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The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.

The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed.

The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin.

The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BiliCocoon™ Phototherapy System (K163526).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily proving efficacy through a clinical trial. Therefore, the information provided primarily pertains to bench testing and comparison, rather than comprehensive clinical study data as might be expected for novel devices or PMAs.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific statistical endpoint (e.g., accuracy, sensitivity, specificity) relevant to a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance of the predicate device and relevant industry standards. The "reported device performance" is largely described through a comparison against the predicate and adherence to safety and performance standards.

The closest equivalent to "acceptance criteria" for a phototherapy device would be its light output specifications and safety characteristics.

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

This document primarily describes bench testing for hardware and software components, as well as biocompatibility. There is no "test set" in the context of clinical data (e.g., images, patient records) or a machine learning model.

• Sample Size: Not applicable in the traditional sense for a test set of clinical data. Testing involved samples of materials (e.g., disposable cover), components, and the device itself.
• Data Provenance: Not applicable. The testing is based on laboratory measurements and adherence to international standards.

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

Not applicable. There is no clinical "ground truth" derived from expert consensus mentioned in this 510(k) summary for the device's technical performance. Ground truth for biocompatibility is established by standardized lab tests, and for electrical/optical performance by instrumentation and adherence to published standards.

4. Adjudication Method for the Test Set

Not applicable, as there isn't a "test set" requiring expert adjudication in the context of this device's bench testing.

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

No MRMC comparative effectiveness study was mentioned. This device is a phototherapy system, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The BiliCocoon™ Phototherapy System is a medical device, not an AI algorithm. Its performance is directly tied to its physical characteristics and light output.

7. Type of Ground Truth Used

The "ground truth" for the various performance and safety tests conducted were:

• Biocompatibility: Established by reference to ISO 10993 standards and USP 87/88.
• Spectral Output, Light Irradiance, Effective Surface Treatment Area: Established by direct measurement using calibrated equipment.
• Electrical Safety, EMC, Phototherapy Safety/Performance, Home Use, Photobiological Safety: Established by adherence to and compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50, IEC 60601-1-11, IEC 62471) and FDA guidance.

8. Sample Size for the Training Set

Not applicable. This device does not employ a machine learning algorithm; therefore, there is no "training set."

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

Not applicable, as there is no training set for a machine learning algorithm.

Summary regarding the nature of the study:

The provided document describes a bench testing study designed to demonstrate the substantial equivalence of the BiliCocoon™ Phototherapy System to a legally marketed predicate device (K103589, neoBLUE® blanket LED Phototherapy System). The study focuses on comparing technological characteristics and ensuring adherence to relevant safety and performance standards for neonatal phototherapy units. It is not a clinical study or an AI/software performance study in the way the input questions imply.

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