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The RELIEVA TRACT™ Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17 years or older.

The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile device, which is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. It is intended for use in ages 17 years or older. The RELIEVA TRACT™ Balloon Dilation System is composed of:

• A RELIEVA TRACT™ Balloon Catheter, which consists of an integrated shaft system and a high-pressure balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the balloon with sterile water or saline via the ACCLARENT® Balloon Inflation Device (K090660). The inner lumen permits the use of the RELIEVA TRACT™ Stylet to facilitate advancement of the balloon catheter to the target location, such as the nasal passage in the region of the inferior turbinate and nasal septum. The proximal end of the RELIEVA TRACT™ Balloon Catheter consists of a luer that is used for inflation of the balloon and a secondary luer that is used for stylet access. The balloon is inflated by injecting sterile water or saline through the inflation luer.
• A RELIEVA TRACT™ Stylet, which is an optional accessory and intended to facilitate advancement of the Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.

This document is a 510(k) Summary for a medical device, the RELIEVA TRACT™ Balloon Dilation System. The request is to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data validation (e.g., test set, experts, ground truth).

However, this document does not contain information about the performance of a software or AI-based medical device, nor does it detail a study involving a test set, expert consensus for ground truth, or MRMC studies.

This 510(k) is for a physical medical device (a balloon dilation system) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (e.g., sterilization validation, biocompatibility, simulated use testing on cadavers).

Therefore, many of the requested bullet points, which are typically relevant for the validation of AI/software medical devices, cannot be answered from the provided text. The document explicitly states:

• "Clinical data was not necessary for the RELIEVA TRACT™ Balloon Dilation System." (Page 6)

Below is an attempt to answer the questions based on the available information, highlighting where the requested details are not present in the document.

Acceptance Criteria and Device Performance Study (RELIEVA TRACT™ Balloon Dilation System)

This 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance and simulated use testing, rather than a clinical study or a study specifically validating a data-driven AI/software component with a test set and ground truth.

1. Table of acceptance criteria and the reported device performance:

The document broadly states that the device "met all performance acceptance criteria," and then lists types of testing performed. Specific numerical acceptance criteria for each test are not detailed in this summary.

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

• Sample Size: Not specified. The document mentions "simulated use testing on cadavers." The number of cadavers or specific test instances is not provided.
• Data Provenance: "Cadavers" are mentioned for simulated use testing. No information on country of origin or whether the testing was retrospective or prospective. Given it's simulated use, it would typically be prospective for the purpose of the study.

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.
• Qualifications of Experts: Not specified. The simulated use testing included "evaluators" who assessed the packaging and instructions for use, but their number and qualifications (e.g., medical professionals, engineers) are not detailed.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: No, this type of study was not performed. This device is a physical medical instrument, not an AI/software. The document explicitly states "Clinical data was not necessary."

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

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

• For the simulated use testing, the "ground truth" would implicitly be the successful navigation, deployment, and dilation of the device as per its design specifications and intended use in the cadaveric model. This would likely be assessed by professional evaluators (e.g., engineers, medical device specialists, or potentially clinicians), but the specific method (e.g., visual inspection, measurement, functional assessment against a defined standard) is not detailed, nor is it based on expert consensus in the sense of diagnostic image interpretation.

8. The sample size for the training set:

• Training Set: Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

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The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.

The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy.

The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.

The provided text describes the acceptance criteria and the results of various bench tests for the aeris Balloon Dilation Catheter as part of a 510(k) submission for substantial equivalence. It does not include information about a study involving human readers, AI, or specific details on studies for ground truth establishment for a test set. This is a technical device submission, not an AI/algorithm-based diagnostic device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides multiple tables summarizing the bench testing results for different sizes of the aeris Balloon Dilation Catheter and a comparison with predicate devices. For conciseness, a combined table of the types of tests and their general acceptance criteria and performance will be presented, referencing the detailed tables for specific values.

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

The document details bench testing for various physical attributes of the device and biocompatibility testing. It does not describe a clinical "test set" in the context of diagnostic AI models (i.e., human patient data with ground truth labels).

• Bench Testing: The sample sizes for each specific bench test (e.g., number of catheters tested for inflation time, fatigue, etc.) are not explicitly stated in the provided summary tables. The results are presented as "Pass" for each test.
• Biocompatibility Testing: The number of biological samples or animals used for tests like L929 MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Acute Systemic Toxicity, and Intracutaneous Irritation are not specified.
• Data Provenance: Not applicable in the context of clinical patient data. The tests are laboratory-based bench tests and preclinical biocompatibility assessments.

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

This question is not applicable to the provided document. The submission is for a medical device (balloon dilation catheter) and involves physical and biological performance testing, not a diagnostic AI device requiring expert-established ground truth from clinical images or data. Bench test acceptance criteria are based on engineering specifications and regulatory standards (e.g., ISO standards).

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" involving expert review or adjudication in the context of AI/diagnostic performance described in this document.

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 a medical device for dilating strictures of the airway, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This document pertains to a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is established by:

• Engineering Specifications: Defined tolerances for physical dimensions (e.g., balloon working length, diameter), time limits (e.g., inflation/deflation time), force requirements (e.g., bond tensile force), and operational limits (e.g., maximum inflation pressure).
• Regulatory Standards: Adherence to ISO standards (e.g., ISO 594-1 & 594-2 for luer fittings, ISO 10555 for bond tensile force).
• Visual Inspection: "No visual signs of kinking or damage" for insertability/removability, "No evidence of balloon leakage" for fatigue, "No visual signs of damage" for torqueable.
• Biocompatibility Assessment: Biological responses meeting defined safety thresholds (e.g., reactivity grade of mild or less, no sensitization response, no signs of toxicity, differences in scores less than 1).
• Equivalence to Predicate Devices: For radiopacity, the visibility of the aeris marker bands needed to be "Equivalent" to that of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device.

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

Not applicable. There is no training set for an AI/algorithm described in this document.

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