(62 days)
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ENDOPATH ETS-Flex-45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex 45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
These instruments are all mechanical surgical stapling devices. The ENDOPATH Linear Cutter models are sterile single use instruments that deliver staples while simultaneously dividing tissue between rows. The ENDOPATH No-Knife Staplers are sterile single use instruments that deliver staples, but do not cut. These instruments may be used in either open or Endoscopic procedures, depending upon the design. Some instruments are Reloadable and, if so, they may be reloaded with various reloads (i.e., vascular/thin, standard, thick) depending on the thickness of tissue that is to be transected or resected.
The provided text is a 510(k) summary for the ENDOPATH® Endocutter Gray Cartridge, a surgical stapling device. This document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the way envisioned by your request for a medical device AI.
The document mainly focuses on the device's intended use, classification, and substantial equivalence to a predicate device. While it mentions "Bench testing and pre-clinical laboratory evaluations were performed to demonstrate that the device will perform as intended," it does not provide any specifics about these tests, methodologies, acceptance criteria, or results.
Therefore, I cannot provide the requested information in the format of your table and detailed points, as the necessary data is absent from the provided text.
The document does not describe the acceptance criteria and a study that proves the device meets those criteria.
Here's why and what information is missing:
- No Acceptance Criteria: The document does not list any specific performance metrics (e.g., accuracy, sensitivity, specificity, false positive rate) or associated thresholds that the device must meet to be considered acceptable.
- No Study Details: While "Bench testing and pre-clinical laboratory evaluations" are mentioned, no details are provided about:
- The specific tests conducted.
- The results of these tests.
- The methodologies used.
- The sample sizes.
- The ground truth establishment.
- Any involvement of experts.
- Any comparison with human performance or a "gold standard."
Summary of missing information based on your requested points:
- Table of acceptance criteria and reported device performance: Not available. No acceptance criteria or specific performance data is reported.
- Sample size used for the test set and data provenance: Not available. No details on test sets or data provenance are provided.
- Number of experts used to establish the ground truth for the test set and qualifications: Not available. No mention of experts or ground truth establishment.
- Adjudication method for the test set: Not available.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not available. The device is a mechanical stapling device, not an AI or imaging device that would typically undergo MRMC studies with human readers.
- Standalone performance (algorithm only without human-in-the-loop performance): Not available. The device is a mechanical surgical instrument, not an AI algorithm.
- Type of ground truth used: Not available.
- Sample size for the training set: Not applicable/Not available. This is a mechanical device, not an AI model that would have a training set.
- How the ground truth for the training set was established: Not applicable/Not available.
In essence, the provided text is a regulatory filing for a physical medical device (surgical stapler) and not a scientific study report about an AI-powered diagnostic or predictive tool. Therefore, it does not contain the kind of performance data and study details you're looking for, which are typically associated with the validation of AI/ML-enabled medical devices.
§ 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.