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The device is intended for use in providing tracheal access for airway management.

The subject devices are single patient use tracheostomy tubes that are intended to provide an artificial airway for airway management. It is available in multiple neonatal and pediatric sizes, all of which are available either cuffless or with a TaperGuard™ cuff. The products have a radiopaque tube with a clear flange and standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. The products are not made with natural rubber latex or DEHP.

The provided text is a 510(k) summary for a medical device, the Shiley™ Neonatal/Pediatric Tracheostomy Tube. It details the device's characteristics, intended use, and comparisons to predicate devices, along with the performance testing conducted to demonstrate substantial equivalence.

However, the document specifically states "N/A - Clinical evidence was not necessary to show substantial equivalence." This means that the submission did not include a clinical study in the traditional sense, especially not one involving human subjects that would typically require the establishment of an AI model's performance against human readers or a ground truth derived from expert consensus or pathology for a diagnostic or AI-driven device.

Therefore, many of the requested elements for AI model evaluation (like multi-reader multi-case studies, expert adjudication, training set details, etc.) are not applicable to this 510(k) submission as it concerns a physical medical device (tracheostomy tube) and not an AI/software device.

I can, however, extract information regarding the acceptance criteria and the studies that were performed to prove the device met those criteria for this type of medical device.

Acceptance Criteria and Device Performance for the Shiley™ Neonatal/Pediatric Tracheostomy Tube

This 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (tracheostomy tube) to existing predicate devices based on design, materials, and performance through non-clinical testing. It does not involve an AI model or diagnostic performance evaluation that would necessitate clinical studies, multi-reader analyses, or expert ground truth establishment in the way described in the prompt's questions.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria (Tests Performed) and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated for each test, but standard for medical device bench testing and biocompatibility involves a sufficient number of samples to ensure statistical validity and representativeness of the manufacturing process. These are typically small, controlled batches for verification.
• Data Provenance: Laboratory test results from internal or contracted testing facilities for the subject device. These are prospective tests performed specifically for this 510(k) submission, not retrospective patient data. The country of origin for the testing itself is not specified, but the applicant (Covidien) is based in Boulder, CO, USA.

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

• N/A. The testing conducted for this device is physical and material performance testing, not a diagnostic or AI evaluation requiring expert-established ground truth from clinical images or patient data. The "ground truth" here is compliance with engineering specifications, material standards, and regulatory guidelines, verified by laboratory measurements.

4. Adjudication Method for the Test Set:

• N/A. This concept applies to human reader studies or AI performance evaluations, not to the bench and material testing performed for this device. Test results are objective measurements against pre-defined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. As explicitly stated in the summary, "N/A - Clinical evidence was not necessary to show substantial equivalence." An MRMC study is a type of clinical study used for diagnostic devices, particularly those involving image interpretation by human readers.

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

• No. This device is a physical tracheostomy tube, not a software algorithm.

7. The Type of Ground Truth Used:

• For this device, the "ground truth" is defined by engineering specifications, international consensus standards (e.g., ISO 10993, ISO 11135, ISO 11607, ISO 5366, ISO 5356), and FDA guidance documents. Compliance with these established objective criteria serves as the basis for performance evaluation and substantial equivalence determination.

8. The Sample Size for the Training Set:

• N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. As no training set for an AI model was used, this question is not applicable.

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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.

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