(331 days)
The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.
The subject device is pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) low pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal. 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.
The provided document describes the Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, a direct response to your request, which focuses on acceptance criteria and studies for AI/ML devices, cannot be fully generated from the provided text.
The document does not contain information on:
- Sample sizes for test sets (training or test data)
- Data provenance (country of origin, retrospective/prospective)
- Number of experts, their qualifications, or adjudication methods for ground truth
- Multi-reader multi-case comparative effectiveness studies
- Standalone algorithm performance
- How ground truth was established for "training sets" (as this is not an ML device)
However, I can extract the acceptance criteria and the performance results for the physical device based on the information provided in the "PERFORMANCE DATA" section.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Compliance with ISO 5361:2016 for dimensions (bevel angle, curvature, cuff diameter, connectors) | The subject device met the standard. |
| Print Adherence Test | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Cuff herniation | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Cuff performance | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Inflation line pull test | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Connector pull force | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Kink test | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Tube collapse | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Fluid Seal test | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Radius Curvature test | All testing requirements were met on terminally sterilized unaged and aged samples. |
| MRI Safety and compatibility tests | All testing requirements were met on terminally sterilized unaged and aged samples. |
| Biocompatibility (ISO 10993-1:2009 & FDA guidance) | Testing was performed and listed tests (Cytotoxicity, Implantation, Sensitization, Irritation/Intracutaneous reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Subacute/sub chronic toxicity, Genotoxicity, Particulate matter and VOC) were concluded. The implication is that the device met these criteria. |
| Human Factors / Usability Study (IEC 62366-1:2015) | The device was found to be in conformance with the standard. |
| Sterilization (Ethylene Oxide) | Validation was performed, supporting a 5-year shelf life. |
| Functional and Mechanical tests (compared to predicate) | Met the same acceptance criteria as the predicate device, demonstrating substantial equivalence. |
| Shelf life | 5 years (supported by unaged and aged sample testing). |
Study Information (Based on available document sections):
This document describes a medical device clearance for an endotracheal tube, not an AI/ML powered device. Therefore, the specific questions related to AI/ML device studies (such as sample sizes for AI training/test sets, data provenance for AI, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to the provided content.
The studies conducted were bench-top performance testing, biocompatibility testing, and a human factors/usability study to demonstrate substantial equivalence to predicate devices and compliance with relevant ISO standards.
- Type of Ground Truth Used: For the physical device, the "ground truth" is defined by compliance with established engineering and medical device standards (e.g., ISO 5361:2016, ISO 10993-1:2009, IEC 62366-1:2015) and comparison to the performance of predicate devices. There is no "ground truth" of the kind used for AI/ML validation (e.g., expert consensus on medical images or pathology results).
- Sample Size for Training Set & Ground Truth for Training Set: These concepts are not applicable as this is not an AI/ML device. The "training" for this device would be its design and manufacturing process, optimized to meet design specifications and regulatory standards.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).