(87 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative metrics for the C2000 Series. The acceptance indirectly relies on "substantial equivalence" to predicate devices. | The C2000 Series is stated to be "safe and effective when used as described," based on the demonstration of safety and effectiveness of its predicate devices. |
| Key Similarity (Basis for Acceptance) | Performance Claim (via Predicate Device Studies) |
| Same motion and sound as predicate devices. | Infants using Nature's Cradle environment were more adaptive, less irritable, cried ~65% less, more attentive, alert, slept longer, slept through the night sooner, and had a lower incidence of colic compared to control (from C1500 predicate study). |
| Same mechanism as predicate C1500. | Safe operation due to safety checks (e.g., stopping mechanism for excessive weight/obstruction) in the mechanism. |
| Same device classification product code (80FMS). | Safe and effective for healthy, full-term infants. |
| Same technology and fundamentals of principles. | Safe and effective for healthy, full-term infants. |
| Same indications for use (healthy, full-term infants at home or hospital, 0-16 weeks). | Achieves positive behavioral outcomes in infants. |
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.
§ 880.5140 Pediatric medical crib.
(a)
Identification. A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed end rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may be adjustable.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. The special controls for this device are:(1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged;
(2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation, and be free from surface defects that could result in injuries;
(3) The height of the rail and end panel as measured from the top of the rail or panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches (66 centimeters). Any mattress used in this crib must not exceed a thickness of 6 inches;
(4) Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient;
(5) The distance between components of the side rail (
i.e., slats, spindles, and corner posts) shall not be greater than 23/8 inches (6 centimeters) apart at any point;(6) The mattress must fit tightly around all four sides of the crib base, such that entrapment or impingement of occupant is prevented;
(7) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the flammability of mattresses and mattress pads (FF 4-72, amended) and Standard for the flammability (open flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and
(8) Each device must have the following label(s) affixed:
(i) Adequate instructions for users to care for, maintain, and clean the crib; and
(ii) A warning label on at least two sides of the medical crib with the following language in text of at least 9 millimeters in height:
WARNING: Never leave a child unsupervised when the moveable side is open or not secured.