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ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is preloaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.

ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.

AI/ML Overview

The provided text describes Finemedix Co., Ltd.'s ClearEndoclip, a medical device for endoscopic clipping. However, it does not contain information about software or AI, nor does it discuss acceptance criteria and study results related to AI device performance. The document is a 510(k) summary for a physical medical device, focusing on its substantial equivalence to a predicate device, functional descriptions, indications for use, and performance data related to its MR (Magnetic Resonance) compatibility.

Therefore, I cannot fulfill your request as the necessary information regarding AI device performance, study types (MRMC, standalone), ground truth establishment, training set details, and expert involvement is not present in the provided text.

The "Performance Data" section specifically details tests for MR compatibility (e.g., magnetically induced displacement force, torque, image artifact, RF induced heating, and MR pull-off test), all of which relate to the physical properties of the clip in an MRI environment, not the performance of an AI algorithm.

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K Number

K183021

Device Name

ClearEndoclip

Manufacturer

Finemedix Co., Ltd.

Date Cleared

2019-06-28

(239 days)

Product Code

PKL,FHN,MND

Regulation Number

876.4400

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

K013066,K123601

Intended Use

ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for

(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects

Device Description

ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is pre-loaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information for the ClearEndoclip device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative performance metrics like sensitivity, specificity, accuracy, or a pass/fail percentage for a diagnostic or AI-driven device.

Instead, the performance data section focuses on demonstrating conformance to established standards and comparing the device's characteristics to a predicate device. The general acceptance criterion seems to be "demonstrates equivalent safety and performance profile as the predicate device" and "conformance to the appropriate recognized standards of FDA, ISO 10993-1 (2009)."

Here's a summary of the performance claims:

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility	Favorable biocompatibility test results drawn in 2018 testing, ensuring FDA's latest consensus standards (ISO 10993-1: 2009) are met. Classified as "Implant Device - Tissue/bone/dentin (Prolonged contact duration)" for the clip and "Externally Communicating Devices (

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