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The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.

The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

• Endoscopic marking of lesions
• Hemostasis for:
  • Mucosal/Submucosal defects
  • Bleeding Ulcers
  • Arteries

The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy for tissue approximation with opening sizes of 6 to 24mm on a flexible delivery system.

The Padlock ClipTM defect closure device is mounted and secured at the distal tip on the outside surface of a flexible endoscope. The Padlock ClipTM is deployed using an independent hand control. The linking cable to the hand control is not located within the endoscopic accessory channel. The Padlock ClipTM delivery system includes a central "tissue chamber" that resides on the distal tip of the endoscope. Clinically efficacious tissue manipulation techniques may be used to pull target tissue into this "tissue chamber" to approximate a larger volume of tissue than would otherwise be approximated by deploying the clip alone. The Padlock ClipTM delivery system is compatible with flexible endoscopes with distal tip outer diameters ranging from 9.5mm to 14mm.

Below is the requested information regarding the acceptance criteria and the study proving the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided text does not specify the sample sizes used for the test set or the provenance (e.g., country of origin, retrospective/prospective) of the data. The tests listed are primarily non-clinical performance and biocompatibility tests.

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

The provided text does not mention the use of experts to establish ground truth for a test set. The evaluation focuses on non-clinical performance and biocompatibility.

4. Adjudication method for the test set:

The provided text does not specify an adjudication method. The tests conducted are objective measurements against defined standards.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This document describes the modification of a medical device (Padlock Clip™) and its non-clinical performance and biocompatibility, not an AI-assisted diagnostic tool.

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

A standalone performance study as described (algorithm only without human-in-the-loop) was not done. This document is for a mechanical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the tests performed appears to be the established standards and specifications outlined in the ISO standards for biocompatibility tests (ISO 10993-5, 10993-10, 10993-11) and the device's internal specifications for functional and component strength tests.

8. The sample size for the training set:

A training set is relevant for machine learning algorithms. Since this submission is for a modified mechanical medical device, there is no mention of a training set or its sample size.

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

As there is no mention of a training set, the method for establishing its ground truth is not applicable and therefore not provided in the document.

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