(134 days)
The Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.
The Airborne Observation and Phototherapy Light is an LED phototherapy (and observation) light. The LED light has both white and blue LED lights that are designed to serve as an observation light or a phototherapy light for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. The phototherapy light can be used for infants in incubators by mounting it on the hood
The provided text describes a 510(k) premarket notification for a medical device called the "Airborne Phototherapy Light". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and studies in the manner typically seen for novel AI/ML-driven devices or those undergoing rigorous clinical efficacy trials.
Therefore, the information required to answer your specific questions about acceptance criteria, test set details, expert ground truth, MRMC studies, standalone performance, training set details, and specific effect sizes is not present in the provided document.
This document is a marketing clearance notification for a phototherapy light for neonatal hyperbilirubinemia. The "performance testing" mentioned refers to compliance with electrical and medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50), which are general safety and performance requirements for a device of this type, not specific outcome-based acceptance criteria or a study proving its efficacy for treatment in a clinical sense.
The core argument for clearance is substantial equivalence based on:
- Similar indications for use (treatment of neonatal hyperbilirubinemia).
- Similar environment for use (hospital/institution).
- Similar patient population (neonatal).
- Similar technology (blue light-emitting diodes - LEDs).
- Compliance with relevant safety standards.
The discussion about irradiance levels (5 µW/cm²/nm resulting in a 15% decrease of serum bilirubin) refers to published guidelines from the American Academy of Pediatrics, not to a performance study conducted on the Airborne Phototherapy Light itself. The device's irradiance is stated to be within the therapeutic range suggested by these guidelines, even if slightly less than the predicates.
In summary, this document does not contain the information needed to fill out your request because it's a regulatory submission for a device demonstrating substantial equivalence to existing, well-understood technology, not a novel device requiring extensive performance studies as you've outlined.
To answer your request, if this were a document about a software with AI/ML components for diagnosis or treatment, it would typically include a dedicated section on clinical performance testing, often with a detailed statistical analysis plan, acceptance criteria, and specific study results. This document does not describe such a study.
§ 880.5700 Neonatal phototherapy unit.
(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).