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The BEVER™ Reinforced Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during anesthesia. The product may be used where the patient's neck is likely to be moved or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

BEVER™ Reinforced Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm10.0 mm in 0.5 mm increments
BEVER™ Reinforced Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm7.0 mm in 0.5 mm increments
BEVER " Reinforced Endotracheal tube is an Endotracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen.
The BEVER™ Reinforced Endotracheal tube is sterile, single use device supplied with a standard 15 mm connector. It is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, cuff, inflating system (including inflating tube, valve and pilot balloon) and 15 mm connector. The uncuffed tube is composed of main tube and 15 mm connector. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.

The provided document is a 510(k) summary for the BEVER™ Reinforced Endotracheal Tube. It primarily demonstrates substantial equivalence to predicate devices based on design, materials, and compliance with various international standards for medical devices, rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or AI-driven device.

Therefore, the requested information, particularly regarding sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/diagnostic studies, is not applicable to this type of submission. This document describes a traditional medical device (an endotracheal tube), not a software or AI/ML-based device that would typically involve such studies.

However, I can extract the "acceptance criteria" and "reported device performance" in the context of compliance with relevant standards and the conclusions drawn for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For the remaining points, as explained, the context of this 510(k) summary for a reinforced endotracheal tube does not involve the type of diagnostic or AI performance studies implied by these questions. This is a traditional device submission focused on material conformity, biocompatibility, and sterilization validation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission focuses on compliance with physical, chemical, and biological standards for a manufactured medical device, not on data analysis from a "test set" of patients or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth establishment by experts is not relevant for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring expert adjudication was described.

5. 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. No MRMC or AI-assisted study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is not an algorithm and does not have a "standalone" performance in that sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for this device's safety and effectiveness relies on compliance with established ISO and AAMI standards for physical properties, materials, biocompatibility, and sterility.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

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