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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 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:
  • o Mucosal/Submucosal defects
  • o Bleeding Ulcers
  • o 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 Clip™ defect closure device is mounted and secured at the distal tip on the outside surface of a flexible endoscope. The Padlock Clip™ is deployed using an independent hand control. The linking cable to the hand control is not located within the endoscopic accessory channel. The Padlock Clip™ 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 Clip™ delivery system is compatible with flexible endoscopes with distal tip outer diameters ranging from 9.5mm to 14mm.

The provided document is a 510(k) premarket notification for a medical device called the "Padlock Clip Pro-Select™ defect closure system". The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K180689), specifically due to the addition of an alternate supplier for a component.

Therefore, the study described mainly focuses on non-clinical testing to ensure that the change in supplier does not affect the safety or effectiveness of the device. There are no clinical studies involving human patients or AI algorithms in this document.

As such, I cannot provide information on many of the requested points, such as sample size for test sets (as it's not applicable in the context of clinical data), number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth for training sets.

However, I can extract information related to the acceptance criteria and the performance results from the non-clinical testing performed.

Here's the information that can be extracted:

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

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

This document describes non-clinical laboratory testing, not a clinical study involving a test set of human data. Therefore, "sample size for the test set" as it pertains to patient data is not applicable. The tests are performed on the device itself and its components. The provenance of the data is from the manufacturer's (STERIS Corporation) testing, presumably in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a non-clinical device performance study, not a study relying on expert human interpretation of medical images or data.

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

Not applicable, as there is no human adjudication of medical data involved in this non-clinical study.

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

Not applicable. This submission is for a medical device (a clip system), not an AI algorithm, and does not involve human readers interpreting medical images with or without AI assistance.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device evaluation is based on established scientific and regulatory standards for medical device biocompatibility and functional performance. It relies on:

• ISO 10993 series standards (parts 3, 5, 6, 10, 11): These are international standards for the biological evaluation of medical devices.
• ASTM F2129: An ASTM standard related to corrosion susceptibility.
• FDA guidance documents: Specifically, "Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol Draft Guidance for Industry and Food and Drug Administration Staff, April 19, 2019."
• Predicate device methodology: Using the same test methodology as used for the predicate device (K180689 or K120814).

8. The sample size for the training set

Not applicable. This is not an AI algorithm development or clinical study with a training set.

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

Not applicable.

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