(306 days)
The Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical EndoWrist Stapler 45 System when used with the compatible Stapler 45 Reloads delivers multiple rows of staples and transects the tissue along the middle of the staple line. The EndoWrist Stapler 45 System is a reusable device and the Stapler 45 Reloads (available in various sizes) are single-use/disposable devices.
The provided document is a 510(k) summary for the Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads, a surgical stapler. It describes the device, its intended use, and states that performance data (bench and animal tests) demonstrate substantial equivalence to a predicate device. However, it does not contain the specific details required to answer the questions about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth methods.
The document states: "Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." This statement indicates that studies were performed, but the specifics of those studies are not included in this summary.
Therefore, I cannot provide the requested information from the given text.
Here's what the document does tell us, and why the other information is missing:
- Acceptance Criteria & Reported Performance: The document only states that "design output meets the design input requirements" and that the device is "substantially equivalent" to the predicate. It does not provide a table of specific acceptance criteria or detailed performance metrics.
- Sample Size (Test Set) & Data Provenance: Not mentioned. The studies are referred to generally as "bench and animal tests."
- Number of Experts & Qualifications: Not applicable for bench/animal tests of a surgical stapler's mechanical performance.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable to a surgical stapler's performance. This type of study is typically for evaluating diagnostic imaging or AI systems where human reader performance is a key metric.
- Standalone Performance: The performance data would inherently be "standalone" for the device itself, but specific metrics are not provided.
- Type of Ground Truth: For a surgical stapler, "ground truth" would likely involve objective measurements of staple formation, tissue integrity, leak pressure, etc., established during bench and animal testing. However, the exact methods are not detailed.
- Sample Size (Training Set): Not applicable for this type of device. "Training set" refers to data used to train AI/machine learning models, which is not relevant here.
- How Ground Truth for Training Set was Established: Not applicable.
§ 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.