(122 days)
INDICATIONS FOR USE: The MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.
The Medix MediLED is neonatal phototherapy equipment with blue and white LEDs, incorporating height and angle adjustments. The device is labeled and indicated for: treatment for neonatal hyperbilirubinemia. The device is intended for use in healthcare professionals in a clinical setting.
Fitted with a rolling base with brakes, column, and mobile head containing the equipment's electronics. The design allows the equipment to be used with incubators, infant warmers or cradles of all type and brand.
Features:
- Microprocessor mobile phototherapy equipment. (mobile stand with brakes) .
- Ideal for use in incubators, cribs and infant warmers .
- High brightness LED technology: led quantity 492 Blues ,108 whites. .
- Total Hour meter (LED useful life) and partial time (treatment). .
- Technical Service Indicator. .
- Examination light. .
- It is possible to maneuver with all LEDs on. .
- Continuous height shift by means of an actuator .
- Headlight positioning without the use of a tool .
Commands are found on the front of the equipment's head, consisting of three keys, two of which allow to operate separately blue from white LEDs, making it possible to check the patient's real skin color or perform interventions under white light. By turning on the blue LEDs, total and treatment counters are enabled. These indicate the total and treatment time of the phototherapy unit. The third key (reset) is used to restore the treatment counter. It also has two indicators; a green one showing the equipment is connected to the power supply and ready to be used, and a yellow one indicating the need of technical service assistance.
Blue LEDs do not emit significant ultraviolet (UV) neither infrared (IR) energy, resulting in no risk of UV, IR exposure nor excessive warming up for the patient.
The provided text describes the MediLED Phototherapy Lamp and its substantial equivalence to a predicate device, as opposed to presenting a study proving a device meets specific acceptance criteria based on its performance metrics. The information focuses on regulatory approval rather than a clinical or performance study with detailed acceptance criteria and results.
Therefore, many of the requested fields related to a specific study and performance metrics cannot be filled from the given text.
However, I can extract the information available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics for the MediLED Phototherapy Lamp in the context of a dedicated performance study. Instead, it states that the device "meets the requirements of the following Standards" and lists IEC 60601-1-2, IEC 60601-1, and EN 60606-1-2-50. These are likely safety and essential performance standards, not necessarily clinical effectiveness criteria in terms of hyperbilirubinemia treatment outcomes for a specific study.
The document provides the following "Treatment Light" and "Examination light" specifications:
Treatment Light Performance:
| Distance [cm] | White + Blue [uW/cm2/nm] | Blue [uW/cm2/nm] | White [uW/cm2/nm] | Effective Surface Length x Width [cm] |
|---|---|---|---|---|
| 30cm | 49 | 44 | 5 | 37x19 |
| 40cm | 40 | 36 | 4 | 40x21 |
| 50cm | 33 | 30 | 3 | 46x24 |
Note: The document does not specify "acceptance criteria" for these performance characteristics, but rather reports the device's measured performance.
Examination Light Performance:
| Distance [cm] | Illuminance [Lux] | Light area Length x Width [cm] |
|---|---|---|
| 30 | 3600 | 32x21 |
| 40 | 2600 | |
| 50 | 2000 |
Note: Similar to the treatment light, "acceptance criteria" for these values are not provided, only the reported performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The provided text describes a 510(k) submission focused on substantial equivalence to a predicate device, specifically regarding design, materials, and compliance with general safety standards. It does not detail a clinical or performance study involving a patient-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a study that used experts to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of an adjudication process for a test set.
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. This document pertains to a medical device approval for a phototherapy lamp, not an AI-assisted diagnostic tool or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The information details the physical and functional characteristics of a phototherapy lamp.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a clinical study requiring ground truth for diagnosis or outcome assessment. The "truth" in this context refers to the device meeting engineering and safety standards.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device or a clinical outcome study.
9. How the ground truth for the training set was established
Not applicable. Same as above, there is no training set mentioned.
§ 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).