(76 days)
For transection, resection, and/or creation of anatomoses. The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter devices deliver two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows. A "no-knife" version may also be provided. The instrument's safety lock-out feature is designed to prevent a spent reload from being refired. Both the standard and the vascular/thin instruments have a staple line that is 20-60mm long and a cut line of 18-58mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. An articulation lever on the ETS-FLEX Endoscopic Articulating Linear Cutter enables bilateral movement of the instrument jaws. The instrument is reloadable with either a standard, blue reload for tissue that is compressible to 1.5mm in thickness, a thick, green reload for tissue that is compressible to 2.0mm in thickness, or a vascular/thin, white reload for tissue that is compressible to 1.0mm in thickness. Do not reload the instrument more than seven times for a maximum of eight firings per instrument.
This document does not contain information about an AI/ML device or its performance characteristics. The provided text is a 510(k) summary for a surgical stapling device, the ENDOPATH® ETS Endoscopic Linear Cutter.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone performance.
- Type of ground truth used (in the context of AI/ML).
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance data" section only states that "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in transecting, resecting, and/or creation of anastomoses." This is a general statement about the physical device's function, not a detailed breakdown of specific performance metrics or acceptance criteria as would be found for an AI/ML device.
§ 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.