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The device is used for endoscopic injection into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.

The Sclerotherapy Needle device consists of Luer connector, handle, sheath, infusion tube, fixed button connection tube and needle. EO sterilization and use for single use only. The Sclerotherapy Needle device is designed to pass through the channel of endoscope to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1200mm,1800mm, 2000mm, 2300mm, and the minimum working channel is ф 2.8 mm.

This document describes the premarket notification (510(k)) for the Sclerotherapy Needle by Zhejiang Chuangxiang Medical Technology Co., LTD., which has been determined substantially equivalent to the predicate device. However, this document does not contain the specific acceptance criteria or a detailed study outlining device performance against such criteria for the Sclerotherapy Needle.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (Hangzhou AGS's Disposable Sclerotherapy Needle, K190032) based on similarities in design, configuration, intended use, and fundamental technology.

Here's an analysis of the information provided and what is missing in relation to your request:

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

• Missing. The document explicitly states: "The following bench tests were performed on Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing." However, it does not provide a table detailing specific acceptance criteria (e.g., maximum force for needle deployment, flow rate through the infusion tube, specific dimensions, etc.) or the measured performance values for these tests. It only states that the tests "were passing," which indicates compliance with internal or regulatory requirements but lacks the specific data requested.

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

• Missing. The document mentions "bench tests," but it does not specify the sample size for these tests or the provenance of the data.

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 / Missing. This device is a physical medical instrument (sclerotherapy needle), not an AI/imaging device requiring expert interpretation for ground truth establishment. The "bench tests" would typically be evaluated against engineering specifications, not expert consensus on diagnostic images.

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

• Not Applicable / Missing. As above, this concept typically applies to diagnostic studies with multiple readers, not bench testing of a physical medical device.

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 medical device, not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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):

• Not Applicable. For the bench tests performed ("Appearance, Physical properties"), the "ground truth" would be the device's adherence to engineering drawings, material specifications, and functional requirements, as validated by standard measurement techniques and test methods. It's not a diagnostic "ground truth" in the clinical sense.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As above, no training set.

Summary based on the provided text:

The document confirms that the Sclerotherapy Needle underwent "bench tests" for "Appearance, Physical properties" and that the results "were passing." It also notes compliance with biocompatibility (ISO 10993), sterilization (ISO 11135), and ethylene oxide residuals standards (ISO 10993-7). However, the detailed acceptance criteria (what constitutes "passing" for each specific test of appearance and physical properties) and the actual performance data are not disclosed in this summary. The entire premise of this 510(k) summary is to demonstrate substantial equivalence to an existing predicate device rather than to provide a comprehensive performance study with explicit acceptance criteria and results.

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