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The Kimberly-Clark* MICROCUFF Pediatric Endotracheal Tubes are designed for oral / nasal intubation and are indicated for airway management.

The Kimberly-Clark* MICROCUFF Pediatric ET Tubes are available in sizes 3.0 to 4.5 in increments of 0.5 mm. They are available as Magill and pre-formed, made with an ultra thin polyurethane cuff, referred to as the MicroCuff.

This 510(k) summary describes a traditional medical device (tracheal tubes). It does not include information about artificial intelligence (AI) and therefore, does not provide the details required for some of your questions, particularly those related to AI model performance, training sets, and expert evaluations in the context of AI.

However, I can extract the available information regarding the device's acceptance criteria and the studies performed to demonstrate its equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "bench testing," "biocompatibility," "sterilization," and "functional test results" but does not specify the sample sizes used for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests and not clinical data sets.

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

This information is not provided in the document. The tests described are laboratory-based and do not involve "ground truth" derived from expert consensus in the way an AI model's performance on clinical images would.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. Adjudication methods are typically relevant for human-interpreted data, especially in clinical trials or AI model evaluations, where discrepancies between readers or outputs need resolution. The tests here are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an intervention (like AI assistance) on human reader performance, which is not applicable to a physical medical device like an endotracheal tube.

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. This device is a physical endotracheal tube, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by objective measurements and industry standards for tracheal tube function, biocompatibility, and sterility, as demonstrated through the bench, biocompatibility, sterilization, and functional tests. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical product, not an AI algorithm that requires a training set.

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

This information is not applicable. (See point 8).

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