Search Results

The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate 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 Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate 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 Balloon Sinuplasty System is an integrated device that incorporates an ergonomically designed Handle, an illuminated Guidewire, a Sinus Balloon Catheter, and a Guide Catheter. The Sinus Balloon Catheter enables sinus irrigation without instrument exchanges. The principles of operation of SpinPlus are similar to the predicate devices in allowing for access and enlargement of sinus ostia, and irrigation from within the target sinus.

The provided document is a 510(k) summary for the Relieva SpinPlus Balloon Sinuplasty System. It describes the device, its indications for use, and performance data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI/algorithm-based medical device performance evaluation.

The "Performance Data" section in the 510(k) summary (page 3) states:

"Bench testing met all acceptance criteria for attributes such as simulated use testing, dimensional attributes, cycle fatigue, balloon burst, bond separation, irrigation flow rate and wire light output. Testing also showed that the SpinPlus Balloon Sinuplasty System is biocompatible."
"The sterilization process has been validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals have been tested and meet ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as “non-pyrogenic”."
"Packaging shelf life has been established to be 3 months per ASTM F1980-07."
"Clinical data were not necessary for the SpinPlus Balloon Sinuplasty System. The performance data demonstrate that the device performs as intended."

This information pertains to engineering and safety performance of a physical medical device (balloon sinuplasty system), not the performance of an AI/algorithm. Therefore, I cannot extract the requested information regarding AI acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and testing described in this document.

Ask a specific question about this device