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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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Model 301: device is intended for providing tracheal access for airway management including artificial ventilation.

Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to sately wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve".
Model 303: device is intended for providing tracheal access for airway management.

Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve".
Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy.

Model 401: device is intended for use in patients with the larynx intact in combination with TRACOES-FLEX model 302 and 304.

The TRACOE -FLEX tracheostomy tubes, the accessories as well as the replacement parts (inner cannulas and plugs) are sterile products for single patient use only. They essentially consist of a neck plate, an outer and an inner cannula. Outer and inner cannulas consists of thin walled relatively soft plastic material, which gets even softer at body temperature. The special feature of the TRACOE -FLEX tracheostomy tubes is, that the neck flange is movable in a horizontal as well as in a vertical axis, so that the cannula inside the trachea does not move, when the patient either bends or turns his head. The outer cannula can carry an inflatable low pressure high volume cuff (models 301 and 302) and/or can be perforated (models 302 and 304). Inner cannulas with a twist-lock 15 mm adapter are non fenestrated (models 301, 302, 303 and 304); additional inner cannulas with a short blue twist-lock adapter (models 302 and 304) are fenestrated. Fenestrated inner cannulas with an integrated "speaking valve" for models 302 and 304 are available as accessories (model 401) for all sizes.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of typical AI/ML medical device submissions. Instead, it describes a traditional medical device (tracheostomy tubes) and its comparison to predicate devices for 510(K) clearance.

Therefore, I cannot fulfill your request for the following sections:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

However, I can provide information based on the "Assessment of Substantial Equivalence based on non-clinical Performance Data" section:

Summary of Device Performance and Equivalence

The TRACOE®-FLEX tracheostomy tubes, including the "speaking valves," were tested in comparison to Shiley/Mallinckrodt tubes. The assessment aimed to demonstrate substantial equivalence, focusing on physical characteristics and performance rather than a clinical study with patients or AI-driven analysis.

Non-Clinical Performance Data Overview:

• Tests Conducted: Measurements of dimensions, resistance to airflow, kink resistance, and connection between cannula and neck plate.
• Results: All tested parameters were "at least as good as those of the predicate devices." Some features showed improvement, specifically:
  • Resistance to airflow
  • Softness of the wall
  • Flexibility between cannula and neck plate

Key Technological Characteristics and Improvements (compared to predicate devices):

• Neck Plate Flexibility: TRACOE®-FLEX tubes have a neck plate that allows movement in both horizontal and vertical axes, enhancing cannula stability during patient head movements, unlike Shiley/Mallinckrodt tubes which only move horizontally, and other tubes with fixed neck plates.
• Thinner Cannulas: TRACOE®-FLEX tubes have thinner cannulas, which at a given tracheostoma size, provide comparatively higher airflow.
• Softer Material: Made from a softer plastic (polyurethane) than Shiley products, resulting in greater softness and flexibility.
• Integrated Speaking Valve: The Tracoe "speaking valves" are constructed as an integral part of the inner cannulas, making them less bulky than predicate devices from Shiley/Mallinckrodt and Passy-Muir.

Biocompatibility Assessment:

• All materials are medical grade with certificates of compliance.
• Elution tests according to USP23 on final sterilized products were negative.

This information describes the evidence provided for a traditional medical device's 510(k) submission, confirming its equivalence to existing devices based on non-clinical performance and material biocompatibility. It does not fit the structure of an AI/ML device study.

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