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VentStar Resus heated (N) (MP17030): VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.

The product allows short-term ventilation with humidified breathing gas and additional PEEP.

It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.

The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

VentStar Autobreath heated (N) (MP17031): VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.

The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP.

The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.

The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

The subject devices, VentStar Autobreath heated (N) (MP17031) and VentStar Resus heated (N) (MP17030), are two heated disposable single limp breathing circuits with humidifier chamber for connection to the humidifier MR850 by Fisher and Paykel (K073706), for neonatal patients with a maximum body weight of 10 kg for use with the Dräger BabyRoo TN300 (K230278) and Dräger Resuscitaire (K120642).

The VentStar Resus heated (N) MP17030 is equipped with a manual PEEP valve which enables the setting of a PEEP by the operator directly. The operator can control the inhalation and exhalation.

The VentStar Autobreath heated (N) MP17031 is equipped with an automatic PEEP valve. With the Autobreath function a respiratory rate can be adjusted on the resuscitation module and a machine controlled consistent inspiration rate can be applied to the patient.

The heated breathing circuits are intended for conveying breathing gases (air and/or oxygen) from a breathing gas source (resuscitation module) to the humidifier chamber and finally to the patient.

Both breathing circuits are designed for a flow range from 5 to 15 L/min.

The heating of the hoses is done by using electrical heating wires inside the wall of the hoses. These wires have specific electrical resistances to generate a specific heating power. The heating plate of the humidifier chamber is positioned at the heater of the humidifier.

The provided FDA 510(k) Clearance Letter for the VentStar Resus and Autobreath Heated Devices (K242769) outlines the regulatory approval process for these medical devices. However, it does not contain information related to software, artificial intelligence (AI), diagnostic studies, or the acceptance criteria for such studies.

The document pertains to the physical characteristics, safety, and functionality of heated disposable breathing circuits for neonatal ventilation. The performance data section refers to non-clinical testing covering mechanical, thermal safety, environmental conditions, electrical safety, electromagnetic compatibility, functional verification, and performance capacity and accuracy, all conducted against established medical device standards.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance related to AI, ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies, as none of this information is present in the provided text.

The information primarily focuses on:

• Device Description: Heated disposable breathing circuits for neonatal patients.
• Intended Use: Conveying humidified breathing gas from a resuscitation module to a patient.
• Comparison to Predicate Devices: Demonstrating substantial equivalence based on physical and functional characteristics.
• Performance Data: References to compliance with various ISO and IEC standards for electrical safety, EMC, functional performance, and biocompatibility.

**To directly answer your numbered points based solely on the provided document: **

1. A table of acceptance criteria and the reported device performance: Not provided in the document in the context of diagnostic performance or AI. The performance section mentions compliance with various standards (e.g., IEC 60601-1, ISO 5367), implying that the acceptance criteria are adherence to these established engineering and safety standards, rather than diagnostic accuracy metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable or not provided. The testing discussed is non-clinical (mechanical, electrical, etc.), not a data-driven diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI models (e.g., expert reads of medical images) is not relevant to the described device testing.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks. The device is a breathing circuit, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no mention of an algorithm or AI.
7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. Ground truth for this device would be defined by engineering specifications and physical measurements (e.g., resistance levels, heating efficiency, material composition).
8. The sample size for the training set: Not applicable, as there is no AI/machine learning component mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (breathing circuits) and its compliance with safety and performance standards for hardware, not a software/AI driven diagnostic tool. Therefore, the questions related to AI performance, ground truth establishment, and clinical study methodologies are not addressed by the provided text.

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