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Varices Injection Needles are used for endoscopic injection of legally marked sclerotherapy agent and dyes into esophageal or colonic varices

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I am sorry to inform you that the provided document, a 510(k) clearance letter from the FDA for a "Varices Injection Needle," does not contain the information required to answer your request.

The letter only states that the device has been deemed substantially equivalent to a legally marketed predicate device for its stated indications for use. It does not include:

• Acceptance criteria or reported device performance metrics. This letter is about regulatory clearance, not performance specifications from a study.
• Details about any specific studies, such as sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.

Therefore, I cannot populate the table or provide the requested study details based on the input document.

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