(30 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 device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. 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. XprESS is available in the following balloon sizes: 5 mm diameter, 18 mm length; 6 mm diameter, 8 mm length; 6 mm diameter, 18 mm length; 7 mm diameter, 18 mm length.
The provided text describes a medical device, the XprESS Multi-Sinus Dilation Tool, and its regulatory submission. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and performance as would be expected for a novel device.
Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device meeting these criteria (especially for AI/standalone performance, multi-reader multi-case studies, and ground truth establishment methods) is not present in the document, as it pertains to a different type of regulatory submission and device evaluation.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
The document states: "Performance testing showed that the device meets design specifications and performed as intended." Specific quantitative acceptance criteria are not detailed in this summary, nor are specific quantitative performance metrics published. The focus is on demonstrating equivalence to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Meets design specifications | Yes, performed as intended |
| Withstands multiple inflations | Yes, tested for multiple inflations in a surgical case (all 6 sinus ostia) |
| Withstands device tip manipulations | Yes, tested for device tip manipulations in a surgical case (all 6 sinus ostia) |
| Supports additional balloon size | Demonstrated through simulated cadaver model use |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated as a numerical sample size. The document mentions "simulated use in a cadaver model to support the additional balloon size." This implies one or more cadavers were used for testing.
- Data Provenance: The cadaver model is a simulated use environment. Country of origin for this testing is not specified but would likely be the US given the submission to the FDA. The nature of cadaver testing is generally considered prospective for the purposes of evaluating the device in a controlled environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable/Not mentioned. The testing described (mechanical testing, simulated cadaver use) does not involve expert interpretation for ground truth establishment in the context of diagnostic accuracy, which is what this question typically pertains to. The "ground truth" here is mechanical integrity and functionality, established through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not mentioned. Adjudication methods are typically for resolving discrepancies in expert interpretation, which is not the type of testing described here.
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:
Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The ground truth for the performance testing (design verification and simulated use) was based on engineering specifications and the observable functional performance of the device (e.g., successful dilation, withstand multiple inflations).
8. The sample size for the training set:
Not applicable. This device does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established:
Not applicable (as above).
§ 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.