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Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.

The VITALTEC Rota-Trach Tracheostomy Tubes are made from the raw material of The VITALIEC Kota Track Track Tracksonsyland of connector and valve. The the seeff with Sincolle for medical ass, while the components of the propriate hardness, the cuff with tubes have such good perfectionsment tube and excellent biocompatibility.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VITALTEC Rota-Trach Tracheostomy Tube:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. For such submissions, the primary "study" is often a comparison to the predicate device and adherence to recognized standards, rather than a separate clinical trial with specific performance metrics like sensitivity/specificity for diagnostic AI.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics commonly seen in diagnostic device studies (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with relevant international standards.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of a typical algorithm or AI study. The evaluation is based on non-clinical data (bench testing, material testing, and standards conformance).

• Sample Size for Test Set: Not applicable in the context of an AI study. The evaluation relies on testing of the device itself for compliance with standards and comparison specifications.
• Data Provenance: Not applicable. The "data" are results from physical and biological tests conducted on the device, as well as its specifications. The manufacturer is VITALTEC CORPORATION in Taiwan, ROC.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This is not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a medical device (tracheostomy tube), not a diagnostic algorithm where human readers would be assessing performance with or without AI assistance.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm. The "standalone" evaluation refers to the device's conformance to standards and its specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established by:

• International Standards: ISO 5356-1 (connector dimensions), ISO 10993 series (biological evaluation), ISO 17665-1 (sterilization).
• Predicate Device Specifications: The established and accepted performance and design of the previously cleared "Medical Tracheostomy Tubes (K031553)."
• Physical and Biological Test Results: Data from tests demonstrating biocompatibility, sterility, and mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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