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Nasal and sinus packings are used to absorb excess body fluids after septal, turbinate, or rhinoplastic surgery or endoscopic sinus surgery, and for the control of epistaxis (i.e., nose bleeds). Thev are packaged individually as a sterile, dried and compressed sponge that is inserted into the nasal or sinus cavity. When expanded via absorption of blood after insertion, the nasal packing is intended to fill the necessary space to prevent lateral motion of the turbinate and provide gentle pressure on the mucosa. The sinus packing is intended to selectively pack only the ostiomeatal complex leaving the nasal cavity clear for breathing.

M-PACT nasal and sinus packings are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde. Once the chemical reaction has taken place and the foam sponge has cured, the material is washed clean of any residual chemicals.

M-PACT's nasal and sinus products will be sold in different configurations with drawstrings and with and without airway tubes. The products will be provided sterile via gamma radiation in industry standard Tyvek/film and metalized polyester peelable pouches.

This document is a premarket notification (510(k)) and does not contain the detailed information needed to answer your questions about acceptance criteria and a study proving device performance. The summary statement outlines the device, its intended use, and claims substantial equivalence to existing devices.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance: The document states, "The device is currently in the validation process and will not be marketed until the validation is complete." This indicates that the performance criteria and the results of a study demonstrating compliance with those criteria are not yet available or are not included in this summary statement.
• Study Details (Sample Size, Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone, Training Set): Since the validation study is still in progress or not yet detailed, none of these specifics related to a performance study can be found.

In summary, the provided text describes the device and its intended use but does not present the results of a performance study against acceptance criteria.

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