(122 days)
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.
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.
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.
§ 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).