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The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-shelf AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home.

The BiliBee LED Phototherapy System is both a battery-operated device or AC/DC regulated power that provides therapeutic light through an LED illuminator panel for the treatment of neonatal jaundice (hyperbilirubinemia). Treatment is applied by placing the patient (neonate) on the BiliBee LED Phototherapy System panel with a disposable sheath separating the child from the panel's surface. The patient's eyes do not need to be covered during treatment. Treatment is intended to be applied 24 hours a day until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Treatment time is expected to range from 3 days to 3 weeks. Phototherapy treatment of neonatal jaundice using the BiliBee LED Phototherapy System can be applied at home or in a hospital.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (Bilibee LED Phototherapy System), which primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's description and intended use.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets specific performance criteria.
• Information on sample sizes for test sets or training sets.
• Data provenance, details about experts, adjudication methods, MRMC studies, or standalone performance.
• The type of ground truth used or how it was established.

The document states that the device "does not raise any new safety concerns" because it uses the "same operating principle of delivery of light to degrade bilirubin" as its predicate devices. This implies that the performance aspects related to light output are expected to be similar or equivalent to established standards for phototherapy devices, but no specific performance study results, acceptance criteria, or statistical analyses are presented in this summary.

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The Bili-Tx is intended to treat hyperbilirubinemia through phototherapy in a home or hospital/institutional environment.

The Bili-Tx is a phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal jaundice (hyperbilirubinemia). The blue LEDs emit light in the range of 400-550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered effective for the degradation of bilirubin'. The blue LEDs used by the Bili-Tx do not emit significant energy in the ultraviolet (UV) region of the spectrum or infrared (IR) region of the spectrum, so there is no concern about UV or IR exposure and excessive warming of the neonate due to use of the device.

The Bili-Tx has two different treatment options for providing phototherapy, which includes: phototherapy by fiber optic light panel that directly contacts the neonate's body and phototherapy by overhead light that is positioned over the neonate. The same Bili-Tx light source is used to provide phototherapy light for both options.

In the fiber optic light panel treatment option, the Bili-Tx consists of the light source, fiber optic cable bundle used to transmit the light from the light source to the light panel, fiber optic light panel, and disposable fiber optic light panel cover. There are two styles of fiber optic light panels that may be used, which include a longer light panel that wraps around the neonate and a shorter light panel that the neonate's body rests on.

The Bili-Tx uses the same fiber optic light panels, including the permanently attached fiber optic cable bundle, and disposable fiber optic light panel covers that were cleared with the Wallaby 3 in K991627.

This treatment option does not require protective eyeshades to be worn by the neonate receiving phototherapy as the light panel is focused by the clinician/caregiver providing therapy.

In the overhead light treatment option, the Bili-Tx consists of the light source and a standard intravenous (IV) pole and bracket used to support the light source over the neonate. The Bili-Tx light source used in the overhead light option is the same light source used in the fiber optic light panel option. As with all overhead phototherapy lights, protective eyeshades must be used to protect the neonate's eyes from excessive light exposure.

The provided text describes a 510(k) submission for a medical device called Bili-Tx, a neonatal phototherapy device. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than proving safety and efficacy through extensive clinical studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is largely not applicable to this 510(k) document. The focus of this submission is on design verification testing and demonstrating that the device is as safe and effective as previously cleared devices.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

1. Table of acceptance criteria and reported device performance:

• Not Applicable in the traditional sense for this 510(k). The submission states: "The functionality of the design of the device was verified through design verification testing. The safety of the design will be assured by the completion of IEC 60601-1-2 testing. Efficacy of therapy is established through peer reviewed clinical literature."
• This implies that the acceptance criteria would be related to meeting the performance specifications of the design verification tests and compliance with the IEC standard. However, the specific quantitative acceptance criteria or detailed results of these tests are not provided in this summary. The "reported device performance" is not explicitly quantified here beyond stating its intended function (delivers high-intensity blue light, 400-550 nm, peak 450-470 nm).

2. Sample size used for the test set and the data provenance:

• Not Applicable/Not provided. No clinical "test set" with a sample size as typically understood for clinical efficacy studies is mentioned. The testing described is design verification and compliance testing (IEC 60601-1-2), which doesn't typically involve human subjects or a specified "test set" in the context of diagnostic or treatment efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable/Not provided. As there's no clinical "test set" described for which ground truth would be established, this information is not relevant to this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable/Not provided.

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:

• Not Applicable. This device is a phototherapy unit, not an AI-powered diagnostic or treatment assistance tool. MRMC studies are not relevant to this type of device.

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

• Not Applicable. This is a hardware device for phototherapy, not an algorithm, so "standalone" performance in this context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable in the context of clinical efficacy data. The "efficacy of therapy is established through peer reviewed clinical literature." This implies that the scientific community's understanding of phototherapy for hyperbilirubinemia, supported by existing research (e.g., the Vreman et al. paper cited), serves as the "ground truth" for the treatment principle. For the device itself, the ground truth would be compliance with engineering specifications and safety standards.

8. The sample size for the training set:

• Not Applicable/Not provided. There is no "training set" for an algorithm, as this is a hardware device.

9. How the ground truth for the training set was established:

• Not Applicable/Not provided. (See point 8).

Summary of Relevant Information from the Document:

• Acceptance Criteria (Implied):
  • Successful completion of design verification testing (specifics not detailed).
  • Compliance with IEC 60601-1-2 safety standards.
  • Mitigation of all identified hazards as per the Risk Traceability Matrix.
• Study Proving Acceptance Criteria Met:
  • Design Verification Testing: "The functionality of the design of the device was verified through design verification testing." (Details of testing or results not provided in summary).
  • Safety Testing: "The safety of the design will be assured by the completion of IEC 60601-1-2 testing." (Completion is promised, results not provided).
  • Efficacy: "Efficacy of therapy is established through peer reviewed clinical literature." (The submission relies on existing scientific knowledge about phototherapy for hyperbilirubinemia, evidenced by the citation provided: Vreman HJ, et al. Light-emitting diodes: a novel light source for phototherapy. Pediatric Research. 1998; 44(5):804-809).
• Data Provenance for Design/Safety: Likely internal lab testing by Respironics, Inc.
• Ground Truth for Efficacy (General Principle): Peer-reviewed clinical literature on the effectiveness of blue light phototherapy for hyperbilirubinemia.

In conclusion, this 510(k) submission demonstrates a "modified design" of a previously cleared device, relying on substantial equivalence to predicates and engineering/safety testing, rather than presenting new clinical study data with detailed acceptance criteria for a novel therapeutic or diagnostic claim.

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