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Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap, Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.

The provided text is a 510(k) summary for the Disposable Endoscope Injection Needles. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on establishing substantial equivalence to a predicate device based on:

• Device Description: What the device is made of and its configurations.
• Intended Use: How the device is meant to be used.
• Comparison of Technological Characteristics: A table comparing features of the proposed device to a predicate device.
• Non-clinical Performance Data: Mentions conformity to ISO standards for biocompatibility and sterilization, and some bench tests (appearance, physical properties) that "passed."
• Clinical Test Data: Explicitly states, "No Clinical Study is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because these aspects are relevant to AI/ML device evaluations and are not present in this 510(k) for a conventional medical device.

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The Disposable Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa to:
• introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system;
• aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures;
• control non-variceal hemorrhage.

The Disposable Endoscope Injection Needle consists of Sheath, Handle buckle, Handle, Booster tube, Handle end cap, Outer tube, Inner tube, Metal end cap and injection needle tip. It is available in a variety of configurations with varying needle lengths, gauges and working lengths.

The provided text is a 510(k) summary for a medical device called the "Disposable Endoscope Injection Needle." It describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, it explicitly states that "No Clinical Study is included in this submission."

Therefore, I cannot provide information about acceptance criteria and a study that proves the device meets clinical performance acceptance criteria, as no such clinical study was conducted or presented in this document. The submission relies solely on non-clinical (bench) testing and substantial equivalence to a predicate device.

Here's what I can extract regarding acceptance criteria and performance based only on the non-clinical data provided:

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):
The document does not specify the sample sizes used for the non-clinical (bench) tests. The data provenance is implied to be from Yangzhou Fartley Medical Instrument Technology Co., Ltd. in China, where the device is manufactured. These are all prospective bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These were non-clinical, objective bench tests, not clinical evaluations requiring expert interpretation of results or establishment of ground truth in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as these were objective bench tests, not subjective interpretations requiring adjudication.

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 device is a physical medical instrument (an injection needle), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" was defined by engineering specifications, industrial standards (like ISO 10993, ISO 11135), and the physical properties required for safe and effective function of such a device.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

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