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The Bipolar Grasper and Bipolar Scissors are instruments used with the ZEUS® MicroWrist™ Surgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System.

This premarket notification adds a bipolar grasper and bipolar scissors to the ZEUS® MicroWrist™ Surgical System. These surgical instruments are used in conjunction with an electrosurgical generator unit (ESU), and they augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System. These devices are additions to the MicroAssist 100 line of ZEUS surgical instruments. MicroAssist instruments consist of commercially available hand-held devices that have been modified in order to be attached to the ZEUS arm. As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version. The ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner which provides the surgeon with a steady view of the internal operating field. The HERMES® O.R. Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS System.

The provided document describes a 510(k) summary for Bipolar Grasper and Bipolar Scissors for the ZEUS® MicroWrist™ Surgical System. This submission focuses on establishing substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined performance metrics.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not applicable to this type of regulatory submission. The document reports on non-clinical tests to demonstrate substantial equivalence, not a clinical trial with specific performance endpoints.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A) in the context of specific performance metrics.

This 510(k) submission is for substantial equivalence. The "acceptance criteria" are implicitly met by demonstrating that the new devices are "substantially equivalent in terms of size, shape, function, activation, and intended use to the predicate devices cited." The "reported device performance" is that these characteristics are maintained, even when manipulated by the robotic system.

Also: "As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version."

Conclusion: "Data provided in this submission indicate that the basic functional characteristics of these devices are substantially equivalent to the predicates." |

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

Not directly applicable as a clinical "test set" demonstrating performance metrics.

The submission relies on non-clinical tests to establish substantial equivalence. The document does not specify a "sample size" for a test set in the way one would for a clinical performance study (e.g., number of patients or cases). The "data provenance" would be from internal engineering and bench testing, likely conducted by Computer Motion, Inc. There is no mention of country of origin for clinical data.

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

N/A. Ground truth from clinical experts is not relevant here as it's not a clinical performance study. The "ground truth" for substantial equivalence is based on engineering specifications and physical characteristics compared to predicate devices.

4. Adjudication Method for the Test Set

N/A. No adjudication method is described as there isn't a clinical test set requiring expert review or consensus.

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

N/A. This device is a surgical instrument (bipolar grasper and scissors), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.

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

N/A. This device is a surgical instrument that is part of a surgical system controlled by a human surgeon (“ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments”). It is not an algorithm, and the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:

• Engineering specifications and design characteristics of the new devices (Bipolar Grasper and Bipolar Scissors).
• Comparison to the known specifications and performance of the predicate hand-held devices (Lyons™ Dissecting Forceps and Evershears®).
• The fact that "the distal end that is used to perform surgical tasks remains unchanged from the hand-held version" implies that the functional part of the device is identical to established predicate devices.

8. The Sample Size for the Training Set

N/A. As this is a 510(k) for surgical instruments demonstrating substantial equivalence through non-clinical testing, there is no "training set" in the context of machine learning or AI.

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

N/A. See point 8.

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