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The injection needle is intended for endoscopic injection into the gastrointestinal mucosa.

The Injection Needle mainly consists of a cap, needle, boosting tube, and positioning ring, all made of 304 stainless steel. It also contains an outer tube and nut made of PTFE. The spring and spring tube are made of 302 stainless steel. The shell and injection handle are made of ABS. The bushing is made of TPE (SBS), and the inner tube is made of nylon. The products are intended for single use; an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the product and the mucosa of the human digestive tract of less than 1 hour.

The provided text describes a 510(k) submission for an "Injection Needle" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for the new device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, Number of experts, Adjudication method, MRMC study, Standalone study, Type and establishment of ground truth for test and training sets) cannot be fulfilled from the provided text, as this information is not present. The submission focuses on comparing the characteristics of the new device to a predicate device to claim substantial equivalence, which is a different type of evaluation than a direct performance study against defined acceptance criteria.

However, based on the provided text, here's what can be extracted:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a formal study with quantitative results against pre-defined thresholds. Instead, it presents a comparison of the new device's characteristics against a predicate device to demonstrate substantial equivalence. The "performance" described is in terms of similar technical characteristics and capabilities to the predicate.

2. Sample sized used for the test set and the data provenance

Not applicable. The submission describes a comparison of technical characteristics and an assessment of safety and effectiveness based on biocompatibility, accelerated aging, performance, and sterilization validation testing. There is no "test set" in the context of a clinical performance study with human data or a labeled dataset for AI evaluation. The data provenance simply refers to these internal engineering and biological safety tests.

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

Not applicable. No ground truth for a test set is mentioned.

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

Not applicable. No test set requiring expert adjudication is mentioned.

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 not an AI device or a diagnostic device where MRMC studies would typically be performed.

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

Not applicable. This is a medical device (an injection needle), not an algorithm or AI.

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

Not applicable. Ground truth, in this context, would relate to a clinical diagnostic or AI performance study, which is not what this submission describes. The "truth" considered here is that the device, through various engineering and biological tests, meets safety and performance requirements that are substantially equivalent to a legally marketed predicate.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model.

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

Not applicable. This is a medical device, not an AI model.

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