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The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.

The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, and the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set consist of an airway catheter, a loading dilator, a wire guide, a catheter needle, and an introducer needle. In addition to these components, standard preparation components, such as a syringe, scalpel, dilator forceps, gauze, drape, tracheostomy tape, and tracheal hook are included. The sets consist of any combination of components appropriate for either percutaneous or surgical placement of a cricothyrotomy tube, or both.

The curved cricothyrotomy catheter is manufactured as a 22 French catheter with a length of 9 centimeters and an inner diameter of 5 millimeters. The loading dilators are either 11 centimeters or 12 centimeters long. The stainless steel wire guide has a 0.038-inch diameter and a length of 40 centimeters. The catheter needle is a two-part needle comprised of a small hubbed catheter sheath covering a hubbed needle. The sheath of the catheter needle is manufactured from fluorinated ethylene propylene tubing. The catheter needle is manufactured using an 18 gage cannula with a length of 7 centimeters. The introducer needle is also manufactured from 18 gage stainless steel and has a length of either 5 centimeters or 7 centimeters.

The provided document describes a 510(k) premarket notification for the Melker Cuffed Emergency Cricothyrotomy Catheter Set and its variations. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information provided relates to design validation and performance testing to ensure the device is as safe and effective as its predicate, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

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

The document does not specify the sample sizes (number of units tested) for any of these engineering or material tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective nature, as these are in vitro or in silico material and mechanical property tests, not human clinical studies.

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

This information is not applicable to the types of tests described. These are objective engineering and material property tests, not based on expert interpretation of data.

4. Adjudication method for the test set:

This information is not applicable. The tests described have objective pass/fail criteria based on physical measurements.

5. 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 device is a medical instrument (catheter set), not an AI diagnostic or assistance tool. The submission is for a 510(k) premarket notification, which focuses on substantial equivalence based on technical characteristics and performance, not on demonstrating clinical improvement through reader studies.

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

No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for these tests is based on engineering standards and physical properties. For example:

• Durability and Tensile Strength: Ground truth is the physical integrity and mechanical strength of the materials as measured against quantitative thresholds (e.g., "minimum force at break of 15 N").
• MRI Compatibility: Ground truth is established by meeting specific ASTM standards (F2052, F2213, F2119) for magnetically induced forces, torque, and image artifact.
• Radiofrequency Heating: Ground truth is based on the measured electrical conductivity compared to a specified limit (< 1 S/m).

8. The sample size for the training set:

This information is not applicable, as this is not an AI/machine learning device that requires a training set.

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

This information is not applicable, as this is not an AI/machine learning device.

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