(85 days)
To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
The XprESS Multi-Sinus Dilation System is intended to recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS Multi-Sinus Dilation System is provided sterile and for single use only. The Xpress Multi-Sinus Dilation System includes the XprESS device, Inflation Syringe, Bending Tool and two Extension Lines. The XprESS LoProfile and Ultra Multi-Sinus Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro Multi-Sinus Dilation System also includes a Tuohy Adapter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the XprESS Multi-Sinus Dilation System:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document doesn't explicitly state quantitative acceptance criteria in a typical tabular format with specific thresholds to be met (e.g., "Success Rate > 90%"). Instead, the performance claims are presented as achieved outcomes.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Procedural Technical Success Rate | 100% (157 out of 157 attempted dilations) |
| Complication Rate | 0% (No complications reported) |
| Device or Procedure-Related Adverse Events | 0% (No adverse events reported) |
| Safe and Effective | Demonstrated through clinical testing |
| Substantially Equivalent to Predicate | Achieved based on technological characteristics and performance data |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 50 subjects (with 157 attempted sinus dilations).
- Data Provenance: Prospective, multicenter, single-arm study conducted in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on procedural success and complication rates, which were likely determined by the treating physicians and reported in the clinical study. It's not a diagnostic AI device where external expert review of outputs for ground truth is typically required.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given it's a procedural device study focusing on success and complications, data would typically be collected and reported by the clinical sites and then aggregated and analyzed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or AI-assisted interpretation devices to compare human performance with and without AI assistance. The XprESS device is a surgical instrument.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No, a standalone (algorithm only) performance study was not done. The XprESS Multi-Sinus Dilation System is a physical medical device, not an algorithm or AI. Its performance is tied to its physical use.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the outcomes measured in the clinical study:
- Procedural Technical Success: This would be determined by direct observation during the procedure by the treating physician(s) – i.e., whether the dilation was successfully completed.
- Complication Rate: Recorded by clinical staff and physicians based on adverse events occurring during or after the procedure.
8. The Sample Size for the Training Set
Not applicable. The XprESS Multi-Sinus Dilation System is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 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.