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BREG's Pain Care 2000 is intended to provide patient controlled intermittent infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. BREG's Pain Care 2000 provides a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).

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This document is a 510(k) clearance letter from the FDA for a device called "PAIN CARE 2000." This type of document typically grants market clearance based on substantial equivalence to a predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria.

While the letter confirms the device can be legally marketed, it does not contain the detailed information requested regarding acceptance criteria and performance study specifics. It primarily focuses on the regulatory determination of substantial equivalence.

Therefore, most of the information requested in your prompt (Table of acceptance criteria, sample sizes, ground truth details, MRMC study, standalone performance) is not present in the provided text.

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