(268 days)
The Lumendi DiLumen C1 and EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
The DiLumen C1 and EZ1 consists of a sleeve with an inflatable balloon at the distal end that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The DiLumen C1 includes an attached flexible tool channel to allow endoscopic tools to be inserted through it and used in conjunction with the endoscope. The DiLumen EZ1 does not have the tool channel. The C1 and EZ1 are provided non-sterile and do not require disinfection or sterilization prior to use. The devices are intended only for single patient use.
To stabilize the system during clinical use, the C1 is used with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channel to a surgical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling. As the EZ1 does not have a tool channel, the Tool Mount is not used to perform its intended functions.
The provided text is a 510(k) summary for the Lumendi DiLumen C1, EZ1, and Tool Mount device. It outlines the product, its intended use, and its substantial equivalence to a predicate device (Lumendi DiLumen C2 and Tool Mount). However, it does not contain the specific information required to answer your questions about acceptance criteria, study details, human reader performance, or ground truth establishment for AI-related studies.
This document describes a medical device clearance process based on substantial equivalence to an already cleared predicate device, not on the performance of a novel AI algorithm tested against specific ground truth data with human readers. The performance data section refers to bench testing for mechanical integrity and usability of the physical device, not an AI model's diagnostic accuracy or its impact on human performance.
Therefore, I cannot provide the requested information from the given text. The text does not describe:
- A table of acceptance criteria and reported device performance related to an AI model. The acceptance criteria here are about physical device specifications (e.g., balloon integrity, insertion force), not AI metrics like sensitivity or specificity.
- Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods for an AI study. The "test set" mentioned refers to physical units undergoing bench tests.
- MRMC comparative effectiveness study, effect size of human reader improvement with AI assistance, or standalone AI performance. This is a hardware device, not an AI diagnostic tool.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI model.
- Sample size for a training set or how ground truth for a training set was established for an AI model.
The "Performance Data" section lists several bench tests:
- Instrument Insertion Force Test
- Tool Channel Separation Force
- Balloon Leak Force/Bond Leak Testing
- Colon Grip Test
- Fatigue/Cycling and System Leakage Test
- Balloon Scope Centering Test
- User Verification Test (Device Usability)
The conclusion states: "In all instances, the device functioned as intended and the results observed were as expected." This indicates that the device met its pre-defined specifications for these physical and mechanical tests, which serves as the "acceptance criteria" for this type of device and submission. However, these are not the kind of "acceptance criteria" typically associated with AI/ML 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.