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The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability. The valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient in labor and delivery environments. It is suitable for newborn patients from birth to 1 month of age (maximum body weight of 10 kg (22 lb)). It is intended exclusively for use in combination with the Resuscitaire Radiant Warmer.

The VentStar Resuscitaire CEU is a prescription device.

The VentStar Resuscitaire CEU with PEEP valve is indicated as accessory to add positive end expiratory pressure breathing capability. The valve is designed into the T-Piece of the breathing circuit with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The provided text describes the 510(k) summary for the Dräger VentStar Resuscitaire CEU, a medical device for neonates. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving the device meets specific acceptance criteria in the way a new, innovative AI/software device would. Therefore, many of the requested elements for an AI study are not applicable or cannot be extracted from this document.

However, I can extract information related to the device itself, the comparison to the predicate, and the type of testing performed.

Summary of Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

The acceptance criteria for the VentStar Resuscitaire CEU are rooted in demonstrating substantial equivalence to a predicate device, the NeoPeep Neonatal Resuscitation Circuit. The "acceptance criteria" here are implicitly that the key performance parameters of the new device match or are functionally equivalent to the predicate.

Study Information (Based on provided document):

1. Sample size used for the test set and the data provenance: Not applicable. This document describes a medical device, not an AI/software device that would have a "test set" in the context of data. The testing was primarily non-clinical bench testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As this is not an AI/software device, there is no "ground truth" derived from expert consensus on images or data.
3. Adjudication method (e.g., 2+1, 3+1, none) 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 physical medical device, not an AI or software component requiring MRMC studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a "test set" for an AI device. The "ground truth" for this device's performance would be established by physical measurements and adherence to engineering standards (e.g., ISO, internal specifications) during the bench testing. The regulatory ground truth is its substantial equivalence to the legally marketed predicate.
7. The sample size for the training set: Not applicable. This is a physical medical device; it does not have a "training set" in the AI sense.
8. How the ground truth for the training set was established: Not applicable.

Additional Information from the Document regarding "Study":

• Device Performance Assessment: The assessment of the VentStar Resuscitaire CEU involved non-clinical bench testing.
• Standards Used for Bench Testing:
  • ISO 5356 Anesthetic and Respiratory Equipment - Conical Connectors Part 1
  • ISO 5367 Breathing tubes intended for use with anesthetic apparatus and ventilators
  • System compatibility testing
• Biocompatibility Testing: Performed per ISO 10993 - Biological Evaluation of Medical Devices Parts 1, 5 & 12.
• Conclusion of the Study (Bench Testing): "In summary Dräger Medical AG & Co. KG has demonstrated that the proposed device is safe and effective and is substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the NeoPeep Neonatal Resuscitation Circuit."

In essence, the "study" demonstrating the device meets "acceptance criteria" for regulatory clearance (510(k)) was a series of non-clinical bench tests and biocompatibility tests designed to show that the VentStar Resuscitaire CEU performs equivalently to its predicate device and meets relevant safety standards for its classification.

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