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The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance Articulating platform is intended as an addition to the suite of instruments and adapters previously cleared for use with the Senhance® Surgical System ("Senhance system"). These instruments add degrees of freedom near the instrument end effector to allow for additional range of motion for the surgeon when performing laparoscopic tissue manipulations. Two articulating instruments are being added to the suite of instruments –Bipolar Atraumatic Grasper and Needle Driver. The instruments are single use and provided sterile to the end user. The instruments connect to a coupler which in turn connects to the articulating adapter which attaches to the Senhance Manipulator Arm.

The provided text, a 510(k) summary for the Senhance Surgical System, describes the device, its intended use, and substantial equivalence to predicate devices, supported by various performance tests. However, it does not contain the specific information required to complete a table of acceptance criteria and the detailed study results as requested in the prompt.

Specifically, the document does NOT include:

• A table of acceptance criteria with reported device performance (quantitative metrics are absent). The document mentions various performance tests (Biocompatibility, Reprocessing, Bench Testing, Electrical Safety, Software V&V, Pre-Clinical Design Validation, Usability Testing) but provides only qualitative statements about their success (e.g., "demonstrated that the patient-contacting portions... are non-toxic," "confirmed that the articulating instruments perform as intended," "Software verification and validation were successfully conducted," "All applicable user level requirements were assessed and found to be met," "The surgical teams were able to independently perform all critical tasks without use errors that would lead to harm"). It does not list specific numerical acceptance thresholds or the measured device performance against those thresholds.
• Sample sizes used for a "test set" in the context of AI/ML performance. While "Pre-Clinical Design Validation" involved a "simulated use design validation evaluation" with "users who represented the intended primary user population," and "Usability Testing" involved "surgical teams," these are not described as conventional "test sets" for evaluating an AI/ML algorithm's analytical performance (e.g., in terms of sensitivity/specificity).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Details on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or effect size of human reader improvement with AI assistance. The device described is a surgical system with articulating instruments, not an AI software intended to assist human readers in, for example, diagnostic image interpretation.
• Details on a standalone (algorithm only) performance study. Again, this is a surgical system, not an AI algorithm evaluated in isolation.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Conclusion:

The provided document describes the regulatory submission for a surgical system, focusing on its substantial equivalence to a predicate device through various engineering and usability validations. It does not provide the specific type of information requested, which pertains more to the rigorous testing and validation of an Artificial Intelligence/Machine Learning (AI/ML) based medical device, particularly in a diagnostic or assistive interpretive role, where concepts like acceptance criteria for sensitivity/specificity, ground truth establishment by experts, and MRMC studies are common. The device described, the "Senhance Surgical System," is a robotically-assisted surgical tool with new articulating instruments, not an AI/ML diagnostic or predictive software.

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