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The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnoutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the NGB Balloon System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.

The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.

The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.

The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.

The Next Generation Balloon Dilation System (NGB) is an integrated balloon sinuplasty (BSP) and Eustachian tube (ET) dilation device, that will be available in light fiber and navigation guidewire configurations for compatibility with illumination and navigation technology. The system includes a handle with several integrated features to allow for single-handed use. The adjustable gripping feature allows for ergonomic handling. The directable guide tip enables access (i.e. manipulating/separating/dividing tissue) and placement near the targeted anatomy. There are four preset approximate positions: Sphenoid (straight), Eustachian tube (55°), Frontal (70°), Maxillary (110°). The directable guide knob allows for positioning of the balloon tip towards the target anatomy. The wire slider and spinner are used to advance, retract, and rotate the guidewire. The balloon slider is used advance and retract the balloon. The Next Generation Balloon Dilation System also allows for suction and irrigation in and around the target anatomy.

Here's a breakdown of the acceptance criteria and the study information for the Acclarent Next Generation Balloon Dilation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, rather than specific acceptance criteria in terms of performance metrics with pre-defined thresholds, the document outlines the types of non-clinical tests performed and states that the device "met all acceptance criteria" and "passed all tests in accordance with appropriate test criteria and standards."

2. Sample Size for Test Set and Data Provenance

The document explicitly states: "Clinical data was not necessary to determine that the subject Next Generation Balloon Dilation System performs as intended." This indicates that no clinical "test set" was used as part of this submission for performance evaluation against specific clinical acceptance criteria. The performance data is derived solely from non-clinical bench testing. The provenance of this data is therefore internal laboratory testing rather than patient data from a specific country or retrospective/prospective study.

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

Not applicable, as no clinical test set was used to establish ground truth with expert review.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission is based on demonstrating substantial equivalence through non-clinical testing.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device, not an algorithm, and its performance is evaluated in relation to its physical and functional characteristics.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be the engineering specifications, industry standards (e.g., AAMI/ANSI/ISO for sterilization, ASTM for shelf life), and validated internal test methods that define acceptable performance.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device effectively comes from its design and manufacturing processes, guided by engineering principles and regulatory standards.

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

Not applicable, as no training set was used.

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