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The OutBound DIP is indicated for intravenous, intra-arterial, subcutaneous, and The OutBound DIP is indicated for inturvenede, may will with the world in the successions of the controlled infusion rates. The OutBound pump is also intended to provide continuous infusion of a local The Outbound pump is also intracperative site for postoperative pain management.

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I am sorry, but the provided text from the FDA 510(k) letter for the "Outbound Disposable Syringe Infuser" does not contain the specific information you are requesting about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) letter primarily addresses the substantial equivalence determination for regulatory clearance to market the device. It focuses on:

• Device Identification: K982256, Outbound Disposable Syringe Infuser/Outbound II Disposable Infusion Pump.
• General Controls: Acknowledging compliance with general controls like annual registration, good manufacturing practice, labeling, etc.
• Indications for Use: Stating that the device is "indicated for intravenous, intra-arterial, subcutaneous, and epidural infusions at controlled infusion rates" and "for continuous infusion of a local anesthetic at an intraoperative site for postoperative pain management."

The letter does not include details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of detailed information would typically be found in the 510(k) submission document itself, which is a much larger and more comprehensive document than the clearance letter. The clearance letter confirms that the FDA reviewed those documents and made a determination, but it does not reproduce the detailed study results or acceptance criteria within its content.

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