(90 days)
The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.
The device is an endoscopic accessory designed to provide external support to and maintain a path for an endoscope to minimize the formation of gastric looping by the endoscope and to minimize mucosal pinching, while inserting, advancing, and removing the endoscope during endoscopic procedures in the upper gastrointestinal tract, including the small intestine. The device is intended for prescription use, is non-sterile, is intended for single use, and is not intended for reprocessing.
The provided text describes a 510(k) Premarket Notification for an "Enteroscopy Overtube." It outlines the device's purpose, classification, predicate devices, and indications for use. However, it explicitly states that "Performance testing consisted of functional bench testing" and does not include any information about clinical studies with human subjects, AI performance, or the establishment of ground truth in the context of diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria, statistical studies, ground truth establishment, or AI-related metrics cannot be extracted from this document.
Here's a breakdown of the information that can and cannot be provided based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific acceptance criteria in a quantifiable manner, nor does it report specific performance metrics from functional bench testing. It broadly states: "Performance testing consisted of functional bench testing. All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing mentioned is "functional bench testing," which implies testing of the device's physical properties and functionality, not a clinical test set with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. "Ground truth" in the context of diagnostic accuracy is not relevant for a functional bench test of a physical medical device.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC study was mentioned, nor is there any mention of AI in the document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance was mentioned, as the device is a physical medical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
For the "functional bench testing," the "ground truth" would be engineering specifications and design requirements that the device must meet (e.g., tensile strength, flexibility, dimensions, ease of insertion/removal of endoscopes, minimization of looping and pinching). However, these specific specifications are not detailed in the provided text. No ground truth related to clinical outcomes or diagnostic accuracy in human subjects is mentioned.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The product is a physical device, and the testing described is functional bench testing. There is no mention of a "training set" in the context of an algorithm or diagnostic study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
§ 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.