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The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.

For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.

The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes a Eustachian Tube Balloon Catheter and Guide Catheter designed specifically for use in accessing and dilating the Eustachian Tube. The system is used with the following additional devices: the Acclarent® SE Inflation Device (or Acclarent® Balloon Inflation Device). The Acclarent® SE Inflation Device or Acclarent® Balloon Inflation Device is used to inflate the balloon. All devices are provided sterile for single-patient use. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes is a 6x16mm (inflated diameter x length) flexible Balloon Catheter with an integrated shaft and a nylon balloon at the distal tip. The non-compliant balloon is designed to dilate the cartilaginous portion of the Eustachian tube. The shaft consists of dual lumen tubing with an actuator component that is designed to assist in rotation and advancement of the balloon catheter. The balled catheter tip (aka, “blueberry tip") on the balloon catheter is designed to restrict advancement of the device into the bony portion of the Eustachian tube, known as the isthmus. There is an endoscopic marker placed at the proximal taper of the balloon to aid in positioning under direct endoscopic visualization. The AERA Guide Catheter is anatomically designed to facilitate AERA Balloon Catheter access to the Eustachian tube. The AERA Guide Catheter incorporates an atraumatic distal tip and distal angled tip profile that facilitates access to the Eustachian tube. The Guide Catheter supplied with the ACCLARENT AERA® Eustachian Tube Balloon Dilation System contains a lubricious inner liner to allow smooth passage for the balloon catheter and includes a hypotube for rigidity.

The Acclarent AERA Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for the treatment of persistent Eustachian tube dysfunction. The expanded indication covers patients aged 8-17 years with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and refractory to at least one surgical intervention.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set (for pediatric expansion):

  • Clinical Data: Efficacy data was reported from 20 ears of patients aged 8-17 years with Chronic Otitis Media with Effusion. Safety data encompassed a broader analysis across the expanded pediatric age group (8-17 years), without a specific patient count provided for the 8.2% minor AE rate, but it was derived from real-world evidence.
  • Anatomical Equivalence: "Several articles" based on CT scan reviews were used. No specific number of patients or scans are provided for this.
  • Provenance: "Real-world evidence, with data from published literature and data provided by established physicians" was analyzed. It is retrospective in nature, as it relies on existing published literature and real-world clinical experience. The country of origin of the data is not specified but is generally understood to be diverse given the nature of a systematic literature review and physician-provided data.

• Training Set: The document does not explicitly describe a separate "training set" in the context of an AI/ML algorithm requiring such a set. The performance data for the device (mechanical, biocompatibility, sterilization, etc.) relies on previously submitted bench testing and validations, which are not typically referred to as training sets. The clinical data for the pediatric expansion relies on real-world evidence and a systematic literature review, which also does not fit the typical definition of a training set for an AI/ML model.

3. Number of Experts and Qualifications for Ground Truth:

• For Clinical Data (Pediatric Expansion): The document mentions "data provided by established physicians." It does not specify the number or specific qualifications (e.g., years of experience) of these individual physicians, nor does it detail the experts involved in conducting the systematic literature review.
• For Anatomical Equivalence: Similarly, the CT scan reviews were used as evidence for anatomical equivalence, based on "several articles." The experts performing these CT scan reviews or evaluating the articles are not explicitly identified or qualified.

4. Adjudication Method for the Test Set:

• The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical data or anatomical equivalence evaluations for the pediatric expansion. The data from published literature and physician-provided data likely reflect outcomes as recorded and reported in their respective studies or practices.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a physical medical device for dilation, not an AI or imaging diagnostic software that would typically involve human readers interpreting cases with and without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone (algorithm only) performance study was not done. As noted above, this device is a physical medical device (balloon dilation system), not a software algorithm that would have standalone performance.

7. Type of Ground Truth Used:

• For the pediatric efficacy data, the ground truth was based on:
  • Clinical Outcomes/Measurements: Improvement in tympanometry (an objective measure of middle ear function).
  • Failure-Free Rate: Defined as not requiring further surgery for ETD (e.g., tympanostomy tube insertion or revision ETBD), which is an outcome-based measure.
• For the pediatric safety data, the ground truth was based on:
  • Reported Adverse Events: Classification of events as serious or minor, as observed in real-world clinical practice and literature.
• For anatomical equivalence, the ground truth was based on:
  • CT Scan Reviews: Morphometric analysis of Eustachian tube anatomy as reported in published studies.

8. Sample Size for the Training Set:

• As mentioned in section 2, the document does not describe a "training set" in the context of AI/ML. All referred performance data are either previously established bench tests for the device itself or real-world clinical evidence/literature reviews for the expanded indication.

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

• Not applicable, as a conventional "training set" with established ground truth for an AI/ML model is not described in this submission. The "ground truth" for the device's functional and safety characteristics was established through standard engineering bench testing and clinical data collection/review methodologies relevant to medical devices.

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