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The J-Tip Needleless Injector system is used for the subcutaneous administration of medications which are appropriate to deliver by jet injection.

J-Tip Needles Injector

Apologies, but the provided text from the FDA 510(k) letter for the "J-Tip Needleless Injector" does not contain the information requested regarding acceptance criteria and details of a study proving device performance.

The document is a substantial equivalence determination letter, which means the FDA has determined that the J-Tip Needleless Injector is as safe and effective as a legally marketed predicate device. This letter typically does not include the detailed study methodology, acceptance criteria, or performance data that would be found in a 510(k) summary or the actual submission itself.

Therefore, I cannot provide the specific details you've asked for based on the input document, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set details.
9. Ground truth establishment for the training set.

The letter focuses on the regulatory decision and the device's classification, not the technical study details.

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Injector used for the subcutaneous administrations of xylocaine or calcimar/calcitonin which are appropriate for subcutaneous injection using jet injection or needleless injection systems. For subcutaneous injections only. The device serves as an alternative to the subcutaneous delivery of xylocaine or calcimar/calcitonin medications with needle and syringe.

J-Tip Needleless Injection System

This document is a 510(k) premarket notification decision letter from the FDA regarding the "J-Tip Needleless Injection System". It primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving device performance in the manner requested.

Therefore, I cannot provide the detailed information about acceptance criteria and a performance study based on this document. The document confirms that the device is "substantially equivalent" to previously marketed devices, which is a regulatory determination, not a clinical performance validation against specific acceptance criteria.

Ask a specific question about this device