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The Relieva SpinPlus Nav™ Balloon Sinuplasty System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the Relieva SpinPlus Nav™ Balloon Sinuplasty System is intended to provide a means to access the sinus space, within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

The Relieva SpinPlus Nav™ Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT® ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy

The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is packaged with a handle with integrated flexible balloon catheter and Sinus Navigation Guidewire, and three RELIEVA® Spin Sinus Guide Catheter Tips. The system features a handle with an integrated flexible balloon catheter. Features of the handle include a sinus guide tip release button, a suction system, a balloon guard, and several gripping features to grip the device. The guide tip release button must be depressed to separate the sinus guide catheter tip from the handle system. The suction system consists of a suction line and a suction port. Suction may be used to clear the field of fluids and/or blood. The suction line is attached to the proximal end of the handle system and may be removed if desired. The suction port may be covered by the user's finger to increase the suction flow rate. A clear balloon guard is connected to the distal end of the handle system and protects the sinus balloon during sinus guide catheter tip exchanges. The Handle features a wire slider, wire spinner, balloon slider, sinus balloon, handle markers, and proximal connections. The wire slider allows the user to advance, retract and spin the sinus navigation guidewire with a single hand while simultaneously supporting the handle. The balloon slider allows the user to advance and retract the sinus balloon catheter to the target sinus ostia and outflow tract, to enable dilation. The integrated connector enables the device to be interfaced to the ACCLARENT ENT™ Navigation System to facilitate EM navigation. The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT ENT™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy via electromagnetic navigation.

This document describes the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System. The information provided focuses on technical characteristics and non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria in patient outcomes. Therefore, some of the requested information, specifically regarding sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth establishment for training, is not available from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of a patient cohort. The performance evaluation relies on non-clinical bench testing and simulated use testing with ENT surgeons. The number of instances or items tested for each bench test is not provided (e.g., how many balloons were burst tested, how many times was the device used in simulated use).
• Data Provenance: The data is primarily from non-clinical, laboratory-based testing (bench tests, accelerated aging, biocompatibility, sterilization validation) and simulated use testing performed with ENT surgeons. There is no mention of data from human patients or a specific country of origin in the context of a clinical study.

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

• Number of Experts: For the "simulated use testing," ENT surgeons were involved. The exact "number of experts" is not specified (e.g., "ENT surgeons" could imply more than one, but no specific count is given).
• Qualifications of Experts: The experts are identified as "ENT surgeons," indicating their medical specialty relevant to the device's use. No further details on their experience (e.g., "10 years of experience") are provided.
• Ground Truth: In the context of simulated use, the "ground truth" would be the successful procedural outcome as observed and judged by these ENT surgeons in a simulated environment (i.e., effective access and dilation).

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the simulated use testing or any other part of the performance evaluation. The results are presented as having "demonstrated" specific outcomes.

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 conducted. The document states, "Clinical data was not necessary for the RELIEVA SPINPLUS™ NAV Balloon Sinuplasty System." The evaluation was based on non-clinical performance and simulated use data to establish substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

• This device is a physical medical instrument (a balloon sinuplasty system) and does not involve an "algorithm" or AI in the traditional sense of image analysis or decision support for diagnostics. It is used in conjunction with an "ACCLARENT ENT™ Navigation System," which is a separate system (K161701 for its navigation accuracy testing). The performance reviewed here is an instrument that aids surgeons, not a standalone AI algorithm. While navigation accuracy was tested for the combined system, it's not an "algorithm only" performance evaluation.

7. The Type of Ground Truth Used

• The "ground truth" for the various non-clinical tests was based on engineering specifications, industry standards, and established metrics for material properties, mechanical integrity, and biological safety (e.g., burst pressure limits, sterility assurance levels, biocompatibility standards).
• For the simulated use testing, the "ground truth" was established by expert observation and judgment of ENT surgeons regarding the device's ability to effectively access and dilate paranasal sinuses in a simulated environment.

8. The Sample Size for the Training Set

• The document describes a device approval process based on substantial equivalence to predicate devices through non-clinical and simulated use testing. It does not mention a "training set" as would be relevant for machine learning algorithms or for establishing a new clinical efficacy profile.

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

• As no "training set" for an algorithm or new clinical efficacy was described, this information is not applicable and not present in the document.

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