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The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.

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The provided text is an FDA 510(k) clearance letter for an "Endoscopic Injection Needle/Snare." This document does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.

FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on meeting new, specific performance acceptance criteria from a study described in the submission itself. The letter primarily confirms that the device is substantially equivalent for its stated indications for use.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Number of experts and their qualifications for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training set was established.

This information would typically be found in the 510(k) submission itself (which this document is a letter in response to), or in a separate clinical study report, but it is not present in the provided FDA clearance letter. The letter only broadly states the "Indications for Use" for which the device was cleared as substantially equivalent.

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