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The Bright Embrace Model SBL60 phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath and around the neonate. The Bright Embrace can be used in a clinical setting or in the home.

The Bright Embrace Model SBL60 is a single-patient, portable phototherapy light that was specifically designed to incorporate these features:

• 1. high intensity blue light over a large body surface area as recommended by the American Academy of Pediatrics (AAP);
• 2. the ability to hold the newborn during treatment;
• 3. single patient use to minimize cross-contamination in hospitals and to facilitate home care logistics:

The Bright Embrace Model SBL60 delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia, also called newborn jaundice. The Bright Embrace Model SBL60 is designed to provide phototherapy treatment from a wrap-around design that provides light from underneath, the sides and partially the front of the newborn to achieve a large body surface area of treatment.

The blue LEDs used in the Bright Embrace Model SBL60 emit light in the range of 430-510nm (peak wavelength 480nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the desirable degradation of bilirubin under the exposed skin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the newborn. As with most phototherapy devices, protective eye shades or goggles must be used to protect the newborn's eyes from excessive light exposure.

The Bright Embrace Model SBL60 is a neonatal phototherapy light intended for the treatment of neonatal hyperbilirubinemia.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing performed on "prototype devices" or "a Bright Embrace prototype Model SBL60."

• Irradiance test: One prototype device was used. Measurements were taken from 30 points across 10 adjacent LED "spotlights."
• Body Surface Area (BSA) test: One term-sized neonatal manikin and one premature-sized infant manikin were used.
• Temperature test: One prototype device was used. Temperatures were measured at 12 locations.
• Environmental Temperature/Humidity test: Two prototype devices were used.
• Leakage test: One "working prototype" was used.

The data provenance is internal to Physician Engineered Products, Inc. (PEP). These are "Lab Test Forms" and "non-published PEP outcome studies" mentioned for the duration of treatment, implying internal, retrospective data for some aspects. No specific country of origin is mentioned beyond the company's US address.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the non-clinical tests was established by adherence to recognized international standards (IEC, UL, CUL, DEMKO, CE, PSE, CB Report, VCCI, EN series) and recommendations from the American Academy of Pediatrics (AAP). While these standards and recommendations are established by experts, no individual experts were explicitly used to establish "ground truth" for these specific device performance tests. The tests themselves are objective measurements against predefined thresholds.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective physical measurements against established standards and guidelines (e.g., temperature, irradiance, electrical safety). There is no human interpretation or subjective assessment of results that would require an adjudication method like 2+1 or 3+1.

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

No MRMC comparative effectiveness study was mentioned. The device is a phototherapy light, not an imaging or diagnostic device that typically involves human readers.

6. Standalone Performance

Yes, standalone performance was assessed through the various non-clinical tests. These tests (irradiance, BSA, temperature, environmental, leakage, electrical safety, EMC, infant phototherapy equipment safety, and radiation safety) evaluate the device's technical specifications and performance independently.

7. Type of Ground Truth Used

The ground truth for the device's performance was based on:

• Established standards: International Electrotechnical Commission (IEC), Underwriters Laboratories (UL), Canadian Underwriters Laboratories (CUL), Dansk Elektroteknisk Komite (DEMKO), Conformité Européenne (CE), Product Safety Electrical Appliance and Material (PSE), CB Scheme, Voluntary Control Council for Interference (VCCI), European Norms (EN) for electrical safety, electromagnetic compatibility, and specific medical device requirements for infant phototherapy equipment.
• Clinical guidelines: Recommendations from the American Academy of Pediatrics (AAP) for "intense phototherapy" levels and treatment of "as much body surface area as possible."
• Internal specifications: Based on the device's design (e.g., LED wavelength range, hour meter functionality).

8. Sample Size for the Training Set

The document does not mention any "training set." This type of device (phototherapy light) does not use machine learning or AI that would require a training set in the conventional sense. The "training" for this device refers to its design and engineering to meet specific physical and performance parameters.

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

Not applicable, as there is no "training set" for this type of medical device. The "ground truth" for the device's design and manufacturing process would be based on engineering principles, material science, and adherence to relevant safety and performance standards.

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