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Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.

The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided document describes the acceptance criteria and the study that proves the performance of the Single Use Grasping Forceps (K191900).

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "performance test bench" and "Non clinical tests were conducted," indicating laboratory-based testing rather than clinical data from human subjects. As such, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size of human subjects doesn't directly apply here. The tests were performed on the device itself.

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

This information is not applicable. The study involves non-clinical bench testing and compliance with established standards for device performance, sterilization, and biocompatibility. There is no "ground truth" established by human experts in this context.

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

This information is not applicable, as the study is not based on expert adjudication of clinical findings.

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:

This information is not applicable. This is a 510(k) submission for a medical device (grasping forceps), not an AI-powered diagnostic or assistive technology.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" in this context is the fulfillment of established engineering specifications, performance standards (e.g., tensile strength, clamping strength, jaws opening/closing), and regulatory compliance as defined by international standards (ISO, ASTM, EN, USP) and FDA guidance for medical devices.

8. The sample size for the training set:

This information is not applicable. There is no concept of a "training set" as this is not an AI/machine learning model. The devices are manufactured and tested against predefined specifications.

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

This information is not applicable for the same reason as point 8.

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