(140 days)
Use a single dilation device by transnasal approach to access and treat an individual anatomical location as follows:
· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Maxillary ostialethmoid infundibula in patients 2 years and older;
· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Frontal ostialrecesses in patients 12 years and older: may be used with LED Light fiber to locate, illuminate across nasal and sinus structures;
· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Sphenoid sinus ostia in patients 12 years and older;
• Dilation of the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older.
The SINUSPRIME Dilation System is intended to remodel or recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. Each packaged SINUSPRIME System includes a balloon device configured for a specific anatomy (frontal, sphenoid, maxillary, or Eustachian tube (ET) configuration) and an inflation device. The SINUSPRIME Dilation System combines features of an ostium seeker with the tissue expansion effect of balloon dilation. The SINUSPRIME Dilation System is provided sterile and for single use only. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. The SINUSPRIME LED Light Fiber consists of a flexible illumination fiber that allow physicians to locate, illuminate within, and trans-illuminate across nasal and sinus structures. The SINUSPRIME LED Light Fiber is optional and available packaged and pre-loaded only on the SINUSPRIME Frontal with LED model.
The provided text is a 510(k) summary for the Stryker ENT SINUSPRIME Dilation System. It outlines the device, its indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, study design, or ground truth establishment for an AI-based device.
The document discusses "Performance Data" but only states: "Performance testing involved biocompatibility, design verification (dimensional, strength, HFE/UE verification testing), packaging, shelf life and design validation with physicians (HFE/UE). Performance testing showed that the device meets design specifications and performs as intended." This refers to engineering and human factors testing for a physical medical device, not a study involving AI algorithm performance with a test set, expert readers, or ground truth in the context of diagnostic or prognostic capabilities.
Therefore, I cannot provide the requested information from this document. The SINUSPRIME Dilation System is a physical medical device (balloon catheter for dilation), not an AI/ML-based diagnostic or imaging device. The questions you've asked are typically relevant for AI/ML medical devices where performance metrics like sensitivity, specificity, AUC, or reader agreement are crucial for regulatory submission.
§ 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.