Search Results

The intended use of the modified devices with continue to be provision of tracheal access for airway management in adults.

These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck. which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

Each device described in this present notification will be essentially identical to an existing Shiley Tracheostomy Tube. The only modification to each of these nine marketed devices will be replacement of the current stiff swivel neck plate/flange with a soft, contoured swivel neck plate/flange to facilitate conformity to individual neck anatomies and, thus. improve patient comfort.

This report describes the acceptance criteria and the study that proves the enhanced Shiley Tracheostomy Tubes meet the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the in-vitro performance tests. The data provenance is also not specified, though it can be inferred that the testing was conducted internally by the manufacturer, Mallinckrodt Medical, Inc., as part of their 510(k) submission. These tests are in-vitro performance data (bench testing), not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This section is not applicable. The "ground truth" for this device modification is based on engineering performance standards (CEN Standard Requirements) and internal testing results, not on expert consensus from clinical cases.

4. Adjudication Method for the Test Set

This section is not applicable. The "adjudication" is based on direct comparison of the modified device's performance against established engineering standards and a predicate device, not on expert review of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not an AI-based device, nor is it a diagnostic device that would involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study was not performed and is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an algorithm or AI-based device. Therefore, a standalone algorithm performance study was not done and is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the in-vitro performance tests is based on engineering performance standards and comparison to predicate device performance. Specifically, for the "Neck Plate to Trach Tube Body Attachment Strength," the ground truth is a "minimum 11.3 lbs force" derived from CEN Standard Requirements. For "Tie Strap Hole Strength," there was no specific ground truth requirement, but the modified device's performance was reported alongside the predicate device's performance.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for this device.

Ask a specific question about this device