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The DUPLOJECT EASY-PREP System is indicated for the preparation and application of TISSEEL VH Fibrin Sealant.

The DUPLOJECT EASY-PREP System is a collection of standard components used for the reconstitution and application of TISSEEL VH Fibrin Sealant. The system consists of the following components: two double-ended Fluid Transfer Spikes, a QUIK-FILL Syringe Filler and a pre-assembled DUPLOJECT Double-Barreled Syringe Applicator.

This document is a 510(k) premarket notification for the DUPLOJECT EASY-PREP Fibrin Sealant Preparation and Application System. It is a submission for a medical device that facilitates the reconstitution and application of TISSEEL VH Fibrin Sealant. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria. This is common for 510(k) submissions, especially for devices classified as Class II, where substantial equivalence to predicate devices is the primary mechanism for market clearance, rather than extensive clinical efficacy studies with predefined acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table detailing acceptance criteria and reported device performance, or details about sample sizes, ground truth establishment, or multi-reader studies, as these data points are not present in the provided document.

The document primarily focuses on:

• Device identification and submitter information.
• Classification and predicate devices.
• A brief description of the device and its intended use.
• The FDA's determination of substantial equivalence and market clearance.

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