(64 days)
To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults 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 Tool is intended to remodel or 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 Tool is provided sterile and for single use only.
This document is a 510(k) premarket notification for a medical device called the "XprESS Multi-Sinus Dilation Tool". It is a submission to the FDA seeking clearance to market the device, claiming substantial equivalence to a previously cleared predicate device.
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a typical format. Instead, it discusses the outcomes of various tests. Based on the "Performance Data" section (Page 4), the implicit acceptance criteria are that the device meets design specifications and performs as intended.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility (Device materials are safe for human contact) | "Performance testing of the XprESS device consisted of biocompatibility..." (Implies successful testing without specific details, but the FDA clearance suggests it met the necessary standards.) |
| Design Verification (Device meets its design specifications) | "Performance testing of the XprESS device consisted of ... design verification testing..." (Implies successful verification that the device met its specifications as designed.) |
| Simulated Use Performance (Device functions as intended in a simulated environment) | "Performance testing of the XprESS device consisted of ... simulated use in a cadaver model..." (Implies successful performance in simulating clinical use.) The document also states: "The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations in a surgical case wherein all 6 sinus ostia are being dilated." |
| Sterilization Efficacy (Device can be effectively sterilized) | "Performance testing of the XprESS device consisted of ... sterilization to support the additional Ultra suction tip and balloon size." (Implies successful sterilization validation.) |
| Substantial Equivalence (Device is as safe and effective as the predicate) | "Performance testing showed that the device meets design specifications and performed as intended." and "In conclusion, the indications for use and technological characteristics are the same as or equivalent to the predicate device. Performance testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- The document mentions "simulated use in a cadaver model." However, it does not specify the sample size (e.g., number of cadavers or number of procedures performed).
- The data provenance is retrospective/simulated, as it was done in a cadaver model, not live patients. The country of origin for the cadaver model data is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide information regarding the number of experts or their qualifications for establishing ground truth in the simulated use testing. For a device like this, ground truth would likely be based on successful access, dilation, and lack of damage in the cadaveric sinuses, assessed by qualified medical professionals (e.g., ENT surgeons).
4. Adjudication Method for the Test Set
- The document does not describe any formal adjudication method for the simulated use testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The device is a surgical tool, not an AI diagnostic imaging device that would typically involve human readers interpreting images. The evaluation primarily focuses on the device's physical performance, safety, and functionality.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This question is not applicable to the XprESS Multi-Sinus Dilation Tool. This is a manual surgical instrument, not an AI algorithm. Its performance is always with a human (surgeon) in the loop.
7. The Type of Ground Truth Used
- The ground truth for the performance testing (e.g., in the cadaver model) would have been based on direct observation and assessment of the physical outcomes (e.g., successful dilation, structural integrity, absence of damage) within the simulated environment by qualified personnel. It's a functional ground truth rather than a diagnostic one like pathology or expert consensus on an image. For biocompatibility, the ground truth is established by standardized testing protocols for material safety.
8. The Sample Size for the Training Set
- This question is not applicable. The XprESS Multi-Sinus Dilation Tool is a mechanical surgical instrument, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for a mechanical surgical instrument.
§ 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.