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The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.

The SNOO Smart Sleeper (SNOO) is comprised of the SNOO bassinet and the SNOO Sleep Sack that iointly constitute an infant securement device intended to facilitate a supine position during sleep. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently. The SNOO Sleep Sack is a cotton swaddle with fixed wings made of woven cotton fabric that extend to the right and left of the infant's body. Three sizes of sleep sacks (small 5-12lbs, medium 12-18lbs. and large 18-25lbs) are provided with each bassinet to accommodate the growing baby. Small loops at the end of each SNOO Sleep Sack wing are slid over the safety clips of the SNOO bassinet to securely position the swaddled infant on the back. The SNOO Sleep Sack has corresponding wings that are designed to be physically attached to those clips after the baby is wrapped in the sleep sack - thereby keeping the infant securely positioned on the back during sleep and to prevent rolling. The SNOO bassinet also provides sound and motion. White noise and rocking can be automatically increased in response to a baby's cries. There is a SNOO App which can be used to adjust the levels of motion.

The provided text describes the SNOO Smart Sleeper, an infant supine sleep system, and presents information related to its regulatory acceptance. While it details acceptance criteria and study results for various aspects, it does not explicitly provide a "study that proves the device meets the acceptance criteria" in a singular, consolidated way, nor does it present the information in the structured format requested for AI/device performance. The request focuses on AI/device performance metrics (such as sensitivity, specificity, FROC, AUC), which are not directly applicable to this mechanical infant sleep system.

However, I can extract the acceptance criteria and reported "performance" based on the provided text, aligning them as closely as possible to the spirit of the request by interpreting "device performance" as the results of the specific tests conducted.

Here's the information extracted and formatted to best answer your request, focusing on the available data:

Acceptance Criteria and Device Performance for SNOO Smart Sleeper

1. Table of acceptance criteria and the reported device performance

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