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The Nature's Cradle® Model C1500, when used as directed, is designed to provide a safe and effective transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. The mattress is equipped with motion and sound designed to simulate the mother's heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. Nature's Cradle Model C1500 is intended to be used for healthy, full term infants at home from 0-16 weeks.

The Nature's Cradle® Model C1500 is a new device that is based on the same technology and the same indications for use as Nature's Cradle " Infant Bassinet, Model M-1, 510(k) Premarket Notification # K901763. The moving platform is now embedded in the mattress, thus omitting the bassinett. The new mattress fits standard crib size (27 1/2 wide, 51 7/8" long, 4 1/2" high.) The sounds are fed to the mattress through a speaker cable from a control box located outside the mattress. The motions are generated by a low voltage DC (direct current) motor located underneath the platform and connected to a worm drive gear reduction located in the control module. Control module and moving platform are connected with a tube including speaker wire and power supply for the DC motor.

Here's a breakdown of the acceptance criteria and study information for the Nature's Cradle® Model C1500, based on the provided text, using the template you supplied.

It's important to note that the provided text describes a medical device, not an AI/ML algorithm. Therefore, many of the requested fields (like those pertaining to AI performance metrics, ground truth establishment for training sets, MRMC studies, etc.) are not applicable or cannot be extracted from this type of documentation. The information provided focuses on demonstrating substantial equivalence to a predicate device and general safety/effectiveness, rather than specific AI-related performance metrics.

Acceptance Criteria and Study for Nature's Cradle® Model C1500

Study Information (Based on provided text, specific to the clinical trial mentioned for the predicate device, or general claims for the new device where applicable):

1. Sample size used for the test set and the data provenance:

   • Test Set (Clinical Trial): 90 full-term infants.
   • Data Provenance: Prospective clinical trial conducted at Kaiser Medical Center, Santa Clara, CA, USA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. The ground truth for the clinical trial was established through direct observation and assessment of infant behaviors using the Brazelton Neonatal Behavior Assessment Scale, not through expert consensus on a test set in the context of an AI/ML device.

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

   • Not specified. The clinical trial mentions evaluation using the Brazelton Scale, but no specific adjudication method for discrepancies among observers is detailed in the provided text.

4. 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:

   • No. This is a medical device, not an AI/ML algorithm. An MRMC study is not relevant here.

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

   • No. This is a medical device, not an AI/ML algorithm. Standalone algorithm performance is not relevant here. The device itself is the "standalone" component being evaluated.

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

   • Behavioral Outcomes Data / Clinical Observations. The ground truth was based on the observed behaviors and developmental milestones of infants as measured by the Brazelton Neonatal Behavior Assessment Scale.

7. The sample size for the training set:

   • Not Applicable. This is a medical device approval based on a clinical trial and substantial equivalence, not an AI/ML model with a separate training set.

8. How the ground truth for the training set was established:

   • Not Applicable. As no training set for an AI/ML model is mentioned, this question is not relevant.

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