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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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