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This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the nasal lumens and airway anatomy (including nasopharynx and trachea).

This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the airways and tracheobronchial tree.

The subject device is single-use grasping forceps sterilized by Ethylene Oxide.

The subject device consists of the Handle and the Insertion portion. The Insertion portion consists of the Distal end and the Sheath portion. The Handle consists of the Body and the Slider.

The subject device, after inserted into an endoscope from the Distal end, is used to grasp a foreign body or resected tissue with a pair of forceps (the Grasping jaws) at the Distal end by operating the Handle. The foreign body or the resected tissue is retrieved by removing the subject device together with the endoscope from the patient.

This document is a 510(k) summary for Single Use Grasping Forceps. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, the document does not contain information about a study that proves the device meets acceptance criteria in the way requested in the prompt.

The "Performance Data" section (page 9 and page 10) outlines several types of tests conducted:

• Sterilization/Shelf life testing: Conducted according to FDA guidance and ASTM F1980-16.
• Biocompatibility testing: Conducted according to ISO 10993-1, including cytotoxicity, intracutaneous, sensitization, and acute systemic toxicity studies.
• Performance testing - Bench: Included tests for insertability, grasping jaw operation, grasping performance, withdrawal property, device reliability, burr/edge, strength of junction, and breakage tolerance.
• Risk management: Performed according to ISO 14971:2007.

The document states that "design verification tests and their acceptance criteria were identified and performed as a result of this risk management" and that "Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness compared to the predicate devices."

However, none of the requested specific details for a study are provided within this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document summarizes categories of tests but doesn't list specific acceptance criteria or quantitative performance results.
2. Sample size used for the test set and the data provenance: Not provided for any of the tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-read studies or ground truth establishment are specified. The tests are bench and lab-based.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device (forceps), not an AI/imaging algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/algorithm device.
7. The type of ground truth used: For the bench and lab tests, the "ground truth" would be the engineering specifications and established biological safety limits.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm device that uses a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document indicates that various non-clinical bench and laboratory tests were performed to demonstrate substantial equivalence to predicate devices and ensure safety and effectiveness according to established standards. However, it does not provide the detailed study information (e.g., sample sizes, specific acceptance criteria values, performance metrics) that would be expected for an AI/algorithm performance study.

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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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