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The Medix MediLEDmini Phototherapy Lamp is intended for the treatment of neonatal hyperbilirubinemia. The device can be used with infants in a bassinet, incubator, open bed or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.

Medil EDmini is a LED Phototherapy lamp for neonatal use. It was specially crafted and designed to be used with incubators. Its small form size allows for great versatility without compromising powér, since it is one of the most powerful units in the market. LED technology is so advanced that its cold light avoids overheating in patients since it does not emit IR or UV radiation. Its high power and therapeutic efficacy reduces treatment costs, allowing the patient to be discharged in less time than with conventional phototherapy. lts small size and versatility is very useful in small environments and where space is a priority. The unit has 3 light intensities to choose: high-medium-low in order to answer different treatment needs

The MediLEDmini Phototherapy Lamp is designed for treating neonatal hyperbilirubinemia.

1. Acceptance Criteria and Reported Device Performance:

The document states that the MediLEDmini Phototherapy Lamp has been tested and meets the requirements of the following standards:

Specifically for the phototherapy capabilities, the document provides the following performance data:

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

The document does not provide information regarding the specific sample size used for any clinical test set or the provenance of any data (e.g., country of origin, retrospective/prospective). The testing described appears to be related to engineering compliance with standards, not clinical performance studies involving a patient cohort.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

This information is not provided in the document. The document describes engineering testing against established standards, not a clinical study requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the document does not describe a clinical study requiring adjudication of a test set. The reported testing is against established engineering safety and performance standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not done according to the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This information is not applicable. The MediLEDmini Phototherapy Lamp is a physical medical device, not an algorithm or AI system for diagnostic or assistive purposes.

7. Type of Ground Truth Used:

The "ground truth" for the reported testing is the requirements and specifications outlined in the referenced international electrical and medical device standards (IEC 60601-1-2, IEC 60601-1, and likely IEC 60601-2-50). These standards define the acceptable safety and performance characteristics for such devices.

8. Sample Size for the Training Set:

This information is not applicable. The MediLEDmini Phototherapy Lamp is a hardware device, not an AI or machine learning model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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