(105 days)
Infant radiant Warmers provide infrared heat in a controlled manner to infants who are unable to maintain thermoregulation based on their own physiology. Infant radiant Warmers may be used to facilitate the newborn's transition to the external environment or to rrovide a controlled open microenvironment.
The Lullaby™ Warmer is a radiant warmer which provides a micro-environment for a premature, new born baby which otherwise might have very little chance of survival as it will not be able to maintain, by itself, its core body temperature. The Lullaby™ Warmer provides a means for the care giver to monitor the baby continuously by giving timely feedback via the different alarm systems and servo controlled thermal feedback mechanism while maintaining a pre-set temperature and thus ensures that the neonate slowly develops the internal organs to enable it to maintain its body temperature.
The Lullaby™ Warmer is an infant radiant warmer. The provided documents detail its premarket notification (510(k)) summary, indicating that it did not require clinical studies for substantial equivalence. Therefore, the device does not rely on a study demonstrating how it meets acceptance criteria based on human expert performance or clinical outcomes. Instead, its acceptance is based on non-clinical tests and compliance with recognized standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Performance, functionality, usability, safety, and reliability characteristics | The Lullaby™ Warmer meets all design requirements and performance claims based on verification and testing activities. |
| Compliance with voluntary standards | The Lullaby™ Warmer complies with voluntary standards as detailed in Sections 09, 15, 16, 17, and 18 of the premarket submission. |
| Meets design requirements | Results of Design verification testing protocols demonstrate that the Lullaby™ Warmer meets all design requirements. |
| Meets performance claims | Results of Design verification testing protocols demonstrate that the Lullaby™ Warmer meets all performance claims. |
| Electrical safety | Addressed through specific design verification protocols. |
| Mechanical safety | Addressed through specific design verification protocols. |
| Reliability | Addressed through specific design verification protocols. |
| System design verification | Addressed through specific design verification protocols. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "The subject of this premarket submission, Lullaby™ Warmer, did not require clinical studies to support substantial equivalence."
Therefore, there was no "test set" in the context of clinical data, no sample size of patients, and no data provenance from human subjects for this device's 510(k) submission. Acceptance was based on engineering and performance verification testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical studies were required, there was no test set involving human subjects where expert ground truth was established for the device's performance with patients. Ground truth in this context would relate to engineering specifications and performance benchmarks, which are established by design and testing engineers.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication.
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. The Lullaby™ Warmer is an infant radiant warmer, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Lullaby™ Warmer is a physical medical device, not an algorithm. Its performance is demonstrated through its functional capabilities, safety features, and compliance with manufacturing and performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the Lullaby™ Warmer's acceptance is based on engineering specifications, technical performance benchmarks, and compliance with recognized voluntary standards. This includes verification that the device maintains a pre-set temperature, provides timely feedback via alarm systems, and operates within specified electrical, mechanical, and safety parameters.
8. The sample size for the training set
Not applicable. There was no "training set" in the context of machine learning or clinical data. The device's design and manufacturing process would involve internal testing and validation against specifications.
9. How the ground truth for the training set was established
Not applicable. As no training set (in the machine learning sense) was used, no ground truth needed to be established for it. The "ground truth" for the device's functionality is its adherence to its design specifications and the regulatory requirements for infant radiant warmers.
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.