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The Single Use Reloadable Clip Applicators and Clips have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of
(1) Endoscopic marking,
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects < 3 cm,
(b) Bleeding ulcers,
(c) Arteries < 2 mm,
(d) Polyps < 1.5 cm in diameter.
(e) Diverticula in the colon,
(3) As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

The Single Use Reloadable Clip Applicators and Clips have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of
(1) Endoscopic marking,
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects < 3 cm,
(b) Bleeding ulcers,
(c) Arteries < 2 mm,
(d) Polyps < 1.5 cm in diameter,
(e) Diverticula in the colon,
(3) As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
The subject devices are composed of the applicator and clip. The devices are used in a combined state. The clip that is attached to the applicator is controlled by the operator using the slider. The clip opens to the maximum opening width when the slider of the applicator is pulled towards the operator. Clipping is achieved when the slider of the applicator is pulled completely and the portion of the clip connector is broken. Upon completion, the clip and the applicator are no longer connected. Once the clipping is performed, the closure force of clips remains in place until tissue necrosis occurs, and the clip is excreted naturally.

This is a traditional 510(k) submission for a medical device (Single Use Reloadable Clip Applicators and Clips) and not an AI/ML medical device. Therefore, the information regarding acceptance criteria and study proving AI/ML device performance (e.g., sample size, expert ground truth, MRMC studies) is not applicable or present in the provided text.

The provided document describes the predicate device and the new device, and focuses on demonstrating substantial equivalence primarily through non-clinical performance data (sterilization/shelf life, biocompatibility, and bench testing). No clinical or animal studies were conducted.

Here's how the provided information relates to your request, with a clear indication of what is not present because it's not an AI/ML device:

1. A table of acceptance criteria and the reported device performance:

The document mentions that "The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment" (Section 5.7 (6)). However, it does not provide a specific table laying out the acceptance criteria and the reported performance results for each test. It lists the types of performance tests conducted:

• Performance Tests Performed (Bench Testing):
  • Insertability
  • Clip opening width
  • Clip rotatability
  • Clip capability
  • Withdrawal from endoscope
  • Applicator repetition
  • Endoscope compatibility
  • Clip tail length
  • Retention capability
  • MRI testing
  • Package integrity testing
  • Mechanical testing

The document states these tests were conducted "to ensure that the subject device performs as intended and meet design specifications," implying they met the internal acceptance criteria, but the specific values or thresholds are not detailed.

Regarding your other points (which are highly relevant for AI/ML devices but not for this traditional device):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable/Not Provided for this device. This device did not undergo clinical or animal studies for substantial equivalence. Bench testing data is typically generated in a lab setting, not from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in the context of expert review for diagnostic AI, is not relevant for this device. Its performance is evaluated through physical and mechanical bench tests, not through expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No expert review or adjudication process is mentioned, as it's not relevant for this type of device's performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was NOT done. This is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. The "ground truth" for this device's performance is derived from physical measurements and engineering specifications in bench testing, not clinical outcomes or expert interpretation of patient data.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established:

• Not Applicable. As there's no training set, there's no ground truth establishment process for it.

In summary: The provided document is a 510(k) premarket notification for a traditional, non-AI medical device (surgical clips and applicators). Therefore, the detailed requirements for AI/ML device performance studies, such as data provenance, expert ground truth, MRMC studies, and training set information, are not present or applicable. The submission relies on non-clinical (bench) testing, sterilization, and biocompatibility data to demonstrate substantial equivalence to a predicate device.

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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.

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