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The TubaVent balloon dilatation system is intended to dilate the cartilaginous portion of the Eustachian tube for treatment of persistent obstructive Eustachian tube dysfunction in patients 18 years and older.

The TubaVent balloon dilatation system is an Eustachian Tube Balloon Dilatation System consisting of the balloon catheter, the Tubalnsert insertion device and the inflation device. It is used for dilation of the cartilaginous portion of the Eustachian tube in persistent obstructive Eustachian tube dysfunction. The balloon catheter TubaVent is available in two versions where the balloon diameter is different: 3 and 4.5 mm. The insertion device Tubalnsert has an angle of 45° at the distal end.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the TubaVent Balloon Dilatation System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details performance tests that were conducted and states that the device "met all acceptance criteria." However, it does not provide a specific table outlining the acceptance criteria values themselves (e.g., "burst pressure > X bar") alongside the measured performance. Instead, it describes the types of tests performed and a general statement of compliance.

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

• Human Cadaver Study (Design Validation): The text mentions a "human cadaver study" was executed for design validation and to fulfill a special control requirement (874.4180(b)(iv)(6)). It does not specify the sample size (number of cadavers or Eustachian tubes tested) or the provenance (country of origin, retrospective/prospective).
• Simulation Studies: Acknowledges "simulation studies in a head model and in an animal cadaver model (sheep head)" but does not specify sample sizes for these.
• Human Factors Validation Testing: No sample size or details about the participants are provided.

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

The document does not describe the establishment of a "ground truth" for a test set in the context of expert consensus, pathology, or outcomes data. The studies mentioned (biocompatibility, performance, shelf life, human cadaver, human factors) are primarily engineering and safety evaluations rather than diagnostic accuracy or clinical effectiveness studies requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the clinical study type requiring such adjudication (e.g., diagnostic accuracy where experts review cases) was not performed or detailed.

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 instrument (balloon dilatation system), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document primarily relies on engineering specifications, biological safety testing (biocompatibility), and functional performance data. For the human cadaver study, the "ground truth" would likely be the physical integrity and proper function of the device within the anatomical context, assessed through direct observation and measurements, rather than an expert consensus on a pathological finding or clinical outcome.

8. The Sample Size for the Training Set

Not applicable, as this device does not involve machine learning or AI models with training sets.

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

Not applicable, as this device does not involve machine learning or AI models with training sets.

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