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The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is intended for controlled elective subcricoid insertion of a tracheostomy tube.

The Ciaglia Cheetah™ Percutaneous Tracheostomy Introducer Set is intended for controlled elective subcricoid insertion of a tracheostomy tube.

The Ciaglia Blue Dolphin™ Balloon Percutancous Tracheostomy Introducer consists of an inflatable balloon on a double lumen 5 Fr inner coaxial catheter shaft; the loading section of the milalable Danbon on a double fullien 9 1 1 11.12 106. 27 and 28 French sizes. The length of the catheter shaft is 21.5 cm with a Luer port for inflation and a Luer port for the wire guide. The calleter shall is 21,5 on with a rated burst pressure of 6 atm. The set components include the balloon catheter, catheter access needle, 0.035" wire guide, dilator, 20 cc controlled syringe and balloon catherer, battleter doods insertion. The set is supplied sterile and intended for one-time use.

The provided text is a 510(k) Summary for a medical device called the "Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer" (which is later referred to as "Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set" in the FDA letter). It details the device's intended use, substantial equivalence to predicate devices, and a brief description. However, this document only lists the types of tests performed and does not provide detailed acceptance criteria or study results that prove the device meets specific performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text.

Based on the information provided, here's what can be extracted regarding testing:

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

• Cannot be provided as the document only lists types of tests without specific criteria or results. The text states:

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

• Not specified in the provided text. The document refers to "Test Data" but does not detail the methodology, sample sizes, or data provenance.

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

• Not applicable/Not specified. The testing mentioned appears to be bench testing (biocompatibility, tensile strength, etc.) rather than clinical studies requiring expert ground truth establishment.

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

• Not applicable/Not specified. This pertains to clinical studies involving human readers or expert review, which is not described in the context of the listed tests.

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 physical medical introducer, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm. The testing described appears to be for the physical characteristics and safety of the device itself.

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

• Not applicable/Not specified. The "ground truth" for the engineering and biocompatibility tests would be established by validated test methods and reference standards, but this is implied rather than explicitly detailed. For example, for "burst pressure," the ground truth would be the actual pressure at which the balloon bursts, measured against a specified limit.

8. The sample size for the training set

• Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device. The document describes pre-market testing of a physical device.

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

• Not applicable. As there is no training set mentioned, there is no ground truth, as defined in an AI/ML context, for it.

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