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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.

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.

Here's a breakdown of the acceptance criteria and study information for the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on the substantial equivalence of the device and does not explicitly list specific numerical acceptance criteria for clinical performance (e.g., target success rates, symptom improvement percentages). Instead, the performance data section describes meeting acceptance criteria for various bench tests related to device integrity and safety.

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

• Test Set (Clinical Data):
  • The document references "real-world clinical data collected from 25 patients from two sites."
  • Data Provenance: The document cites a publication by Luukkainen et al. (2017) regarding the feasibility of balloon Eustachian tuboplasty under local anesthesia. One of the authors, Rautiainen M, is from Finland (based on a quick search for the publication reference, not explicitly stated in the provided text). It's likely this smaller clinical data set is retrospective or a case series/pilot observational study, given the description as "real-world clinical data" supporting use under local/topical anesthetic. The document does not describe a formal, large-scale clinical trial used as a "test set" for the purpose of establishing primary effectiveness or safety endpoints in a randomized controlled manner.

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

• The document does not specify the number of experts used or their qualifications for establishing ground truth for the 25-patient clinical data set. The clinical data appears to be observational and intended to support the feasibility of the device under certain anesthetic conditions rather than being a formal "test set" with pre-defined ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set

• No adjudication method is described for the 25-patient clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided document. The device is a medical device for dilation, not an imaging or diagnostic AI tool where MRMC studies are typically performed.

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

• This question is not applicable. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a physical medical device, not an algorithm or AI system. Its performance is evaluated through bench testing, biocompatibility, sterilization, and then clinical use with human operators.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" for bench testing would be predefined engineering specifications, material properties, and regulatory standards (e.g., dimensional tolerances, burst pressure limits, sterilization efficacy, biocompatibility assay results).
• For Clinical Data (25 patients): The clinical data from the 25 patients likely relied on clinical endpoints, such as resolution of Eustachian tube dysfunction symptoms, patency of the Eustachian tube, or patient satisfaction, as assessed by the treating physicians. The document does not detail how "ground truth" was established for these clinical outcomes in this specific dataset.

8. The Sample Size for the Training Set

• This question is not applicable as the ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a physical medical device, not an AI model requiring a "training set" in the computational sense.
• The document mentions that the device has "expanded indications for use" and that "additional clinical testing was not required to demonstrate safety and efficacy of the device" because it is substantially equivalent to predicate devices. This indicates that prior clinical data from the predicate devices and existing literature inform its use, rather than a new "training set" for an algorithm.

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

• This question is not applicable for the reasons stated in point 8.

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The ACCLARENT AERATM Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 22 and older.

The ACCLARENT® AERA™ Eustachian Tube Balloon Dilation System includes the Eustachian Tube Balloon Catheter (ETBC) and the Eustachian Tube Guide Catheter (ETGC). The system is provided with the following additional devices: the Acclarent SE Inflation Device (or Acclarent Balloon Inflation Device) and Relieva Extension Tubing. The Acclarent SE Inflation Device (or Acclarent Balloon Inflation Device) is used to inflate the ETBC. The Acclarent SE Inflation Device and Acclarent Balloon Inflation Device are FDA cleared devices (K150172 and K052198, respectively). The Relieva Extension Tubing may be used to connect the Balloon Catheters and the Inflation Device when additional tubing length is required. The Relieva Extension Tubing is a Class I exempt device under 21 CFR 874.4420. All devices are provided sterile for single-patient use.

The ETBC is a 6x16mm (inflated diameter x length) flexible Balloon Catheter (Figure 1) 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 (ET). The shaft consists of dual lumen tubing with an actuator component that is designed to assist in rotation and advancement of the ETBC. The balled catheter tip (aka, "blueberry tip") on the ETBC is designed to restrict advancement of the device into the bony portion of the ET, 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 ETGC (Figure 2) is designed to facilitate ETBC access to the ET. The ETGC incorporates an atraumatic distal tip and distal angled tip profile that facilitates access to the ET. The ETGC contains a lubricious inner liner to allow smooth passage for the ETBC and includes a hypotube for rigidity.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

ACCLARENT AERA™ EUSTACHIAN TUBE BALLOON DILATION SYSTEM

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various non-clinical/bench studies and a clinical study that demonstrate the device's performance against specific criteria.

Non-Clinical/Bench Studies Acceptance Criteria and Performance:

Cadaver Study Acceptance Criteria and Performance:

Clinical Study Acceptance Criteria and Performance:

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

The primary test set used for evaluating the device's efficacy and safety was the randomized cohort of the clinical study, supplemented by a "lead-in" group and cross-over subjects for safety.

• Sample Size (Clinical Study - efficacy primary analysis cohort):

  • Investigational Arm (ETBC + MM): 141 subjects
  • Control Arm (MM alone): 72 subjects
  • Total for efficacy primary analysis: 213 subjects
  • Total for safety analysis: 299 subjects (includes 80 lead-in + 149 randomized ETBC + 70 MM cross-overs)

• Data Provenance: The study was a prospective, multi-center, randomized controlled trial. The document does not explicitly state the country of origin, but "Acclarent, Inc." is located in Irvine, CA 92618 (USA), suggesting the study was likely conducted in the United States or internationally with US-based sponsorship.

• Sample Size (Cadaver Study): Not explicitly stated, but implies multiple cadaveric specimens and multiple ENT physicians. "Each evaluator used the same device to dilate a left and a right ET of the same specimen."

• Sample Size (Bench/Non-clinical Studies): The text does not provide specific sample sizes for these tests (e.g., number of balloons burst, catheters tested for tensile strength).

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

For the clinical study:

• Primary Efficacy Endpoint (Tympanogram Normalization):

  • Ground Truth Established by: Both the investigator and an independent evaluator with appropriate expertise.
  • Qualifications of Independent Evaluator: "appropriate expertise unaffiliated with study patient care." The specific professional title (e.g., otologist, audiologist) or years of experience are not provided, but the description implies clinical expertise in interpreting tympanograms.

• Secondary Efficacy Endpoint (ETDQ-7): This is a patient-reported outcome, so the "ground truth" is self-reported by the patient.

• Cadaver Study Ground Truth:

  • Experts: ENT physicians.
  • Qualifications: Not explicitly stated beyond "ENT physicians." The context implies they are experienced enough to evaluate device performance in a cadaveric model.

4. Adjudication Method for the Test Set

For the clinical study's primary endpoint (tympanogram normalization):

• Adjudication Method: It was graded by both the investigator and an independent evaluator. The independent evaluator was blinded to the subjects' arm assignment and investigators' tympanogram results. The text does not explicitly state how disagreements between the investigator and the independent evaluator were resolved (e.g., if a third party was consulted or if the independent evaluator's assessment was considered definitive in cases of discrepancy). However, the blinding of the independent evaluator suggests their assessment held significant weight in establishing "ground truth."

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

• No MRMC comparative effectiveness study was done in the form of comparing human readers with and without AI assistance, as this is a medical device (balloon dilation system), not an AI diagnostic tool.
• Instead, a Multi-Center Randomized Controlled Trial was conducted comparing patients treated with the device (ETBC + Medical Management) to a control group (Medical Management alone).
• Effect size of human readers improve with AI vs. without AI assistance: Not applicable.

6. Standalone Performance

• Yes, a standalone performance was done for the device itself through the non-clinical and bench testing. These tests evaluated the device's physical properties, material compatibility, sterility, and functional performance (e.g., balloon burst pressure, deflation time, tensile strength, fatigue) without human interaction (beyond operating the test equipment).
• The cadaver study also evaluated the device's functional performance in a simulated use environment, but this involved human operators (ENT physicians).
• The clinical study evaluated the device's performance in a human-in-the-loop scenario, where the device was used by physicians on patients.

7. Type of Ground Truth Used

• Clinical Study (Primary Efficacy):
  • Expert Consensus/Interpretation: Tympanogram normalization was assessed by both the treating investigator and an independent, blinded expert evaluator. This indicates a form of expert consensus or adjudicated expert assessment.
• Clinical Study (Secondary Efficacy):
  • Patient-Reported Outcomes: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7) scores are directly reported by patients.
• Cadaver Study:
  • Expert Observational Assessment: ENT physicians evaluated device performance parameters (e.g., placement, trauma avoidance, functionality) through direct observation and experience.
• Bench/Non-Clinical Studies:
  • Physical Measurement/Quantitative Testing: Based on objective measurements against pre-defined engineering specifications (e.g., tensile strength, burst pressure, dimensions).

8. Sample Size for the Training Set

• For the clinical study, there was no separate "training set" in the context of an algorithm training. However, there was a Lead-In phase for the clinical study where investigators performed procedures before randomization started, which served as a form of "training" or experience-building for the clinicians with the device.
  • Lead-In Subjects: 81 subjects.
• For the cadaver study, the evaluation itself served as a "training" for the physicians on device use, but there isn't a "training set" in the machine learning sense. The physicians were trained.
  • Training (for users): Mentioned in "Special Controls." "Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device."

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

• Clinical Study (Lead-In phase): The "ground truth" for the Lead-in subjects would be the clinical outcomes experienced by those patients. There's no indication of a separate ground truth establishment method for this group distinct from the randomized cohort. Their purpose was primarily for investigator experience and procedural refinement.
• Cadaver Study (Physician Training): The "ground truth" for the simulated use in cadavers was established by a pre-defined 1-4 point rating scale for various attributes, with "2" or higher being "clinically acceptable." This was based on the expert judgment of the evaluating ENT physicians against pre-established criteria.

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