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Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea.
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.

The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

This document is a 510(k) Summary for the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP, and it details the device's substantial equivalence to predicate devices, supported by performance data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes for each bench test conducted. It states that "terminally sterilized samples" were tested. For biocompatibility, it mentions "testing was performed on final finished subject device" for sizes 8.5mm to 10.0mm, and testing from the predicate device was leveraged for sizes 3.0mm to 8.0mm.
• Data Provenance: The document does not provide details on data provenance such as country of origin or whether the studies were retrospective or prospective. It describes laboratory bench testing and biocompatibility testing.

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)

This section is not applicable as the document describes bench testing and biocompatibility assessments, which do not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies do. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified international standards.

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

Not applicable. As stated above, this pertains to objective bench and biocompatibility testing following established international standards, not clinical adjudication by experts.

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

No. A MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (an endotracheal tube), not an AI-powered diagnostic tool.

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

Not applicable. This device is an endotracheal tube; it does not involve an algorithm or AI.

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

The "ground truth" for the performance data in this submission consists of the acceptance criteria defined by international consensus standards (ISO 5361, ISO 5356, ISO 18190, ISO 10993-1) and specific test protocols for mechanical properties, biocompatibility, and sterilization, along with human factors standards (EN 62366-1).

8. The sample size for the training set

Not applicable. This document describes the clearance of a physical medical device (an endotracheal tube), not a machine learning model that requires a training set.

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

Not applicable. See point 8.

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