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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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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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The VenSure™ Balloon Dilation System is used to access and treat the frontal ostia/recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian in adult patients using a transnasal approach.
The VenSure™ Nav Balloon Dilation System is additionally intended for use in conjunction with the Cube Navigation System during ENT procedures when surgical navigation or image-guided surgery may be necessary to locate the Eustachian tube or to locate tissue, bone or cartilaginous tissue surrounding the drainage of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The VenSure™ Light Balloon Dilation System is additionally used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.

The VenSure Balloon Dilation Systems combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the Frontal, Maxillary, Sphenoid sinuses, and Eustachian tube using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and the Eustachian tube within the same patient. The devices come in an EO sterilized tray sealed inside of a Tyvek pouch with the bending tool, inflation device, and extension line included in the trav.
All VenSure versions enable a physician to track the device into the sinuses and eustachian tube using endoscopic visualization.
The VenSure™ Nav allows additionally for image-guided visualization when connected to the Cube Navigation System (manufactured by Fiagon). The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "blug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflation device to expand the outflow track of the targeted structure.
The VenSure™ Light additionally allows for LED light confirmation of the VenSure balloon through transillumination across nasal and sinus structures. The VenSure™ Light has an integrated flexible light fiber with battery powered LED light source designed to emit red light from the distal end of the VenSure balloon.
The VenSure™ ET is a 45°- pre-bent configuration of the basic VenSure (with straight balloon tip). The pre-bend to 45°bemt of the VenSure ET facilitates the use of the device when only used for treatment in the eustachian tube. The device however can also be reshaped to fit to the sinuses using the Bending tool.

The provided text describes the VenSure™ Balloon Dilation System, including the VenSure™ Light, VenSure™ Nav, and VenSure™ ET variants. These devices are used for balloon dilation of frontal ostial recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula, and the Eustachian tube in adults.

Here's an analysis of the acceptance criteria and the study information as requested:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Bench testing" and "Simulated use testing in clinical model." However, it does not specify sample sizes for the test sets used in performance data. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The reference to "clinical model" suggests a simulated environment rather than actual patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The studies described are primarily bench testing and simulated use, not those requiring expert interpretation of medical images or patient outcomes for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as the described studies do not involve expert adjudication of results in a clinical context.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device in question is a physical medical device (balloon dilation system) and not an AI/software product requiring human reader performance studies.

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

This refers to an AI/software device. The VenSure™ Balloon Dilation System is a physical medical device. While the VenSure™ Nav includes "image-guided visualization" and "navigation software," the document does not describe "standalone" algorithm-only performance in the context of an FDA-cleared AI/software device. The navigation functionality is an aid for the physician using the physical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the bench testing, the "ground truth" implicitly refers to engineering specifications and established physical properties (e.g., "dimensions of the balloon are as specified," "burst pressure at end of lifetime is above the rated in use pressure"). For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-1:2018). For sterilization, the ground truth is sterilization validation standards (ISO 11135-1). For navigation compatibility, it's about functionality and compatibility with the Fiagon Navigation system meeting accuracy ratings of the predicate. This is based on objective, measurable physical and engineering endpoints rather than clinical ground truth (like pathology or expert consensus on a diagnosis).

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI/machine learning model that typically requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/not provided as there is no mention of a training set for an AI/machine learning model.

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To dilate the cartilaginous portion of the Eustachian tube for treating tube dysfunction in patients 18 years and older using a transnasal approach.

The Audion ET dilation system (ET is an abbreviation for Eustachian tube) is intended to dilate the Eustachian tube through use of balloon dilation and a transnasal approach. It contains a dilation device, inflation device and inflation lock. The dilation device has a 1.26 mm outer diameter (OD) curved non-malleable shaft with a balloon fixed at the distal end and a 1.91 mm atraumatic polymer ball tip. The dilation device is positioned under endoscopic visualization with the balloon fully retracted. Once the portion of the device from the ball tip to the base of the curve is seated in the Eustachian tube, the balloon is advanced and then inflated. The deployed balloon angle of the dilation device is 45° for optimal treatment of the Eustachian tubes. The distal leg length with balloon extended is 18.5 mm. When the balloon is inflated to 12 atm, the balloon diameter is 6mm and the body length is 20 mm.

The inflation device is an accessory that consists of an inflation syringe and an extension line. The inflation device is designed to deliver a pressure of 12 atm and is used to inflate the balloon on the dilation device.

The inflation lock is an optional accessory that is intended to interface with the Audion dilation device, inflation syringe and extension line connections to hold or release pressure during balloon dilation.

The Audion ET dilation system is provided sterile and is for single patient use only. The dilation device, inflation device and inflation lock are sterilized using ethylene oxide.

The Audion ET dilation system has been tested to withstand multiple inflations in a surgical case

The provided text is a 510(k) summary for the Audion ET dilation system, a medical device for dilating the Eustachian tube. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on diagnostic performance (like an AI/imaging device).

Therefore, many of the requested categories (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they pertain to studies typically performed for AI or diagnostic imaging devices to prove efficacy/accuracy.

This document describes the device itself, its intended use, and its technological characteristics in comparison to a predicate device, along with bench testing to demonstrate performance as intended and meeting design specifications.

Here's what can be extracted and addressed:

1. A table of acceptance criteria and the reported device performance:

The document does not present acceptance criteria in a table format with corresponding quantitative performance metrics related to diagnostic accuracy or clinical outcomes. Instead, it states that "Performance testing showed that the device meets design specifications and performs as intended." The "acceptance criteria" here are implied to be the successful completion of various bench tests demonstrating the device's functionality, safety, and compatibility with its intended use, and substantial equivalence to the predicate.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of diagnostic data. The "test set" here refers to physical devices or components subjected to bench testing. The document does not specify the number of units tested for each specific bench test (e.g., how many devices were tested for strength, or how many packaging samples for integrity).
• Data Provenance: The tests are described as "bench testing" and "performance testing," which typically occur in a lab setting. There's no mention of country of origin for clinical data (as there was no clinical study described for efficacy) or whether it was retrospective or prospective. HFE/UE verification involved "ENT physicians."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified. The document mentions "ENT physicians" were involved in "HFE/UE verification testing" and "design validation." Their role seems to be evaluating the usability and design effectiveness, rather than establishing a "ground truth" for a diagnostic task.
• Qualifications of Experts: "ENT physicians." No further detail (e.g., years of experience, board certification) is provided.

4. Adjudication method for the test set:

Not applicable. There was no clinical study with a "ground truth" requiring adjudication. The document describes bench testing and usability verification, not multi-reader diagnostic interpretation.

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 is not an AI or diagnostic imaging device submission.

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

Not applicable. This is not an AI or diagnostic imaging device submission.

7. The type of ground truth used:

Not applicable in the context of diagnostic ground truth. The "ground truth" for this device's performance is its ability to meet engineering specifications (e.g., balloon diameter at a certain pressure, shaft strength, sterilization efficacy), which are verified through various physical and chemical tests.

8. The sample size for the training set:

Not applicable. There is no AI component requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. There is no AI component.

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The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297.

A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal.

Mounted near the distal end of the balloon handpiece is a flexible balloon section. Once the balloon section is advanced into the target Eustachian tube the 6mm diameter/16 mm long rigid balloon is inflated using the separate NuVent™ inflator, expanding the Eustachian tube canal tissue and cartilage.

The provided text is a 510(k) Summary for the NuVent Eustachian Tube Dilation Balloon. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. The information supplied in this document focuses on mechanical and functional performance testing to prove substantial equivalence, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes in the way a diagnostic AI device might be.

Therefore, many of the requested items (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance, training set details) are not applicable to this type of device and the information provided in this 510(k) summary.

However, I can extract the acceptance criteria and performance data for the mechanical and functional tests that were performed to support the device's substantial equivalence.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "All samples passed testing and met acceptance criteria." While the specific numerical acceptance criteria for each test are not explicitly detailed (e.g., "tensile strength must be > X N"), the general statement indicates that the device met pre-defined requirements for these performance characteristics. The table below lists the performance tests conducted, implying that the acceptance criterion for each was successful completion without failure, demonstrating performance comparable to or better than the predicate devices and ensuring safety and effectiveness.

Study Information Specifics:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document states "All samples passed testing," but does not specify the sample size (N) used for each of the performance tests.
   • The data provenance is from non-clinical tests conducted by Medtronic Xomed, Inc. This testing is typically done in a lab setting, not on human subjects.
   • The data is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

   • N/A. This device's testing involves mechanical and functional performance, not diagnostic interpretation requiring expert ground truth in the context of a medical imaging or AI study. The ground truth for these tests is based on engineering specifications and physical measurements/observations of device performance against predefined criteria.

3. Adjudication Method for the Test Set:

   • N/A. Since this involves mechanical/functional tests against engineering specifications, there is no "adjudication" in the sense of reconciling human expert opinions. Test results are objectively measured or observed.

4. 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:

   • N/A. This device (Eustachian Tube Dilation Balloon) is not an AI-powered diagnostic tool, nor does it assist human readers in interpreting medical images. It is a surgical device.

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

   • N/A. This device does not have an "algorithm-only" performance component. It is a physical medical device.

6. The Type of Ground Truth Used:

   • The ground truth used for this type of device relies on engineering specifications, physical measurements, and adherence to established performance standards (e.g., ISO, ASTM, internal Medtronic criteria). For example, a "passed" result for tensile strength means it met a minimum force before breaking, or "passed" for inflation means it inflated to the specified dimensions without bursting within a given pressure range.

7. The Sample Size for the Training Set:

   • N/A. There is no "training set" in the context of this device's mechanical and functional testing, as it is not an AI/machine learning model.

8. How the Ground Truth for the Training Set was Established:

   • N/A. This question pertains to AI/machine learning model development, which is not relevant to the type of device and testing described in this 510(k) summary.

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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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To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.

The XprESS ENT Dilation System is intended to recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. The XprESS device combines features of a curved suction tip and an ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and Eustachian tubes within the same patient.

The XprESS device curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS ENT Dilation System is provided sterile and for single use only.

The Xpress ENT Dilation System includes the XprESS device, Inflation Syringe, Bending Tool, and two Extension Lines. The XprESS LoProfile and Ultra ENT Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro ENT Dilation System also includes a Tuohy Adapter.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is a 510(k) summary for a medical device (XprESS ENT Dilation System) and does not contain acceptance criteria or a detailed study description in the specified format.

The document states that "The primary efficacy endpoint was met with Eustachian tube balloon dilation demonstrating superiority over medical management for improvement in ETDQ-7 symptom scores (p

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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:

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