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The Sterile endoscope biopsy sampling need to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope.

Sterile endoscope biopsy sampling needle, Model: DT-EN-W7 is mainly composed of needle head, PEEK outer tube assembly, and handle. Sizes are available in 18 - 22 gauge needles. The length of the needles range is between 0 and 80 mm. The needle is used by advancing the entire device to the site of soft tissue sampling through endoscopic channel aperture. The needle is advanced with gentle but firm pressure. Once the needle is in position, stab hard into the tissue and connect the external end of needle tube with aspirator in negative pressure. Retreat the needle head into tube, and get the needle out of the endoscope through the channel. The sample can then be expelled from the stylet notch.

The provided text describes a 510(k) premarket notification for a medical device called "Sterile Endoscope Biopsy Sampling Needle". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets explicit acceptance criteria through a standalone study in the way an AI/ML device would be assessed.

Therefore, many of the specific questions about acceptance criteria for an AI/ML device are not directly applicable or answerable from this document. However, I can extract the relevant performance data summaries and the non-clinical testing conducted to establish substantial equivalence, which serves a similar purpose in the context of this device type.

Here’s a breakdown based on the information available:

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

The document defines "Technological characteristics" which act as acceptance criteria for the device, and then reports that performance bench testing was successfully completed for these. However, exact numerical "reported device performance" values against each criterion are not provided in this summary, only that they met the requirements.

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence between the proposed Sterile Endoscope Biopsy Sampling Needle and its predicate device..." This non-clinical testing served to demonstrate that the device met the "Technological characteristics" listed above.

2. Sample size used for the test set and the data provenance: Not specified in the document for the non-clinical bench testing. The document refers to "the proposed Sterile Endoscope Biopsy Sampling Needle" and "its predicate device" but does not detail the number of units tested.
Retrospective or prospective: The bench testing is inherently prospective as it involves testing the manufactured device against specified criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of physical device testing. The "Technological characteristics" are measured objectively.

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 is a physical biopsy needle, not an AI/ML diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the physical characteristics, the ground truth is defined by the technical specifications and standards (e.g., specific force measurements, pH values, material resistance).
For the animal testing, the ground truth would be the samples obtained during the biopsy procedure. The document states: "Animal testing has been conducted by using Sterile Endoscope Biopsy Sampling Needle and Echotip Ultra/Procore Endobronchial High Definition Ultrasound Needle in pigs. And the results demonstrate that the proposed device has the substantial equivalent performance on biopsy sampling with the predicate device."

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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