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The intended use of this device is to permit conventional ventilation, suctioning, and spontaneous ventilation on the part of an adult patient after insertion of the device in an incision at the cricothyriod space.
The Tracheony Tube for Emergency Cricothyrotomy is intended for emergency surgical crioothyrotomy.

Polamedco's Tracheostomy Tube for Emergency Cricothyrotomy is designed for use by EMT's, Paramedics, E.R. Physicians, Anesthesiologists and R.N.'s. The length of the device is longer than a tracheostomy tube with comparable internal diameter/outside diameter. The device features a beveled smooth rounded tip that minimizes trauma. The device is made of flexible medical grade PVC. Features full radiopaque line for tube depth visualization. Packaged Sterile and single use. Latex Free. The device is made with heavy metal free materials that are safe incinerate and autoclave. Available in: 5.5 mm., 6.0 mm and 6.5 mm. ID sizes.

The provided text describes a medical device submission (510(k)) for a Tracheostomy Tube for Emergency Cricothyrotomy by Polamedco, Inc. However, it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the context of typical AI/software validation.

Instead, the document details physical/technical comparisons to a predicate device, regulatory classifications, and general performance summaries related to manufacturing and sterilization processes, which are standard for medical device approvals, not AI/software performance.

Therefore, many of the requested fields cannot be answered based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document describes a traditional medical device (tracheostomy tube), not an AI/software device. The "tests" mentioned are manufacturing and sterilization validation, not performance evaluation on a "test set" in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth in the context of expert review for diagnostic algorithm performance is not relevant to this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. This is a physical medical device.

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

• Not applicable / Different definition of "ground truth". For a physical device, "ground truth" would relate to meeting manufacturing specifications, material properties, and sterility standards through various engineering and chemical tests, rather than clinical consensus or outcomes data for diagnostic accuracy.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML model.

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

• Not applicable.

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