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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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The CUSA Excel 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, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.

The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) 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 Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.

The provided text is a 510(k) summary for the Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), sample sizes for test sets or training sets, expert qualifications, adjudication methods, or results from comparative effectiveness studies.

The text simply states: "Testing was completed to demonstrate that the tip will abrade bone." This is a general statement and does not provide quantified performance data or details of a study that would establish specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information required for the table and all the numbered points because the provided document does not contain this type of performance study data.

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