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The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application. The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.

The P7000 is a variable pressure syringe pump suitable for critical care applications.< This instrument functions with a range of standard, single use, disposable. Iuer-lock svringes of various types and accepts syringe sizes of 5, 10, 20, 30, 50, and 100ml. The P7000 is a microprocessor controlled device designed to use standard, single use, disposable extension sets with luer-lock connectors, of type designed for use on the P7000 syringe pump. The pump can be used with either dedicated or nondedicated syringe extension sets. The dedicated sets include a pressure sensing disc which can be used for additional features. Or, non-dedicated sets (standard sets) can be utilized for standard syringe pump needs.

The provided document is a 510(k) Premarket Notification for the ALARIS Medical Systems Model P7000 Variable Pressure Syringe Pump. This document is a regulatory submission for a medical device and does not contain the type of study data and acceptance criteria information typically associated with AI/ML-based diagnostic devices. It primarily focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for device performance as it is not present in this document. The document describes the device, its intended use, and states its technological characteristics are similar to a predicate device (Baxter Corporation Auto Syringe AS40A Infusion Pump, K940147). This equivalence is the basis for its approval, not a separate performance study with specific metrics.

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