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The Rusch TracFlex Plus Tracheostomy Tube Set is used in airway management of tracheostomized patients

The Rusch TracFlex Plus Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 7-11mm in 1 mm increments, with accessories which may be included in a set or sold separately. The device is used to provide an artificial airway, in order to provide access to the patient's airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = < 0.1% DEHP w/w), and is stainless steel spiral armored. It is available cuffed and uncuffed. Accessories included in the set are a disposable inner cannula, obturator, shower cap, cough cap and sealing cap. The tracheostomy tube is secured using the flange that is connected to the neck strap.

The provided text describes a 510(k) premarket notification for a medical device, the Rusch TracFlex Plus Tracheostomy Tube Set. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting a full clinical study to prove efficacy and safety from scratch.

Therefore, the "study that proves the device meets the acceptance criteria" is primarily a non-clinical comparative performance testing study, designed to show that the new device performs equivalently to the predicate device. This is not a human clinical trial with outcomes data or a statistical analysis of diagnostic accuracy.

Here's an analysis based on your request, highlighting the differences in a 510(k) submission:

Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are established by engineering and performance standards (like ISO standards) and internal requirements to ensure the device performs comparably to the predicate and safely. The "reported device performance" indicates that the new device met these criteria.

Study Details (as applicable to a 510(k) non-clinical comparison)

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes (e.g., number of tubes, cuffs, or inner cannulas) used for each individual non-clinical performance test.
   • Data Provenance: The tests are described as "Non-clinical Comparative Performance Testing," implying they were conducted in a laboratory setting by the manufacturer (Teleflex Medical) as part of their regulatory submission process. No country of origin for data generation is explicitly stated, but the applicant is from the USA. These tests are inherently prospective in nature, as they are performed specifically to support the premarket notification.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this 510(k) submission. "Ground truth" established by human experts is typically relevant for studies involving diagnostic accuracy of an AI algorithm based on interpretation of medical images or clinical data.
   • For this device, the "truth" for non-clinical tests is determined by physical measurements, material properties, and mechanical performance against established engineering specifications and international standards (like ISO). The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting and interpreting the tests.

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, especially in studies where subjective interpretation or consensus is required to establish a ground truth (e.g., grading lesions in a medical image). Non-clinical performance tests involve objective measurements and pass/fail criteria against predefined standards.

4. 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, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating the impact of AI on human diagnosticians or interpreters, typically in imaging or clinical decision support. The Rusch TracFlex Plus is a physical medical device (tracheostomy tube), not an AI diagnostic tool.

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

   • No, a standalone algorithm performance study was not done. This device is a physical product, not a software algorithm.

6. The type of ground truth used:

   • For the non-clinical performance tests, the "ground truth" is defined by international standards (e.g., ISO 5366-1, ISO 5361, ISO 10993-1, ISO 10993-17, ISO 10993-18) and internal engineering specifications/drawings. These standards and specifications define the expected physical, mechanical, and biological properties of the device for safe and effective use.

7. The sample size for the training set:

   • This is not applicable. "Training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reason as above.

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