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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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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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