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The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

The Cook Ciaglia percutaneous tracheostomy devices are designed for percutaneous dilational tracheostomy for management of the airway. More specifically, the devices allow for two approaches to the dilation of the stoma: serial dilation (Ciaglia Percutaneous Tracheostomy Introducer Set) or single-stage dilation (Blue Rhino® and Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set). Serial dilation is achieved using numerous progressively larger dilators. Single-stage dilation is achieved with a single rhino-horn-shaped dilator using an in-and-out motion. The Cook Ciaglia percutaneous tracheostomy devices are sold sterile for single use. There are multiple configurations that include various set and tray components (Table 1) associated with the procedure and/or in gaining percutaneous access.

The provided document describes the Cook Ciaglia percutaneous tracheostomy devices and their substantial equivalence to a predicate device, K041348: Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit. The submission focuses on non-clinical testing and a summary of existing clinical literature rather than a new standalone clinical study for this 510(k) submission.

Here's the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests with associated acceptance criteria, but it primarily states that the test article met the predetermined acceptance criteria or was greater than/less than or equal to the acceptance criterion/predicate. Specific numerical acceptance criteria or performance metrics are not explicitly detailed in the tables or text.

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

The document does not specify the sample sizes (n) used for each individual non-clinical test mentioned (e.g., tensile, compression, fracture). The data provenance for these non-clinical tests is "in-house" by Cook Incorporated.

For the summary of clinical performance, which involved an evaluation of published clinical evidence:

• Test Set (Clinical Evidence Review):
  • Cook devices: 24 articles incorporating 8,726 patients.
  • Predicate device (Portex Ultraperc): 4 articles incorporating 1,036 patients.
• Data Provenance: Retrospective literature review of published clinical evidence. The specific countries of origin for the studies included in this review are not mentioned.

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

N/A for the non-clinical tests, as ground truth is based on engineering specifications and direct measurement.

For the clinical evidence review, there is no mention of external experts establishing ground truth for the summarized papers. The review itself constitutes an assessment by the applicant, Cook Incorporated.

4. Adjudication Method for the Test Set

N/A for non-clinical testing. For the clinical evidence review, no specific adjudication method for the included articles is described; it appears to be a summary of findings rather than a formal adjudication process.

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

No. The document explicitly states: "Clinical tests were not required to demonstrate substantial equivalence of the Cook Ciaglia percutaneous tracheostomy devices as compared to the predicate devices." Instead, a summation of existing clinical literature was performed. Therefore, an MRMC comparative effectiveness study was not conducted as part of this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a medical device (tracheostomy introducer set), not an AI algorithm. The performance evaluation is based on the physical properties and function of the device itself and its components.

7. The Type of Ground Truth Used

• Non-Clinical Testing: Engineering specifications, design requirements, and direct physical measurements (e.g., load, force, kinking absence, fit). For some tests (e.g., 3 Point Bend, Insertion Force), the predicate device's performance also served as a comparative "ground truth" or benchmark.
• Summary of Clinical Performance: Published clinical evidence (peer-reviewed articles) on the safety and effectiveness of the subject and predicate devices, which would have their own established ground truths (e.g., clinical outcomes, complication rates from patient data).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device. There is no "training set" in the context of this device submission.

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

N/A. Not applicable as there is no training set for an AI/ML device.

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