ISO standards for biocompatibility, EMC, and electrical safety), and comparison to the predicate device's established performance.
• Qualifications of experts: Not specified as a separate set of experts for ground truth. However, the development and testing would have been overseen by Integra LifeSciences Corporation's engineering and regulatory teams.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. The testing described is objective device performance (e.g., sterilization, biocompatibility, electrical safety, mechanical, thermal effects). Success or failure is determined by meeting predefined engineering specifications and regulatory standards, not by an adjudication process between human experts on a specific outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No. The document 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 device."
• Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study or study involving human readers with or without AI assistance was conducted. The device is a surgical aspirator system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone study: Not applicable. The CUSA Clarity Ultrasonic Surgical Aspirator System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on:

• Established engineering specifications and design inputs: Ensuring the device functions as intended.
• Compliance with FDA guidance documents and recognized standards: Such as those for sterilization, biocompatibility, EMC, electrical safety, thermal effects, and capacitive coupling.
• Substantial equivalence to the legally marketed predicate device (CUSA® Clarity Ultrasonic Surgical Aspirator System K190180): This implies that the predicate's established safety and effectiveness profile serves as a benchmark for the new component.

8. The Sample Size for the Training Set

• Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is assessed through traditional engineering and regulatory compliance testing.

9. How the Ground Truth for the Training Set Was Established

• How ground truth for training set was established: Not applicable, as there is no training set for this type of device.

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The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab FX8 FX Series Energy Platform is a radio-frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the tip of the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation, sealing). Variations in the waveform result in the different surgical effects achieved by different modes.

The provided text describes a 510(k) premarket notification for the Valleylab FX8 FX Series Energy Platform, an electrosurgical generator. The submission aims to demonstrate substantial equivalence to a predicate device, the Valleylab FT10 Energy Platform.

However, the documentation does not include a study proving the device meets specific performance acceptance criteria in the way one might expect for an AI/ML medical device, which would typically involve metrics like sensitivity, specificity, or AUC against a ground truth.

Instead, the provided text describes the verification and validation activities performed to demonstrate that the Valleylab FX8 FX Series Energy Platform performs as intended and is substantially equivalent to its predicate. These activities focus on safety, functionality, and performance equivalence, rather than a clinical effectiveness study with human readers or a standalone algorithm.

Here's a breakdown based on the information available, addressing the requested points:

Acceptance Criteria and Device Performance Study (as described in the document)

The document primarily focuses on demonstrating substantial equivalence through engineering and laboratory testing, rather than a clinical performance study with defined "acceptance criteria" and "reported device performance" in terms of classification metrics (e.g., sensitivity, specificity) against a clinical ground truth.

The "acceptance criteria" for this device are implicitly tied to:

• Compliance with specific electrical safety and EMC standards.
• Comparable performance to the predicate device in ex vivo tissue testing.
• Meeting system specifications.
• Successful software verification and validation.

1. Table of acceptance criteria and reported device performance:

Based on the provided text, a table like this would represent the types of tests done and the general outcomes, rather than quantitative performance metrics against a clinical outcome.

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

• Test Set Sample Size: Not specified quantitatively. The ex vivo testing mentions "porcine tissue" but does not give a sample size (e.g., number of tissue samples, number of tests performed).
• Data Provenance: The ex vivo testing was performed using "porcine tissue," implying a laboratory setting. The country of origin and whether it was retrospective or prospective is not stated, but it's clearly a controlled, pre-market lab-based testing scenario, not a retrospective analysis of clinical patient data.

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

• Not Applicable. For this type of electrosurgical generator, "ground truth" concerning thermal effects or system functionality would be established through physical measurements, engineering specifications, and validated test methods, not by expert consensus on clinical images or diagnoses.

4. Adjudication method for the test set:

• Not Applicable. As there are no human experts classifying outcomes on a test set, no adjudication method (like 2+1 or 3+1) was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study was explicitly not performed. The document states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This type of study is typically done for diagnostic AI devices, not electrosurgical generators.

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

• No, not in the context of an AI algorithm. This device is an electrosurgical generator, not a diagnostic algorithm. Its "performance" is evaluated based on its physical characteristics, energy delivery, safety, and functionality, not its ability to interpret data independently.

7. The type of ground truth used:

• For electrical safety and EMC: Engineering standards and measured electrical characteristics.
• For ex vivo testing: Physical measurements of thermal effects on porcine tissue.
• For system verification: Engineering specifications and functional tests.
• For software: Software requirements, design specifications, and standard software quality assurance testing.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that uses a "training set" in the conventional sense. The device's "training" is its design, engineering, and manufacturing process.

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

• Not Applicable. As this is not an AI/ML device, there is no "training set" or ground truth for it. Its operational parameters are determined by electrosurgical principles and engineering design.

In summary: The provided document is a 510(k) summary for an electrosurgical generator, which is a physical medical device, not a software algorithm or AI-powered diagnostic tool. Therefore, the "study that proves the device meets the acceptance criteria" is fundamentally different from what would be expected for an AI/ML product. The "acceptance criteria" discussed are related to engineering and safety standards, and performance equivalence to a predicate device, rather than diagnostic accuracy metrics.

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