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The QS Delivery System is intended for the delivery of hemostatic agents that can be mechanically mixed and delivered to bleeding sites.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "QS Delivery System." This document is a regulatory approval letter and an "Indications for Use Statement." It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the given text. The document confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed, but does not detail the scientific studies or performance data that would typically be included in a technical report or submission summary.

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The SUB-Q, Inc. Irrigation Syringe Kit is intended to be used in body cavities and wound sites to irrigate or deliver general wound management materials, such as saline, and other FDA cleared solutions.

Irrigation Syringe Kit

This document is a 510(k) clearance letter for an "Irrigation Syringe Kit" and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

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