(50 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 Infusion 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. The items packaged with the XprESS Multi-Sinus Dilation Tool include the Inflation Device, Bending Tool and two Infusion Lines.
The provided text describes the XprESS Multi-Sinus Dilation Tool, a medical device, and its 510(k) submission (K121943) for clearance. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device.
Therefore, many of the requested categories related to acceptance criteria, detailed study design, ground truth establishment, expert involvement, and comparative effectiveness studies are not explicitly present in the provided text. The submission is primarily about demonstrating that the new device is as safe and effective as an already marketed predicate device, relying on design verification and simulated use rather than extensive clinical trials or AI performance evaluations.
Here's an analysis based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of specific, quantified acceptance criteria. Instead, it makes a general statement about meeting design specifications.
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | "Performance testing of the XprESS device consisted of biocompatibility..." |
| Design Verification | "...design verification testing..." |
| Simulated Use Performance | "...simulated use in a cadaver model to support the additional suction tip size." |
| Withstand Multiple Inflations | "The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations..." |
| Withstand Device Tip Manipulations | "...and device tip manipulations in a surgical case wherein all 6 sinus ostia are being dilated." |
| Meets Design Specifications | "Performance testing showed that the device meets design specifications and performed as intended." |
| Substantial Equivalence | "The XprESS device is substantially equivalent to the predicate device." |
| Safety and Effectiveness | "Performance testing has demonstrated that the device is safe and effective..." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The text mentions "simulated use in a cadaver model," but the number of cadavers or specific tests performed is not detailed.
- Data Provenance: The simulated use was conducted in a "cadaver model." This implies an ex vivo setting, likely in the country where the company (Entellus Medical, Inc. - Plymouth, MN, USA) is based. The data would be considered prospective for the purpose of this submission, as it was generated specifically for the device verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable/Not specified. The simulated use involved a cadaver model to test mechanical performance and the ability of the device, not to establish a "ground truth" for diagnostic or AI-related outcomes. The "ground truth" in this context would be related to the device's mechanical integrity and functionality, which is evaluated against engineering specifications, not expert diagnostic consensus.
4. Adjudication Method for the Test Set
Not applicable/Not specified. Since this is not a study requiring expert interpretation or consensus for a diagnostic outcome, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done.
- No AI component or human-in-the-loop performance evaluation is mentioned. The device is a surgical tool, not an AI-assisted diagnostic or therapeutic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical surgical tool; there is no "algorithm" in the sense of an AI or diagnostic algorithm being tested in standalone mode.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on engineering specifications and functional performance in a simulated environment. For example, the device must withstand a certain number of inflations without failure, or the balloon must dilate to a specific diameter. These are objective measurements against predefined design requirements.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and testing are based on traditional engineering principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.