(89 days)
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
| Criterion Description | Acceptance Criteria (Target) | Reported Device Performance (Nature's Cradle® Model C1500) |
|---|---|---|
| Safety and Effectiveness (Overall) | As safe and effective as predicate device (Nature's Cradle® Infant Bassinet, Model M-1, K901763) | "Reliability testing shows this product to be as safe and effective as predicate device..." "The new device has proven safe and effective when used as directed." |
| Infant Adaption | Improved adaptation compared to control. | Infants "were more adaptive." |
| Irritability Reduction | Less irritable compared to control. | Infants "less irritable." |
| Crying Reduction | Significant reduction in crying compared to control. | Infants "cried approximately 65% less." |
| Attentiveness | More attentive compared to control. | Infants "were more attentive." |
| Alertness | More alert compared to control. | Infants "and alert." |
| Sleep Duration | Longer sleep periods compared to control. | Infants "slept for longer periods." |
| Sleeping Through the Night | Sooner achievement of sleeping through the night compared to control. | Infants "and slept through the night sooner." |
| Colic Incidence | Lower incidence of colic compared to control. | Infants "plus experienced a lower incidence of colic." |
| Device Classification | Same as predicate device (80FMS). | "The Nature's Cradle® Model C1500 has the same device classification product code (80FMS)." |
| Technology/Principles | Same as predicate device. | "...the same technology and fundamentals of principles..." |
| Indications for Use | Same as predicate device (healthy, full-term infants, 0-16 weeks, home use). | "...the same indications for use as the legally marketed, predicate device." |
| Software for Motion/Sound | Same as predicate device. | "The Nature's Cradle® Model C1500 uses the same software for motion and sound as predicate device, Model M-1." |
| Control Panel Functions | Same as predicate device. | "...and uses the same control panel functions for motion and sound as predicate device, Model M-1." |
| Transformer | Same as predicate device (double-insulated transformer). | "It also uses the same double-insulated transformer as proven safe and effective in predicate device Model M-1." |
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):
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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.