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Nature's Cradle® C2000 Series, when used as directed, is an infant motion and sound system designed to closely simulate the mother's heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. This provides a transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. Nature's Cradle C2000 Series can be used with Infant Advantage approved bassinets and hospital nursery tubs or bassinets. Nature's Cradle® C2000 Series is indicated for healthy, full term infants at home or hospital.

Nature's Cradle® C2000 Series is an infant motion and sound system. It uses a mechanism connected to a control module and a low voltage wall-mount transformer. A mattress is placed on top of a moving platform. A fitted sheet is placed over the top of the bassinet or tub and secured with a cord. The device includes safety checks to stop the mechanism if there is excessive weight or obtrusion. All components are non-sterile and reusable.

The provided text is a 510(k) summary for the Nature's Cradle® C2000 Series. It describes the device and its intended use, focusing on its substantial equivalence to predicate devices (Nature's Cradle® Model C1500 and Model M-1). The summary does not present specific acceptance criteria in a quantitative format, nor does it detail a standalone study for the C2000 series with performance metrics. Instead, it relies on the safety and effectiveness demonstrated for its predicate devices.

Therefore, the following information cannot be fully extracted or is not applicable in the typical sense of AI/machine learning device performance studies.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Implicitly, the "test set" for the C2000 Series is its comparison to predicate devices, rather than a standalone performance study. The clinical study for the predicate device, Nature's Cradle® Model C1500, involved 90 full-term infants.
• Data Provenance:
  • Country of Origin: USA (Kaiser Medical Center, Santa Clara, CA).
  • Retrospective or Prospective: The clinical trial mentioned for the C1500 predicate was described as "a clinical trial, published in the Journal of Perinatology Vol. 15, No. 3, 1995," which implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept is not directly applicable to this type of device and study. The "ground truth" here is based on observed infant behaviors assessed using the Brazelton Neonatal Behavior Assessment Scale, which is a standardized clinical assessment tool. The assessment would have been performed by trained clinical staff or researchers, but the number and specific qualifications of those individuals are not detailed in the summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The study involved a clinical assessment using a standardized scale, not an adjudication process among experts evaluating discrete findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/machine learning diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical infant motion and sound system, not an algorithm. The C2000 Series itself did not undergo a standalone clinical trial for demonstrating effectiveness, but rather relied on the substantial equivalence and prior data from its predicate devices. The text states: "The new Nature's Cradle® C2000 Series has not been modified significantly and has the same fundamentals of principles as predicate device, Nature's Cradle Model C1500, Premarket Notification # K960747, except for a smaller size platform. This change does not require additional testing..."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the effectiveness claims comes from observed behavioral outcomes data in infants, assessed using a standardized tool (Brazelton Neonatal Behavior Assessment Scale). These outcomes include adaptability, irritability, crying duration, attentiveness, alertness, sleep patterns, and incidence of colic.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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