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The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
• Neurosurgery • Gastrointestinal and Affiliated Organ Surgery • Urological Surgery • Plastic and Reconstructive Surgery • General Surgery • Orthopedic Surgery • Gynecological Surgery • Thoracic Surgery • Laparoscopic Surgery • Thoracoscopic Surgery

The CUSA Excel+ Ultrasonic Surgical Aspirator System is the current iteration of the previously cleared CUSA Excel Ultrasonic Surgical Aspirator System. Both product lines are owned by Integra LifeSciences; only the CUSA Excel+ is currently marketed in the United States. Like the CUSA Excel, the CUSA Excel+ is an ultrasonically vibrating surgical device which, in combination with irrigation, and aspiration, fragments, emulsifies and removes unwanted tissue. Minor modifications have been made to the device since the original CUSA Excel was cleared. The intended use and the fundamental scientific technology of the CUSA Excel+ are the same as the CUSA Excel.

This document is a 510(k) premarket notification for the CUSA® Excel+ Ultrasonic Surgical Aspirator System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain the specific information requested about acceptance criteria, device performance, and the details of a study proving those criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document describes modifications to an existing device and tests to ensure safety and effectiveness after modifications, but it does not specify performance acceptance criteria or report a study's performance against them.
2. Sample size used for the test set and the data provenance: No information on a test set (e.g., patient data) for performance evaluation is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no performance evaluation test set described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no performance evaluation test set described.
8. The sample size for the training set: Not applicable as there's no machine learning model or training set discussed.
9. How the ground truth for the training set was established: Not applicable.

The document states that "Non-clinical testing was performed to support modifications, ensuring the safety and effectiveness was maintained following device modifications." The tests listed are:

• Sterilization validations
• Electromagnetic Compatibility and Electrical Safety testing
• Noise reduction testing
• Non-patient contacting material change testing
• Power supply re-work testing

These tests are to ensure the modified device performs comparably to the predicate device and meets general safety standards, not to establish performance criteria for a novel diagnostic or AI device.

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