(30 days)
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.