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Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps are used in the treatment of Hyperbilirubinemia in newborn infants. The lamps are placed in commercially available luminaries that will concentrate the blue light energy.

The Interlectric Bili Blue F20T12/BBY and F40T12/BBY devices are standard 2-foot and 4-foot T-12 fluorescent lamps that contain a phosphor composition that emits blue light energy in the range between 400 - 500 nanometers and produces no energy in the ultraviolet region of the spectrum.

This document describes a 510(k) submission for Interlectric Bili Blue F20T12/BBY and F40T12/BBY fluorescent lamps, used for neonatal phototherapy. It is a submission for a new device that directly compares itself to a predicate device (Philips Special Blue) to establish substantial equivalence.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for a medical device. Instead, the evaluation focuses on comparison testing of the new lamps against the predicate lamps. The "sample" here refers to the actual manufactured lamps of the new device and the predicate device that underwent testing. The document does not provide the exact number of lamps tested.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" because this is a technical comparison of physical devices, not a clinical study involving human subjects or patient data. The testing would have been conducted on the manufactured lamps themselves.

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

This information is not applicable to this type of device submission. Since it's a technical comparison of light bulbs against a predicate device and ANSI standards, there isn't a "ground truth" established by medical experts for a "test set" of patient data. The ground truth would be the established ANSI standards and the technical specifications of the predicate device.

4. Adjudication Method for the Test Set

This is not applicable. There's no clinical "test set" requiring adjudication by experts. The comparison testing would involve objective measurements of physical properties (spectral output, UV radiation, dimensional/electrical characteristics) against defined standards and predicate device performance.

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 is not applicable. This device is a fluorescent lamp, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI performance evaluation was conducted or is relevant.

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

This is not applicable. This device is a physical light source, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is based on:

• Established Clinical Practice: The acceptance that "Phototherapy for treating Hyperbilirubinemia in newborn infants is a well-established clinical practice" and "Exposure to light from blue fluorescent lamps for such treatment was adopted in the United States back in the 1970's" serves as a foundational "ground truth" for the intended use.
• Predicate Device Specifications: The performance characteristics (spectral output, UV safety, etc.) of the Philips Special Blue predicate device serve as a benchmark.
• ANSI Specifications: Adherence to ANSI C78.2-1978 and ANSI C78.1-1991 for dimensional and electrical characteristics serves as a regulatory and industry "ground truth."

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

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

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