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The subject device is intended for intravenous fluid, blood and blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.

Abbott LifeCare Standard Tubing Pump (Acclaim)

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a detailed study description. The document is a 510(k) clearance letter from the FDA for a device called "Acclaim™ Infusion Pump."

This type of document typically:

• Confirms that the device is substantially equivalent to a legally marketed predicate device.
• States the intended use and regulatory class of the device.
• Outlines general regulatory obligations.
• Does not include the specific results of performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

To answer your questions, I would need access to the actual 510(k) submission or a summary of safety and effectiveness (SSE) document, which would contain the details of the studies performed to demonstrate substantial equivalence.

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