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The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients < 10Kg.

The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document describes a 510(k) summary for a medical device called "NeoPIP™ Resuscitation Circuit with PEEP," which is a physical breathing circuit for neonatal resuscitation.

The submission focuses on establishing substantial equivalence to a predicate device based on design, materials, and operational and technological characteristics, not on the performance of a software algorithm or AI model. Therefore, directly answering the questions related to AI/ML performance metrics, sample sizes for test/training sets, experts, and ground truth as outlined in the prompt is not possible from the provided text.

Here's a breakdown of why each requested point cannot be addressed:

1. Table of acceptance criteria and reported device performance: Not applicable. The document discusses "performance data" in the sense of demonstrating equivalence to a predicate device, not in the context of specific quantitative performance metrics for an AI/ML system.
2. Sample size for test set and data provenance: No test set is mentioned, as this is a hardware device.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for AI/ML is not relevant for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as it's not an AI-assisted diagnostic tool.
6. Standalone (algorithm only) performance: Not applicable, as there is no algorithm described.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

• Intended Use: An accessory to add positive end expiratory pressure (PEEP) breathing capability to a T-Piece Resuscitator for neonatal patients < 10Kg.
• Substantial Equivalence: Claimed based on similarity in intended use, design, operational and technological characteristics, and principles of operation to legally marketed predicate devices (K070416 NeoPEEP Neonatal Resuscitation Circuit with PEEP and Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP).
• Performance Data (for equivalence): States that the technological characteristics (design and materials) are the same as the predicate device and that performance data demonstrate equivalence to the predicate device. This implies engineering or functional testing to ensure the device operates as expected and similarly to the predicate, not AI/ML performance evaluation.

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