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The NeoPIP Infant Resuscitation Unit is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.

The NeoPIP Infant Resuscitation Unit is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.

This 510(k) submission for the NeoPIP Infant Resuscitation Unit does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and performance.

Here's why and what information is missing:

• Type of Submission: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific performance against pre-defined acceptance criteria in the same way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.
• Focus on Substantial Equivalence: The document primarily focuses on stating the intended use, device description, and claiming substantial equivalence to the predicate device (K892885 Fisher & Paykel, Neopuff Infant Resuscitator).
• Lack of Performance Data: There is no section detailing specific performance metrics, test methods, results, or acceptance criteria within the provided text. The document states "Performance Standards: None applicable," which further indicates that the submission doesn't rely on meeting specific quantitative performance metrics defined by external standards for approval.
• No Clinical Study Description: There is no mention of any clinical study, either standalone or comparative, involving human readers, experts, or ground truth establishment. The document describes a "manually operated, gas powered device," suggesting its evaluation would revolve around engineering and functional testing rather than image-based diagnostic performance.

Therefore, I cannot provide the requested table and study description based on the input. The provided text is a regulatory clearance letter and a summary of the device, not a detailed performance study.

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