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To provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

The Sinus Balloon Catheter—Integrated Wire is a sinus balloon catheter that has an integrated guidewire. The Sinus Balloon Catheter—Integrated Wire allows access to and dilation of the sinus ostia and paranasal spaces with a single device.

The provided text describes a medical device, the "Sinus Balloon Catheter—Integrated Wire," and its 510(k) submission to the FDA. However, the document does not contain the specific details required to complete your request regarding acceptance criteria and the study that proves the device meets them.

The relevant section only states:

"The Sinus Balloon Catheter—Integrated Wire met all performance testing acceptance criteria."

And:

"The Sinus Balloon Catheter—Integrated Wire is substantially equivalent to the predicate devices as confirmed through relevant performance tests."

This indicates that performance testing was conducted and acceptance criteria were met, but the document does not elaborate on:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the given text. This document is a summary of the 510(k) process and regulatory filing, not likely to contain detailed performance study protocols and results. Such details would typically be in an accompanying technical report or design validation documentation, which is not included here.

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The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.

The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the InstaTrak Receiver. The Sinus Guide Adapter is used in conjunction with a Calibration Device that is compatible with the InstaTrak Navigation system. The Calibration Device is used to calibrate the tip position and the trajectory line of the Sinus Guide Catheter. Once calibrated, the Calibration Device is removed.

The Acclarent ReliENT™ Navigation Device is an accessory to the Sinus Guide Catheter, enabling navigation capability for diagnostic and therapeutic procedures in the sinus space.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter and Calibration Device met all performance testing acceptance criteria." However, specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) and their corresponding reported device performance values are not detailed in the provided text. The submission focuses on substantial equivalence based on meeting all general performance criteria.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly refers to "performance testing" being conducted.

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

The document does not provide information about the number of experts, their qualifications, or how ground truth was established for the specific performance tests.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No effect size of human readers improving with AI vs. without AI assistance is provided, as this device does not appear to involve AI.

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

This device is not an AI algorithm but a physical accessory for a navigation system. Therefore, a standalone algorithm-only performance study would not be applicable. The performance testing would relate to the physical and functional aspects of the adapter and calibration device.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance testing. Given the nature of a navigation device accessory, the ground truth would likely involve physical measurements and system accuracy assessments against known standards or reference points. It would not typically involve expert consensus, pathology, or outcomes data in the same way an image analysis algorithm would.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device (an accessory for a navigation system), not an AI/ML algorithm.

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

As this is not an AI/ML algorithm, there is no training set or ground truth establishment relevant to AI model training.

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