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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The EndoWrist Mercury Bipolar Grasper is intended to be used with compatible systems for endoscopic manipulation of tissue, including dissection, grasping, retraction, and bipolar coagulation of tissue.

The EndoWrist Mercury Bipolar Grasper is a multiple-use, electrosurgical endoscopic instrument with a grasping tip to be used in conjunction with the da Vinci Xi (IS4000) and da Vinci X (IS4200) Systems and an external electrosurgical unit (ESU). Similar to the predicate device, the EndoWrist Mercury Bipolar Grasper consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. In addition, the subject Mercury Bipolar Grasper allows a user to select between two grip strength modes, DEFAULT and STRONG.

The provided document describes a 510(k) premarket notification for the "EndoWrist Mercury Bipolar Grasper" by Intuitive Surgical, Inc. It establishes substantial equivalence by comparing the new device to a predicate device ("EndoWrist Fenestrated Bipolar Forceps," K131861).

The document does not contain information about a study that proves the device meets specific quantitative acceptance criteria related to its performance in a clinical or AI-assisted setting, as would be expected for a product involving AI or requiring performance metrics beyond basic functional validation. The approval is based on demonstrating substantial equivalence to a predicate device through design verification and validation, focusing on physical, mechanical, electrical, user interface, and software specifications, as well as functional testing in animal and cadaver models.

Therefore, most of the requested information regarding acceptance criteria, AI performance, ground truth, and human reader studies cannot be extracted from this document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The primary acceptance criterion here is "substantial equivalence" to the predicate device. This is a regulatory standard for 510(k) submissions, meaning the device is as safe and effective as a legally marketed predicate device. Specific quantitative performance acceptance criteria are not detailed in this summary. The summary mentions that "design outputs meet the design inputs" and "the device performs as intended."

• Reported Device Performance: The document generally states that the device was evaluated through "Design Verification and Validation" to show that "the design outputs meet the design inputs and the device performs as intended." It specifies:

  • Bench tests: "confirmation that the device meets the physical, mechanical, electrical, user interface and software specifications."
  • Animal and Cadaver Tests: "confirm that the subject device functions in accordance with its intended use."

  No specific quantitative performance values (e.g., accuracy, sensitivity, specificity, or performance metrics related to a specific clinical task) are provided.

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

• Test Set (for performance validation): The document refers to "a series of bench tests" and "Tests with an animal model and a cadaver."
  • Sample Size: Not specified quantitatively (e.g., number of animals, number of cadavers, or number of tests performed).
  • Data Provenance: The document implies in-house testing ("Design Verification and Validation were performed on the subject Mercury Bipolar Grasper"). No information on geographical origin (country) or whether the data was retrospective or prospective is given, beyond indicating it was part of a design validation process. This type of testing is typically prospective.

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 and not required for this type of device (surgical instrument without AI component) or this type of regulatory submission (510(k) based on substantial equivalence to a predicate device, focusing on mechanical, electrical, and functional performance, rather than diagnostic accuracy requiring expert consensus). The "ground truth" for a surgical instrument's function is typically its ability to perform its intended mechanical and electrical actions without failure under various conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for this type of device and study. Adjudication methods are typically used in clinical studies assessing diagnostic or prognostic performance, often involving multiple readers.

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. This device is a surgical instrument, not an AI diagnostic/assistive tool, and no MRMC study or AI assistance is mentioned.

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

• Not applicable. This device is a surgical instrument that requires human operation (with robotic assistance), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance validation is its ability to meet engineering specifications (physical, mechanical, electrical, user interface, software) and to function as intended in simulated surgical environments (animal and cadaver models). This is a functional and safety "ground truth" rather than a clinical diagnostic "ground truth."

8. The sample size for the training set:

• Not applicable. This document is about a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable, as it's not an AI device.

In summary, the provided document is a 510(k) clearance letter for a surgical instrument, focusing on its substantial equivalence to a predicate device through engineering design verification and validation. It does not involve AI performance evaluation, clinical outcome studies, or expert consensus-based ground truth typical of AI/diagnostic device submissions.

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