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CAPTION Applicators are intended for the simultaneous application of two nonhomogeneous fluids to a treatment site.

CAPTION Applicators consists of two medical syringes, a 12cc syringe and a 1cc syringe, held in parallel alignment in a molded syringe holder. The plungers of the syringes are joined together by a molded link that allows simultaneous actuation of the syringes. The liquids may be applied through either a dual spray or dual cannula tip.

The provided text is a 510(k) summary for the CAPTION Applicator, a medical device for simultaneously applying two fluids. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot provide the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only states:

• Device Description: CAPTION Applicators consist of two syringes in a molded holder, with linked plungers for simultaneous actuation.
• Intended Use: For the simultaneous application of two nonhomogeneous fluids to a treatment site.
• Technological Characteristics: Similar to legally marketed devices in indications for use, materials, and technological characteristics.
• Substantial Equivalence Information: Based on similarities in design features, overall indications for use, and material composition to predicate devices (Micromedics Surgical Sealant Dispenser K881020 and Baxter Healthcare Duploject K973510).

This type of submission typically relies on comparing the new device's design, materials, and intended use to existing, legally marketed devices to demonstrate that it is as safe and effective, rather than conducting a de novo performance study with specific acceptance criteria.

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