(155 days)
The ZEUS® Microwrist™ Robotic Surgical System is intended to assist in the accurate control of blunt dissectors, retractors, atraumatic graspers and stabilizers during laparoscopic and thoracoscopic surgery.
The users of the ZEUS® Microwrist™ Robotic Surgical System are surgeons trained in minimally invasive surgery. Assistant surgeons can also use this system while under the direction of the primary surgeon in accordance with hospital's customary practice.
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The provided text is a 510(k) summary for the ZEUS® MicroWrist™ Robotic Surgical System. It primarily focuses on the device's substantial equivalence to a previously cleared device (ZEUS® Robotic Surgical System K003431) and its compliance with various electrical and safety standards. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria related to its surgical assistance function.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that the device is "designed and tested to the following Computer Motion and voluntary standards," and then lists several electrical safety and EMC standards (EN60601-1, EN60601-1-1, EN60601-2-18, UL 2601-1, EN55011/A1, CISPR 11, EN61000-4-2, EN61000-4-3, EN50204, EN61000-4-4, EN61000-4-5, EN61000-4-6, CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92). These are safety and electromagnetic compatibility standards, not performance-based acceptance criteria for its surgical assistance capabilities.
The 510(k) process for this device relied on demonstrating substantial equivalence to a predicate device, which often means that extensive new clinical performance studies are not required if the new device does not raise new questions of safety and effectiveness. The summary primarily addresses safety and regulatory compliance rather than a detailed performance study against specific acceptance criteria for its intended use as a surgical assistant.
§ 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.