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The Invictus Medical, Inc. GelShield is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

Invictus Medical, Inc. (Invictus) has developed the Invictus Medical, Inc. GELShield to reduce pressure localization on the heads of infants in Neonatal Intensive Care Units (NICU). The Invictus device is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated. The product achieves this through two design characteristics: first to reduce overall friction between the outer laver of skin covering the skull and external surface; and second, to evenly redistribute external pressures over boney prominences of the skull.

The device wraps around the back of the head starting just behind the ears. It has a three dimensional curvature from foam panels that creates a curved surface of the primary outer material, Recovery5™ HF Healthcare Fabric, a low-friction material that is also used on surgical mattresses. Coupled with silicone appliques on the inner surface, the design helps the device stay in place on the head allowing the infant to move normally. This is augmented through the use of Velcro™ (as part of the device) which is used to snugly secure the device to the head. The Velcro allows the nursing staff to easily remove and re-secure the device as part of the usual care of the patient. The device also contains panels of hydrogel encased in Versaflex designed to reduce pressure localization. The Invictus Medical GELShield is not sterile when used. The device is single patient use, but can be worn by a given patient for multiple use periods during the patient's stay in NICU.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

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