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As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system isolates the flora from the patient's secretions, thus reducing the risk of cross-contamination to health care providers and other patients.

5 French through 18 French TRACH CARE® Closed Suction Endotracheal Suction Catheters with MICROBAN® and various airway connectors.

This device, the TRACH CARE® with MICROBAN®, is an Endotracheal Suction Catheter. The 510(k) summary indicates that the submission requests permission to market a device with a label change, extending the recommended use time from "24 hours" to "72 hours."

The submission explicitly states: "The device of this submission is identical in design, material, chemical composition, and all other logical characteristics as the predicate device. This submission requests permission to market a device with a label change in contraindications FROM "Do not use for more than 24 hours." TO "Do not use for more than 72 hours. Change more frequently if catheter becomes soiled or develops any other factor which reduces device efficiency.""

This implies that the acceptance criteria and study proving the device meets them are based on demonstrating that the device remains safe and effective for the extended 72-hour use period, given that its physical characteristics are otherwise identical to the previously cleared 24-hour version. However, the provided text does not contain any specific performance data, acceptance criteria, or details of a study that directly prove the device meets these extended use criteria for the 72-hour period. The clearance is based on the substantial equivalence argument of the label change.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be inferred or stated based on the available information:

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 provided. The document does not describe any specific test set or study conducted for the 72-hour extended use claim.

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 / Not provided. Since no specific test set or study is described, this information is not available.

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

• Not applicable / Not provided.

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 device is a medical device (endotracheal suction catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.

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

• Not applicable. This is not an algorithmic device.

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

• Not provided. The basis for extending the use time to 72 hours is not detailed in terms of specific ground truth data or studies. The substantial equivalence argument relies on the physical identity to the predicate.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable / Not provided.

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