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The ZEUS® Microwrist™ Robotic Surgical System is intended to assist in the accurate control of blunt dissectors, retractors, atraumatic graspers and stabilizers during laparoscopic and thoracoscopic surgery.

The users of the ZEUS® Microwrist™ Robotic Surgical System are surgeons trained in minimally invasive surgery. Assistant surgeons can also use this system while under the direction of the primary surgeon in accordance with hospital's customary practice.

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The provided text is a 510(k) summary for the ZEUS® MicroWrist™ Robotic Surgical System. It primarily focuses on the device's substantial equivalence to a previously cleared device (ZEUS® Robotic Surgical System K003431) and its compliance with various electrical and safety standards. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria related to its surgical assistance function.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that the device is "designed and tested to the following Computer Motion and voluntary standards," and then lists several electrical safety and EMC standards (EN60601-1, EN60601-1-1, EN60601-2-18, UL 2601-1, EN55011/A1, CISPR 11, EN61000-4-2, EN61000-4-3, EN50204, EN61000-4-4, EN61000-4-5, EN61000-4-6, CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92). These are safety and electromagnetic compatibility standards, not performance-based acceptance criteria for its surgical assistance capabilities.

The 510(k) process for this device relied on demonstrating substantial equivalence to a predicate device, which often means that extensive new clinical performance studies are not required if the new device does not raise new questions of safety and effectiveness. The summary primarily addresses safety and regulatory compliance rather than a detailed performance study against specific acceptance criteria for its intended use as a surgical assistant.

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