(216 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | |
| Dimensional Attributes | Met all acceptance criteria |
| Cycle Fatigue | Met all acceptance criteria |
| Balloon Burst | Met all acceptance criteria |
| Bond Separation | Met all acceptance criteria |
| Biocompatibility | Testing has shown the device is biocompatible |
| Sterilization | Validated per AAMI/ANSI/ISO 11135:2014, achieving a sterility assurance level of 10^-6 |
| Ethylene Oxide Residuals | Met ISO 10993-7:2008 requirements |
| Packaging Shelf Life | Established at one year via accelerated aging per ASTM F1980-07 |
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.
§ 874.4180 Eustachian tube balloon dilation system.
(a)
Identification. A Eustachian tube balloon dilation system is a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Mechanical testing, including tensile and flexural testing of catheter joints and materials.
(ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components.
(iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon.
(iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms.
(2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life.
(6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device.
(7) Labeling must include:
(i) Detailed instructions for use.
(ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes.
(iii) A shelf life.