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The Nurture Rest (including models 100-1-C) is indicated for premature infants undergoing oxygen therapy to maintain an airway and for whom treatment may be facilitated by this repositioning and stabilization device. The premature infants are being continuously monitored for oxygen saturation levels and heart rate in the Neonatal Intensive Care Unit (NICU) by medical professionals.

Nurture Rest is an infant sleep positioning device used by medical staff to position and secure premature infants in a prone, supine, or side position to limit mobility within an incubator in the neonatal intensive care unit (NICU). The Nurture Rest is shaped like the female anatomy in order to encourage a "Kangaroo Care" style positioning technique that mimics being held against a female body/chest while also keeping the infant's head, neck, and spine aligned. This device gives nurses a useful tool in their daily role of repositioning and caring for these special premature infants. The infants for whom the device is used are undergoing oxygen therapy to maintain an airway (intubation, nasal CPAP, bubble CPAP, high flow nasal cannula, or nasal cannula) and are continuously monitored for oxygen saturation levels and heart rate. The Nurture Rest consists of a washable, flame-retardant cloth material.

There are two models of the device (Models 100-1-O and 100-2-C). Both devices are appropriate for prone, supine and side positioning of premature infants. One model of the device (Model 100-1-O) has customizable opening at the head to allow for prone face-down positioning of micro-preemies for whom positioning with the head turned to the side would increase the chance of hemorrhaging due to increased intracranial pressure. The other model (Model 100-2-C) does not have an opening and is for prone with head turned positioning. The device comes with pillows to help stabilize the infant and swaddling straps to minimize motion of the arms and body of the infant. As with standard NICU practices, the Nurture Rest enables the infant to be re-positioned and treated as needed (typically every 4 to 6 hours), which allows NICU staff to cluster care in order to let the infants rest and grow in between physical and emotional stimulation.

The Nurture Rest device is a pediatric position holder for premature infants in the Neonatal Intensive Care Unit (NICU). Below is a summary of its acceptance criteria and the study that proves the device meets them.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the traditional sense, as the studies primarily involve bench, simulated, and material testing.
  • For the bench top and usability testing, the 'sample' involved the "Nurture Rest" device itself and a "doll which was representative of actual premature patients." The number of devices or dolls tested is not explicitly stated.
  • For biocompatibility, durability, coefficient friction, bioburden, storage, and packaging/ship testing, the 'sample' refers to units of the Nurture Rest device. The specific number of units tested is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective data from human subjects. The studies are primarily lab-based (bench, simulated, material testing) and do not involve data from patients. The testing was conducted by Neonatal Loving Kare, Inc. or their contracted labs. The country of origin of the data is not specified but implicitly within the US given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not applicable or not provided in the document. The ground truth for the performance tests was established by objective measurements and functional assessments against predetermined criteria, rather than expert consensus on diagnostic interpretations or outcomes. For usability, the study involved "NICU nurses," but the number and their specific qualifications (e.g., years of experience) beyond being NICU nurses are not detailed.

4. Adjudication Method for Test Set

Not applicable. The reported studies are primarily objective performance, usability, and material tests, not clinical evaluations requiring adjudication of subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. The device is a physical pediatric position holder, not an AI or diagnostic imaging device that would typically undergo such a study. The document describes a comparison to a predicate device primarily based on technological characteristics and intended use, not a comparative clinical effectiveness study against human performance.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device, not an algorithm or software. Therefore, a standalone (algorithm only) performance study is not applicable.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria was based on:

• Objective functional performance: Whether the device could physically position and retain a representative doll (simulated use).
• Material properties standards: Adherence to biocompatibility standards (ISO 10993-1) and comparison of properties like coefficient of friction and bioburden to existing NICU standards/products.
• Usability observation: Direct observation and assessment of NICU nurses using the device during simulated scenarios to confirm safe and effective use.
• Durability and integrity standards: Confirmation that the device maintains its form and function over time and through transport.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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