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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:

1. 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.
2. 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.
3. 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.
4. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI model.
5. 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.

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