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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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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:

Note: The document does not specify "acceptance criteria" for these performance characteristics, but rather reports the device's measured performance.

Examination Light Performance:

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.

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The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be used in two operating modes: Air Control Mode and Skin Control Mode with two probes that can be used with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress-effect on the newborn.

The NATAL CARE ST-MX/LX/BX incubator is a new updated line of intensive care incubators with skin and air microprocessor temperature control. incorporating the latest technical and design advances for neonatal care.

The distinctive features of an intensive care incubator are offered: together with large displays showing skin and air temperature, with their respective control temperatures. A graphic display (electroluminescent or LCD) allows the selection of a conflagration options menu, and checks modular accessories that are optionally incorporated (pulse oximetry, humidity servo control, oxygen servo control, weighing scales).

NATAL CARE ST-MX/LX/BX incubator is comprised of three main elements: the clear hood, shell and stand. Together they measure H 53 in X W 41.3 in X D 23.5 in.

Two skin temperature probes are incorporated, allowing its use with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress- effect on the newborn.

The Medix NATAL CARE ST-MX/LX/BX incubator is a neonatal incubator. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than primary evidence of meeting specific acceptance criteria through a dedicated study.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state a table of quantifiable acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness.

The document states:

• "Testing of the Medix NATAL CARE ST-MX/LX/BX incubator included functional performance and electrical safety testing as outlined in FDA Guidance Documents and regulations."
• "Based upon the testing and comparison to the predicate devices the Medix NATAL CARE ST-MX/LX/BX incubator has the same intended use, with similar technological characteristics. The system performs as intended and does not raise any new safety or effectiveness issues."

This implies that the device "performed as intended" and met the "functional performance and electrical safety" requirements of relevant FDA guidance and regulations, but no specific numerical criteria or results are provided in this summary.

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

The document does not specify a "test set" in the context of a clinical study or evaluation involving patient data. The testing mentioned appears to be engineering/functional performance and electrical safety testing.

• Sample Size: Not applicable/not specified for a clinical test set. The testing was likely performed on units of the device itself.
• Data Provenance: Not applicable, as there's no clinical data explicitly mentioned. The testing was presumably conducted by Medix i.c.s.a.

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

This is not applicable as the document describes functional and electrical safety testing, not a study requiring expert-established ground truth on patient data.

4. Adjudication Method

Not applicable, as there's no mention of a human-centric study requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is typically used for diagnostic or imaging AI devices, not for
neonatal incubators where the primary assessment is functional and safety performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical medical device (an incubator), not an algorithm or software-only device.

7. Type of Ground Truth Used

The "ground truth" for the functional and electrical safety testing would be the pre-defined engineering specifications, regulatory standards (e.g., electrical safety standards), and performance requirements for neonatal incubators. There's no mention of clinical patient data, pathology, or outcomes data being used as ground truth for this type of device's 510(k) submission.

8. Sample Size for the Training Set

Not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

In summary, the provided 510(k) document indicates that the Medix NATAL CARE ST-MX/LX/BX incubator underwent functional performance and electrical safety testing to demonstrate its performance and safety, satisfying regulatory requirements by establishing substantial equivalence to predicate devices. However, it does not contain the details of acceptance criteria or study methodologies typically associated with clinical performance studies or AI/ML device evaluations as requested in your prompt.

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