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The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.

The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.

The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.

The Syndeo PCA Syringe Pump consists of a syringe infusion pump with locking cover, and a PCA button for delivery of bolus doses of medication upon request. The pump accommodates 60 mL plastic syringes or 50 mL prefilled syringes. The pump can communicate with wireless accessories such as commercially available infrared printers or computing tools with device communications that are compatible with the Palm Operating System.

The Syndeo pump is capable of continuous, intermittent, or continuous plus intermittent infusion of small volumes of medications, following standard patientrequest PCA regimens. The pump operates on 4 D-size alkaline batteries or the optional AC rechargeable pack. The pump uses microprocessor electronics for control of all functions. A large, color touch-screen display provides a userfriendly graphic user interface (GUI), and simple programming steps that lead the operator through programming. As an added safety feature, the pump employs a variety of sensors to ensure appropriate syringe loading and door closure prior to allowing initiation of infusion.

This document is a 510(k) summary for the Syndeo PCA Syringe Pump. It is a premarket notification for a medical device and therefore does not contain details of any clinical study or acceptance criteria related to software or AI performance.

The provided text describes the device, its intended use, and states that it is substantially equivalent to predicate devices. It mentions that the pump uses "microprocessor electronics for control of all functions" and a "large, color touch-screen display" but does not describe any AI or algorithmic components that would require performance criteria or studies as typically understood for AI/ML devices.

Therefore, I cannot provide the requested information about acceptance criteria or studies proving the device meets them, as those details are not present in the provided 510(k) summary. The nature of a 510(k) submission generally focuses on substantial equivalence to a legally marketed predicate device rather than detailed performance studies for novel AI components.

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