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Single use disposable aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body

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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Light Saber™ Aspiration Needle." It primarily states that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

The letter does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for any test set or data provenance.
• The number or qualifications of experts used to establish ground truth.
• Any adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Whether standalone (algorithm only) performance was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given input.

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