Search Results

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 < 3cm
  • (b) Bleeding ulcers
  • (c) Arteries < 2 mm
  • (d) Polyps < 1.5 cm in diameter
  • (e) Diverticula in the colon
• (3) Anchoring to affix jejunal feeding tubes to the wall of the small bowel
• (4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively

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.

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.

Ask a specific question about this device

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 < 3cm
• (b) Bleeding ulcers
• (c)Arteries < 2 mm
• (d)Polyps < 1.5 cm in diameter
• (e)Diverticula in the colon
• (3) Anchoring to affix jejunal feeding tubes to the wall of the small bowel
• (4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively

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.

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.

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:

2. Sample Size Used for the Test Set and Data Provenance

The document describes design verification and validation testing and biocompatibility testing, but these are not clinical studies in the typical sense with patient test sets.

• Test Set Sample Size: No mention of a "test set" in terms of subject or image count for an AI or diagnostic device. The testing described focuses on device components and their physical/chemical properties.
• Data Provenance: Not applicable in the context of device component and materials testing. The testing was conducted in 2018 for biocompatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The described testing involves laboratory and engineering evaluations, not clinical adjudication by experts.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document describes a device (ClearEndoclip) rather than an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned. This is a medical device clearance, not an AI software clearance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This document pertains to a physical medical device (endoscopic clip) and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed appears to be:

• Biocompatibility: Conformance to ISO 10993-1: 2009 standards and demonstrating a safety profile equivalent to the predicate device.
• Design Verification & Validation: Meeting pre-defined safety and performance requirements, matching design inputs with outputs, and effectiveness of risk mitigation measures (ISO 14971:2012).
• Performance Tests (Appearance, Dimension, Rotation, etc.): Presumably established engineering specifications and comparison to the performance of the predicate device.
• Physicochemical Testing: Established analytical methods and safety profiles for extractable substances.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there's no training set mentioned for an AI/ML device, this question is not relevant.

In summary: The provided text describes the 510(k) clearance for a physical medical device, the ClearEndoclip, which is an endoscopic clipping device, not an AI or software device. The "study" described consists of engineering and biocompatibility testing to demonstrate substantial equivalence to a predicate device and compliance with recognized standards. It does not involve clinical trials with human subjects or AI performance metrics.

Ask a specific question about this device