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The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBlue blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.

Device Description

The neoBLUE blanket LED Phototherapy System is a portable phototherapy system that consists of five components: the neoBLUE blanket phototherapy light box, fiber optic blanket with attached cable, blanket mattress, disposable mattress covers, and power supply. The neoBLUE blanket LED Phototherapy System delivers a narrow band of high-intensity blue light via a blue light emitting diode (LED), in order to provide treatment for neonatal hyperbilirubinemia.

The portable neoBLUE blanket light box contains a blue LED which emits light in the range of 400 – 550 nm (peak wavelength 450-475 nm). This blue light is directed through an optical fiber cable to the fiber optic blanket pad. The fiber optic blanket pad is composed of high performance optical fibers enclosed in a vinyl material. A polyurethane mattress is placed on top of the fiber optic blanket, and a disposable polypropylene cover is placed around the blanket pad and mattress. The fiber optic blanket generates sufficient light output to provide intensive phototherapy which is defined as ≥30µW/cm²/nm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "neoBLUE® blanket LED Phototherapy System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical or standalone performance studies with acceptance criteria for an AI/ML device.

Therefore, many of the requested details regarding acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert involvement for ground truth, and MRMC studies are not present in this document. The device in question is a phototherapy system, not an AI/ML diagnostic or therapeutic device.

Here's an analysis based on the available information and an explanation of why other requested information is not applicable:

1. A table of acceptance criteria and the reported device performance:

The document describes performance specifications that the device meets, rather than acceptance criteria for an AI/ML model's output. The criteria are related to the physical and functional characteristics of the phototherapy system.

Acceptance Criteria (Performance Specification)	Reported Device Performance
Light Spectrum Range	400 – 550 nm (peak wavelength 450-475 nm)
Light Intensity (Intensive Phototherapy definition)	≥30 µW/cm²/nm (for both blanket sizes)
Factory Set Intensity	35 ± 5 µW/cm²/nm
Adjustable Light Output Range	50 to 60 µW/cm²/nm (adjustable)
Expected LED Life	>20,000 hours
Operating Temperature (Light Box)	41° to 86° F (5 to 30°C)
Operating Humidity (Light Box)	10% to 90%, non-condensing
Operating Temperature (Blanket)	41° to 100° F (5 to 38°C)
Operating Humidity (Blanket)	10% to 90%, non-condensing
Storage Temperature	32° to 122° F (0 to 50°C)
Storage Humidity	10% to 90%, non-condensing
Altitude / Atmospheric pressure	700 hPa to 1060 hPa

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document explicitly states "Clinical Tests: N/A" and focuses on non-clinical engineering and performance testing of the physical medical device (phototherapy unit), not a software or AI/ML-based diagnostic system that would require a test set of data.

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)

This information is not applicable. Ground truth, expert consensus, and qualifications of experts are relevant for AI/ML models that interpret medical images or data. The neoBLUE blanket LED Phototherapy System is a physical device delivering light therapy, not an interpretive AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The neoBLUE blanket LED Phototherapy System is a therapeutic device, not an diagnostic AI assistant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as there is no algorithm/AI in this medical device. Its performance is based on its physical specifications and light output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable. For this physical device, "ground truth" relates to measurable physical properties and operational performance tested against engineering specifications and recognized standards (e.g., light intensity measurements, electrical safety).

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary of the Study Proving Device Meets Acceptance Criteria (Non-Clinical):

The study proving the device meets its performance specifications (which serve as "acceptance criteria" for a physical device) was based on non-clinical tests and design verification and validation.

Type of Study: Non-clinical tests, design verification and validation.
Purpose: To ensure the device meets performance specifications and demonstrates equivalence to the predicate device (K103589).
Tests Performed: Specific testing for device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective area, and usability.
Standards Applied: Where appropriate, testing was performed to recognized international and industry standards, including:
- IEC 60601-2-50:2009 +A1 / ED 2.1: 2016-04 (Particular Requirements For The Basic Safety And Essential Performance Of Infant Phototherapy Equipment)
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (General Requirements For Basic Safety And Essential Performance)
- IEC 60601-1-11:2015 (Second Edition) (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- IEC 60601-1-6:2010, AMD1:2013 (Usability)
- IEC 60601-1-2 ED 4.0: 2014-02 (Electromagnetic disturbances)
- An AIM Standard 7351731 Rev 2.0: 2017-02-03 (Electromagnetic disturbances)
Conclusion: The verification and validation summary and risk analysis documentation supported the conclusion that the device is as safe and effective as the predicate device and is substantially equivalent.

No human data, expert review of images, or AI/ML model performance evaluation was part of this submission, as it is for a physical phototherapy device.

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K Number

K103589

Device Name

NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM

Manufacturer

NATUS MEDICAL INCORPORATED

Date Cleared

2011-05-13

(157 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K901987,K051869,K053568

Intended Use

The neoBLUE blanket LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. It can be used in the clinical setting or in the home.

Device Description

A neonatal phototherapy system composed of a mobile light box coupled to a fiberoptic blanket. The re-usable fiberoptic blanket is covered with a mattress and a disposable cover.

AI/ML Overview

The provided information describes a medical device, the neoBLUE blanket LED Phototherapy System, and its non-clinical testing for regulatory approval. However, no acceptance criteria or studies proving the device meets those criteria are explicitly stated in a quantifiable manner that fits the table format requested. Clinical trials are noted as "Not Applicable," and the reported device performance is primarily a list of tests passed and measurements taken, rather than a formal set of acceptance criteria with corresponding results demonstrating compliance.

Therefore, the following response will extract the relevant information from the provided text, but it will be largely descriptive for points that cannot be directly populated in the requested format due to the nature of the source document.

Acceptance Criteria and Device Performance

The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a specific set of numerical acceptance criteria for performance with corresponding study results in the typical sense for AI/medical imaging devices. The "reported device performance" in this context refers to the successful completion and outcomes of specified non-clinical tests.

Acceptance Criteria Category	Specific Criteria (Implicit from Tests Performed)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 for patient-contacting materials (mattress, disposable cover)	Mattress and disposable cover passed Cytotoxicity, Sensitization, and Skin Irritation tests.
Spectral Output	Measurement of peak wavelength and overall spectrum	Peak wavelength of 460 nm (from device description)
Light Irradiance	Sufficient light output for intensive phototherapy	>30 μW/cm²/nm achieved for both large and small blankets.
Effective Surface Treatment Area	Measurement of the area of light emission	504 cm² for the large blanket, 296 cm² for the small blanket.
Electrical Safety	Compliance with IEC 60601-1 (2nd edition) and 60601-1-2 (EMI/EMC)	Tested to ensure compliance with all appropriate sections of IEC 60601-1 and IEC 60601-1-2.
Phototherapy Safety and Performance	Compliance with IEC 60601-2-50 (1st edition)	Tested to ensure compliance with all appropriate sections of IEC 60601-2-50.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document describes non-clinical bench testing and biocompatibility testing of device components, not a test set of patient data.
- Data Provenance: Not applicable, as this refers to physical device characteristics and materials testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a phototherapy system, and its tests relate to physical and electrical performance, and material safety, not diagnostic accuracy based on expert interpretation.
Adjudication method for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not described here.
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:
- No. The document explicitly states "Clinical Tests Performed: Not Applicable." Therefore, no MRMC study or AI-related comparative effectiveness study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a treatment system, not an algorithm, and its performance is evaluated through physical and electrical bench tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Standardized laboratory test results (e.g., cytotoxicity, sensitization, skin irritation assays) against established safety limits.
- For performance metrics (irradiance, effective surface area, spectral output): Direct physical measurements using calibrated equipment.
- For electrical safety: Compliance with international standards (IEC 60601 series).
The sample size for the training set:
- Not applicable. The device is a hardware phototherapy system, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this device.

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