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for injecting contrast media and saline, for angiography

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I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for "Disposable Angiographic Syringes for Nemoto Injectors," which primarily addresses regulatory approval based on substantial equivalence to predicate devices, not performance studies with detailed acceptance criteria.

Therefore, I cannot extract the requested information, which includes:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance for the test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size and ground truth establishment for the training set

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