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The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.

The Neonatal Phototherapy System, Model: KANGALITE is a wearable phototherapy system that consists of six components: Light Source with AC Power Cord, Dual Fiber Optic Panels (Standard accessory) /Single Fiber Optic Panel (optional accessory), Swaddle, Strap, Disposable Covers and Table Mounting Clip (optional accessory). The Neonatal Phototherapy System, Model: KANGALITE delivers a narrow band of high-intensity blue light emitting diode (LED), in order to provide phototherapy treatment for neonatal hyperbilirubinemia.

The Neonatal Phototherapy System, Model: KANGALITE Light Source contains a blue LED which emits light in the range 400-500 nm (peak wavelength 455±10 nm). The system gives only one blue light irradiance output level which is not adjustable. This blue light is directed through the optical fiber bundle to the illuminating area of the Fiber Optic Panel where the newborn receives blue light therapy.

The Fiber Optic Panel is inserted into the Disposable Cover and is placed in a soft and comfortable Swaddle, while the baby is wrapped inside to receive phototherapy. Baby is allowed to receive kangaroo care. Besides, compare to conventional phototherapy, no eye protection for the baby is required as blue light will not leak out when properly set up.

The light output (>30 µW/cm²/nm) is sufficient to provide intensive phototherapy which is defined as in the American Academy of Pediatrics (AAP) standard.

Average irradiance for:

Dual Fiber Optic Panels: 50 µW/cm2/nm (±25%);

Single Fiber Optic Panel: 60 uW/cm2/nm (±25%).

The spectrum range of the blue LED light matches with the spectral absorption of bilirubin. Under blue light irradiation, subcutaneous bilirubin absorbs strongly in the blue region of the light spectrum and converts into less lipophilic waste products which can be excreted through the bile or urine without the need for conjugation.

The Neonatal Phototherapy System, Model: KANGALITE can be directly connected to nominal voltages readily available throughout the world as the Light Source is affixed with a wide-range medical adaptor, rated from 100-240 VAC and 50/60 Hz. It converts the power to 15 VDC to power up the Light Source.

The provided text describes a 510(k) premarket notification for a medical device, the Neonatal Phototherapy System, Model: KANGALITE. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/device.

Therefore, many of the requested details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI models or new clinical devices, are not explicitly provided in this 510(k) submission.

Here's a breakdown of what can be inferred or stated based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit acceptance criteria with numerical performance targets typical for clinical efficacy studies (e.g., sensitivity, specificity, or improvement in bilirubin levels). Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to a previously cleared predicate device (Bili-Tx, K070180) through various non-clinical tests and comparisons of technological characteristics.

The "reported device performance" is largely qualitative, asserting that the device meets relevant safety and performance standards established for such phototherapy systems.

Here's what can be extracted regarding performance and comparison:

The acceptance criteria are implicitly met if the KANGALITE device demonstrates equivalent or superior performance based on these technical specifications and safety standards, and if any differences do not raise new questions of safety or effectiveness.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical data used for performance claims typical for AI-based devices or new therapeutic modalities. The testing described is primarily non-clinical bench testing (e.g., electrical safety, EMC, biocompatibility, light performance).

• Test Set Sample Size: N/A (no clinical test set)
• Data Provenance: Not applicable for clinical study data. The non-clinical tests were performed to established medical device standards.

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

• Number of Experts: N/A (no clinical test set requiring expert ground truth)
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: N/A (no clinical test set with human adjudication)

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:

• MRMC Study: No. This device is a phototherapy system, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

• Standalone Performance: Not applicable in the context of an AI algorithm. The device's performance is "standalone" in the sense that it delivers phototherapy directly, and its performance is validated through bench testing against established standards for its physical and functional characteristics.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by adherence to recognized international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and phototherapy equipment), and the device's measured performance against the specifications deemed safe and effective for its intended use and equivalent to the predicate.

8. The Sample Size for the Training Set:

• Training Set Sample Size: N/A (no clinical data training for an AI model as this is not an AI device).

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

• Ground Truth Establishment for Training Set: N/A (Not an AI device using a training set).

Summary of the Study:

The "study" presented in this 510(k) notification is primarily a bench testing and comparative analysis rather than a clinical trial or AI model validation study. Its purpose is to demonstrate that the Neonatal Phototherapy System, Model: KANGALITE, is substantially equivalent in terms of safety and effectiveness to a legally marketed predicate device (Bili-Tx, K070180). This is achieved by showing that:

• The new device has the same intended use as the predicate device (though with a slightly more specific target population and additional contraindications explicitly stated, which are considered to not raise new safety concerns).
• The technological characteristics are sufficiently similar. Where differences exist, the submission explains why these differences do not raise new questions of safety or effectiveness (e.g., longer LED lifetime, different connection mechanism, higher IP rating for home use, larger illuminated area).
• The device conforms to relevant electrical safety, EMC, biocompatibility, and phototherapy equipment standards through detailed non-clinical bench testing.

Conclusion from the document: "Based on the performance testing, comparison, and risk analysis in this submission, the subject device Neonatal Phototherapy System, Model: KANGALITE is substantially equivalent to the predicate device K070180."

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