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The MedMate™ Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules. The device features a shield that prevents accidental needle sticks.

The MedMate Guarded Needle is compatible for use with standard luer-slip and luer-lock syringes.

Advanced Medical Innovations Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules.

This submission pertains to the MedMate™ Guarded (18g) Needle. The provided document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria. Instead, it is a 510(k) summary and an FDA clearance letter, indicating that the device was found substantially equivalent to a predicate device based on its technological characteristics and function.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states:

• "No non-clinical tests were performed."
• "Clinical testing was not performed."

The clearance was based on substantial equivalence to the BD Eclipse Hypodermic Needle (K010188).

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