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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci 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 subject IS4000 Small Clip Applier Instrument and IS4000 Long Bipolar Grasper Instrument are to be used with the IS4000 da Vinci Surgical System. The subject instruments consist of the housing, shaft, wrist, and tip. The housing contains the connection mechanism to the IS4000 da Vinci Surgical System arm. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. These instruments are reusable and provided non-sterile.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance.

The document is a 510(k) premarket notification letter from the FDA to Intuitive Surgical Incorporated regarding the IS4000 Small Clip Applier and Long Bipolar Grasper. It primarily discusses:

• Device identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
• Substantial Equivalence: Comparing the subject devices to predicate devices (K131861 - IS4000 Small Clip Applier and K131861 - IS4000 Fenestrated Bipolar Forceps).
• Modifications: Geometrical changes to the instrument jaws for compatibility and additional dissecting options.
• Performance Data: Mentions "Design verification" and "Design validation" testing to confirm design outputs meet requirements and that the instruments are safe and effective.
  • Design Verification included bench testing for reliability, durability, leakage, range of motion, jaw positions, friction, torque, instrument insertion, and labeling adequacy. It also covered software compatibility and instrument data verification.
  • Design Validation involved evaluating general, functional, and compatibility requirements in "representative simulated clinical settings that utilized porcine (in vivo) and cadaveric tissue models."

This document focuses on the mechanical and functional performance of surgical instruments, not on diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with AI/ML diagnostic tools as you've requested. Therefore, I cannot extract the information required for the table and bullet points regarding acceptance criteria, study details, ground truth, or expert involvement for AI/ML performance.

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