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The neoBLUE® LED Phototherapy System is indicated for the treatment of hyperbilirubinemia for neonates and infants in a hospital environment, and administered by trained, professional medical staff, on the order of a licensed medical practitioner. The light can be used with a bassinet, incubator, open bed, or radiant warmer.

The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand.

The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The light can be used independently of the roll stand, and can be placed directly on an incubator with a flattopped surface.

This document describes the Natus Medical Incorporated neoBLUE® LED Phototherapy System (K160305).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present acceptance criteria in a tabular format with corresponding reported device performance metrics in the way one might see for an AI algorithm's diagnostic accuracy. Instead, the document focuses on compliance with established medical device standards and functional specifications for a phototherapy unit.

However, based on the non-clinical testing section, the implicit acceptance criteria are compliance with relevant safety and performance standards for medical electrical equipment and phototherapy devices.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as the device is a phototherapy system and not a diagnostic AI algorithm that relies on a "test set" of patient data for performance evaluation in the typical sense. The testing performed was for compliance with electrical, safety, and performance standards, and for demonstrating substantial equivalence to a predicate device through engineering and design validation. The provenance in this context would refer to internal validation procedures and results.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable. The device's performance is not evaluated against a "ground truth" derived from expert consensus on patient data. Instead, it is evaluated against established engineering specifications, safety standards, and functional requirements.

4. Adjudication Method

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessment where discrepancies need to be resolved (e.g., in clinical trials or diagnostic accuracy studies involving multiple readers). This document describes the regulatory clearance of a medical device based on compliance with standards and functional testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The neoBLUE® LED Phototherapy System is a treatment device, not a diagnostic AI tool intended to assist human readers in interpreting medical images or data. Therefore, an MRMC study related to reader performance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a standalone phototherapy unit; it is not an algorithm, and its function does not involve human interpretation of its output in the way an AI diagnostic tool would.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Compliance with recognized international and national standards for medical electrical equipment and infant phototherapy.
• Engineering specifications for light intensity, wavelength, and safety.
• Demonstration of substantial equivalence to a legally marketed predicate device (K022196 Natus Blue Light Phototherapy Unit) in terms of intended use, operating principles, and therapeutic output.

8. The Sample Size for the Training Set

This is not applicable. The device is not an AI algorithm that undergoes a "training" phase with a dataset.

9. How the Ground Truth for the Training Set Was Established

This is not applicable.

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The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-shelf AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home.

The BiliBee LED Phototherapy System is both a battery-operated device or AC/DC regulated power that provides therapeutic light through an LED illuminator panel for the treatment of neonatal jaundice (hyperbilirubinemia). Treatment is applied by placing the patient (neonate) on the BiliBee LED Phototherapy System panel with a disposable sheath separating the child from the panel's surface. The patient's eyes do not need to be covered during treatment. Treatment is intended to be applied 24 hours a day until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Treatment time is expected to range from 3 days to 3 weeks. Phototherapy treatment of neonatal jaundice using the BiliBee LED Phototherapy System can be applied at home or in a hospital.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (Bilibee LED Phototherapy System), which primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's description and intended use.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets specific performance criteria.
• Information on sample sizes for test sets or training sets.
• Data provenance, details about experts, adjudication methods, MRMC studies, or standalone performance.
• The type of ground truth used or how it was established.

The document states that the device "does not raise any new safety concerns" because it uses the "same operating principle of delivery of light to degrade bilirubin" as its predicate devices. This implies that the performance aspects related to light output are expected to be similar or equivalent to established standards for phototherapy devices, but no specific performance study results, acceptance criteria, or statistical analyses are presented in this summary.

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