(29 days)
For patients aged 18 and older, the Relieva Scout ™ Sinus Dilation System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
The Relieva Scout Sinus Dilation System is an integrated device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and an ergonomic handle. The sinus balloon may be inflated to dilate the frontal recess, frontal sinus ostia, and spaces within the frontal sinus cavity.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/algorithm based technology. The document describes a "Relieva Scout™ Sinus Dilation System", which is a manual surgical instrument, not an AI or algorithm-based device.
The "Performance Data" section (on page 1) mentions:
- Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, balloon burst, and bond separation.
- Testing also showed that the Scout Balloon Sinuplasty System is biocompatible.
- The sterilization process was validated per AAMI/ANSI/ISO 11135-1:2007.
- Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements.
- Packaging shelf life was established via accelerated aging per ASTM F1980-07.
This information refers to engineering and material-based performance, not the kind of AI-driven performance (like sensitivity, specificity, or reader improvement) that would require the specific details you've asked for (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance).
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.