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The Pacifier Activated Lullaby (PAL®) encourages and reinforces effective non-nutritive sucking of premature infants. This is accomplished by giving positive feedback to the infant in the form of music or a mother's voice as auditory input in direct response to sucking.

The Pacifier Activated Lullaby ("PAL®") has a player module, pacifier sensor module and power supply. The pacifier sensor module senses the strength and duration of an infant's sucking on an attached pacifier and responds with music or a recorded sound (i.e. mother's voice) contingent to the infant's sucking. The pacifier module consists of a wired transmitter with a built in pressure transducer that connects to the pacifier and a receiver. The receiver decodes the signal and plays music or a recorded sound for a predetermined length of time via a speaker to the infant contingent on his/her sucking on the pacifier transmitter. This action occurs when the sucking strength and duration exceeds preset values. The user can control the sensitivity of the transducer.

This application describes modifications to the FDA cleared K010388 P.A.L. System.

The provided document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for clinical performance evaluation (e.g., sensitivity, specificity, accuracy against a ground truth).

This document is a 510(k) Premarket Notification for the Pacifier Activated Lullaby (PAL®). Its primary purpose is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not to prove clinical efficacy or accuracy against specific performance metrics with a clinical study.

The "Performance Testing" section (I) lists several types of engineering and compliance tests, but these are related to software, electrical safety, electromagnetic compatibility, and physical stability, rather than clinical performance for its stated indication. The document explicitly states: "Differences do not raise different issues of safety or performance, and issues of safety are assessed in the risk analysis. The Pacifier Activated Lullaby (PAL®) is expected to perform per its Indications for Use and is substantially equivalent to the predicate device."

Therefore, I cannot populate the table or answer the other questions as the information is not present in the provided text. The document focuses on regulatory compliance and substantial equivalence, not a clinical study proving specific performance criteria.

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Infant radiant Warmers provide infrared heat in a controlled manner to infants who are unable to maintain thermoregulation based on their own physiology. Infant radiant Warmers may be used to facilitate the newborn's transition to the external environment or to rrovide a controlled open microenvironment.

The Lullaby™ Warmer is a radiant warmer which provides a micro-environment for a premature, new born baby which otherwise might have very little chance of survival as it will not be able to maintain, by itself, its core body temperature. The Lullaby™ Warmer provides a means for the care giver to monitor the baby continuously by giving timely feedback via the different alarm systems and servo controlled thermal feedback mechanism while maintaining a pre-set temperature and thus ensures that the neonate slowly develops the internal organs to enable it to maintain its body temperature.

The Lullaby™ Warmer is an infant radiant warmer. The provided documents detail its premarket notification (510(k)) summary, indicating that it did not require clinical studies for substantial equivalence. Therefore, the device does not rely on a study demonstrating how it meets acceptance criteria based on human expert performance or clinical outcomes. Instead, its acceptance is based on non-clinical tests and compliance with recognized standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "The subject of this premarket submission, Lullaby™ Warmer, did not require clinical studies to support substantial equivalence."
Therefore, there was no "test set" in the context of clinical data, no sample size of patients, and no data provenance from human subjects for this device's 510(k) submission. Acceptance was based on engineering and performance verification testing of the device itself.

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

Not applicable. As no clinical studies were required, there was no test set involving human subjects where expert ground truth was established for the device's performance with patients. Ground truth in this context would relate to engineering specifications and performance benchmarks, which are established by design and testing engineers.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring 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

Not applicable. The Lullaby™ Warmer is an infant radiant warmer, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. The Lullaby™ Warmer is a physical medical device, not an algorithm. Its performance is demonstrated through its functional capabilities, safety features, and compliance with manufacturing and performance standards.

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

The "ground truth" for the Lullaby™ Warmer's acceptance is based on engineering specifications, technical performance benchmarks, and compliance with recognized voluntary standards. This includes verification that the device maintains a pre-set temperature, provides timely feedback via alarm systems, and operates within specified electrical, mechanical, and safety parameters.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of machine learning or clinical data. The device's design and manufacturing process would involve internal testing and validation against specifications.

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

Not applicable. As no training set (in the machine learning sense) was used, no ground truth needed to be established for it. The "ground truth" for the device's functionality is its adherence to its design specifications and the regulatory requirements for infant radiant warmers.

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The Lullaby The LED Phototherapy System is used for the treatment of indirect hyperbilirubinemia in term and pre-term infants, in a hospital environment - NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner.

The Lullaby 10 LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner.

The Lullaby The LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

The Lullaby™ LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. The system can be used for infants in a bassinet, incubator, open bed or radiant warmer. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum range. The Lullaby™ LED Phototherapy System consists of a lamp unit with 10 blue LED lamps mounted on a roll stand. The lamp unit consists of a lightweight plastic light enclosure. It can be adjusted vertically and tilted if required. The light enclosure can be tilted up to approximately 90° from the horizontal about it pivot axis. The height of the pedestal can be adjusted to change the vertical position of the lamp unit. The base of the Lullaby™ LED Phototherapy System is designed to slide conveniently under a bassinet, incubator, open bed, or radiant warmer. The lamp unit is designed as a table top style to place directly on the incubator

This 510(k) premarket notification describes the Lullaby™ LED Phototherapy System, a device intended for the treatment of neonatal hyperbilirubinemia.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the proposed Lullaby™ LED Phototherapy System with its predicate device, the Lullaby™ Phototherapy System (K071828), to establish substantial equivalence. The performance factors listed act as the de facto acceptance criteria.

Note on "Acceptance Criteria": In the context of a 510(k) for a substantially equivalent device, the "acceptance criteria" are typically met by demonstrating that the new device performs as well as or better than the predicate device for key performance characteristics, or that any differences do not raise new questions of safety or effectiveness. The table above uses the predicate device's performance as the benchmark for these criteria.

2. Sample Size and Data Provenance

The document states: "The subject of this premarket submission, Lullaby™ LED Phototherapy System, did not require clinical studies to support substantial equivalence." Therefore, there is no patient-specific test set or associated sample size for demonstrating clinical performance. The evaluation was based on non-clinical testing and engineering verification.

The data provenance for the non-clinical tests would be internal to Wipro GE Healthcare Private Ltd. and performed during the device's development and testing phases in India (based on the submitter's address).

3. Number and Qualifications of Experts for Ground Truth

Since no clinical studies were conducted and the device's substantial equivalence was based on non-clinical engineering and performance testing, there were no experts used to establish ground truth for a test set in a clinical context. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation based on the provided technical documentation.

4. Adjudication Method

As there was no clinical test set requiring expert interpretation or consensus, there was no adjudication method used in this context.

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

No MRMC comparative effectiveness study was done. The submission explicitly states that clinical studies were not required.

6. Standalone (Algorithm Only) Performance

This device is a physical medical device (phototherapy system), not an algorithm or AI software, therefore, the concept of "standalone (algorithm only) performance" does not apply. The performance evaluation focused on the physical characteristics and functionality of the system itself.

7. Type of Ground Truth Used

The "ground truth" for this submission was established through engineering verification and performance testing. This involved:

• Testing of electrical, mechanical, and safety parameters.
• Reliability testing.
• System design verification protocols.
• Compliance with voluntary standards.

The results of these tests demonstrated that the device met all design requirements and performance claims, allowing it to be deemed substantially equivalent to the predicate.

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. Therefore, there is no training set sample size to report.

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

As there is no training set, this question is not applicable.

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The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device is intended for professional use only by trained clinicians.

The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device consists of a freestanding lamp that delivers specific wavelength light to the patient positioned below the lamp.

This document describes the GE Healthcare Lullaby™ Phototherapy System, a device intended for the treatment of neonatal hyperbilirubinemia (neonatal jaundice).

Acceptance Criteria and Device Performance:

The document does not explicitly state numerical acceptance criteria for the Lullaby™ Phototherapy System's performance in treating neonatal hyperbilirubinemia. Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device.

Study Details:

The document states: "Clinical Tests: None required." This indicates that no specific clinical study was conducted as part of this 510(k) submission to demonstrate the device's performance against specific acceptance criteria. The approval is based on the established safety and effectiveness of the phototherapy treatment modality itself and the device's substantial equivalence to a predicate device.

Therefore, many of the typical study-related questions are not applicable to this submission.

1. Sample size used for the test set and the data provenance: Not applicable. No test set from a clinical study was used for performance evaluation since no clinical tests were required.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set was established as no clinical tests were performed.
3. Adjudication method for the test set: Not applicable.
4. 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 is a phototherapy device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm. Its performance is inherent in its physical and functional design.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a specific study within this submission. The ground truth for the effectiveness of phototherapy for neonatal hyperbilirubinemia is implicitly based on the long history of safe and effective use established in traditional clinical practice for this type of treatment.
7. The sample size for the training set: Not applicable. No training set for an algorithm was used.
8. How the ground truth for the training set was established: Not applicable.

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