(167 days)
The ZEUS® MicroWrist "Surgical System (ZEUS System) and Accessories are intended to be used to assist a surgeon during procedures such as Laparoscopic Cholecystectomy and Nissen Fundoplication, to hold and position an endoscope, and to control laparoscopic instruments in performance of the surgical tasks of grasping, sharp cutting, blunt dissection, electro-cautery and suturing with knot placement. The ZEUS System is intended to be used by surgeons who are trained in minimally invasive surgery, have successfully completed a ZEUS System training program, and are certified in accordance with their respective hospital's customary practice for ZEUS System use. The ZEUS® MicroWrist™ Surgical System is intended to be used in an operating room environment in which the ZEUS System, the operating surgeon and patient are in the same room.
The ZEUS® MicroWrist™ Surgical System (ZEUS System) and Accessories, 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 HERMESTM Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS® MicroWrist™ Surgical System and Accessories, and has been cleared to operate with many ancillary devices.
The provided text is a 510(k) summary for the ZEUS® MicroWrist™ Surgical System and Accessories. While it outlines the device's intended use, safety standards, and mentions clinical trials, it does not contain specific acceptance criteria or detailed results of a study that directly prove the device meets such criteria in a quantitative manner (e.g., sensitivity, specificity, or surgical success rates with defined thresholds).
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The clinical trials are described as comparative effectiveness studies against standard laparoscopic surgery, proving safety and effectiveness for a new indication for use based on overall outcomes rather than pre-defined performance metrics for the device itself.
Therefore, much of the requested information cannot be extracted directly from this document. I will fill in what is available and indicate when information is "Not provided in the text."
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Safety: Device is safe for intended use. | Demonstrated by "extensive, prospective, randomized, concurrently controlled clinical trials" with over 200 patients; hazardous analysis completed. | The document asserts safety was demonstrated but does not specify quantitative criteria (e.g., adverse event rates below a certain threshold). |
| Effectiveness: Device is effective for intended use (e.g., assisting surgeons in Laparoscopic Cholecystectomy and Nissen Fundoplication). | Demonstrated by "extensive, prospective, randomized, concurrently controlled clinical trials" with over 200 patients, showing "consistent ability and time to complete a task and procedure successfully." | The document asserts effectiveness was demonstrated but does not specify quantitative criteria (e.g., successful procedure rates, completion times, surgical outcomes with defined thresholds). |
| Substantial Equivalence: Device is substantially equivalent to predicate devices. | The ZEUS System and Accessories were found substantially equivalent to a standard laparoscope with hand-held instruments and the Intuitive Surgical da Vinci System based on non-clinical and clinical data. | This is the primary conclusion of the 510(k) submission. |
| Learning Curve: Surgeons trained in the ZEUS System and minimally invasive surgery can achieve proficiency. | Experienced a "minimum 13-case learning curve to approximate procedure time with control" for highly selected uncomplicated Laparoscopic Cholecystectomy and Laparoscopic Nissen Fundoplication. | This is a specific metric reported from the clinical trials but is not presented as a pre-defined acceptance criterion. |
Study Information
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Sample size used for the test set and the data provenance:
- Sample size: "over 200 patients" across two extensive clinical trials.
- Data provenance: Not explicitly stated, but the submission is to the US FDA, so the trials would likely have been conducted, at least in part, in the US or under protocols acceptable to the FDA. The trials were "prospective, randomized, concurrently controlled."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided in the text. The clinical trials compared the ZEUS system to standard laparoscopic surgery. The "ground truth" here would likely be the patient outcomes and surgical success as determined by the operating surgeons and follow-up, rather than individual expert adjudication of data derived from the device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in the text. Clinical trials usually involve assessment by the operating team and follow-up clinicians, but a specific adjudication method for study endpoints (like 2+1 review for image-based diagnostics) is not mentioned.
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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:
- This was a comparative effectiveness study, comparing the ZEUS system (a surgical robot assisting the surgeon) to standard laparoscopic surgery. It was not a "multi reader multi case" study in the typical diagnostic AI sense.
- The study design was "two extensive, prospective, randomized, concurrently controlled clinical trials" comparing the ZEUS system to standard laparoscopic surgery.
- Effect size of human readers improvement with AI (robot) vs. without AI (robot) assistance: The document states that "surgeons trained in the ZEUS System and minimally invasive surgery experienced a minimum 13-case learning curve to approximate procedure time with control." This indicates that with training on the ZEUS system, surgeons could achieve similar procedure times to standard methods. It doesn't quantify improvement over unaided human performance in a general sense, but rather comparative performance after a learning curve. No specific effect size (e.g., mean procedural time reduction) is given in the summary beyond the learning curve observation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this device is explicitly designed as a surgeon's assistant ("assist a surgeon"), so a standalone algorithm-only performance study would not be relevant or possible given its nature as a surgical manipulation system. The "human-in-the-loop" (the surgeon) is integral to the device's function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical trials, the ground truth would be patient outcomes and successful completion of surgical procedures (Laparoscopic Cholecystectomy and Nissen Fundoplication) as evaluated by clinical criteria, surgical reports, and post-operative follow-up.
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The sample size for the training set:
- Not applicable in the typical sense of machine learning model training data. This device is a surgical system, not an AI diagnostic algorithm trained on a dataset. The "training" mentioned refers to the surgeon's training on how to use the device, not the device's algorithmic training.
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How the ground truth for the training set was established:
- Not applicable for the reasons mentioned above.
§ 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.