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510(k) Data Aggregation
(124 days)
NuVent EM Sinus Dilation System
The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used to
- locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia; or
- locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia.
The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.
The system and its associated applications should be used only as an adjunct for surgical quidance. They do not replace the surgeon's knowledge, expertise, or judgment.
The NuVent™ EM Sinus Dilation System comprises sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape and angle that allows for entry into the sinus outflow tract. The inflator consists of a plunger, barrel and extension tube.
Each sinus seeker is intended for use in conjunction with the Fusion software on a Medtronic computer-assisted surgery system. Inside each sinus seeker is an EM tracker. The emitter on the EM Computer-Assisted Surgery System generates a low-energy magnetic field to locate the tracker mounted inside of the sinus seeker. The software displays the location of the sinus seeker's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seekers balloon can be inflated with saline solution by using the inflator to expand the outflow of the targeted sinus.
The provided text describes a 510(k) premarket notification for the NuVent EM Sinus Dilation System. This device is an ear, nose, and throat (ENT) manual surgical instrument used in conjunction with a computer-assisted surgery system for sinus procedures. The submission seeks to expand the indications for use to include procedures on scarred, granulated, or previously surgically altered tissue, and also to explicitly state facilitating "dilation of the sinus ostia" in the indications.
The submission does not contain acceptance criteria for specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be expected for a diagnostic or AI-driven device. This is primarily because the device is a surgical instrument for physical manipulation and guidance, not a diagnostic tool that produces classification or quantitative results.
The "study" described is a clinical study to support the expanded indications, focusing on the safe and intended performance of the device in a specific patient population, not on meeting predefined statistical performance thresholds for an AI algorithm.
Based on the provided text, here is the information requested, with "N/A" where the information is not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a surgical instrument and not an AI or diagnostic device, the "acceptance criteria" discussed are related to the broader concepts of "substantial equivalence," "performance as intended," and "no new safety concerns." There are no quantitative performance metrics like sensitivity or specificity.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs as intended for expanded indications (on scarred, granulated, or previously surgically altered tissue). | The subject device performed as intended in a clinical study conducted in subjects with scarred, granulated, or previously surgically altered tissue. |
| No new safety concerns are raised. | The clinical study reported no adverse events attributed to the subject device. |
| Device is substantially equivalent to predicate device. | The subject and predicate EM Sinus Dilation System devices are identical in design and performance specifications. The difference in indications for use (specifically the addition of "scarred, granulated, or previously surgically altered" tissue and explicit mention of "dilation of the sinus ostia") was supported by the clinical study. No additional non-clinical testing was required as there were no design changes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not explicitly stated as a number of "subjects." The text mentions "subjects with scarred, granulated or previously surgically altered tissue were enrolled and treated in at least one frontal, sphenoid, or maxillary sinus." The exact number of subjects is not provided in this excerpt.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Prospective.
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)
N/A. This is a study to demonstrate the performance and safety of a surgical instrument in a clinical setting, not a study involving expert-derived ground truth for diagnostic accuracy. The "truth" is whether the device could be used as intended without issue and without new safety concerns, as observed by the operating surgeons. Though not called out explicitly regarding "ground truth," the study involved "surgeons" performing procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This type of adjudication is not applicable to a clinical study evaluating the performance and safety of a surgical instrument. The study was described as "non-randomized, non-blinded, single arm."
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
N/A. This device is a surgical instrument assisted by a computer navigation system, not an AI-assisted diagnostic imaging interpretation tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. The device is a physical surgical instrument that functions "in conjunction with the Medtronic Computer-Assisted Surgery System." It is inherently a "human-in-the-loop" device as it aids the surgeon, rather than performing tasks autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly assessed was clinical outcome and observed safety/performance during live surgical procedures. The clinical study evaluated whether the device "performed as intended and did not raise new safety concerns" in patients with the expanded indications.
8. The sample size for the training set
N/A. This submission describes a modification to an existing surgical device. There is no mention of an algorithm or AI model that would require a "training set."
9. How the ground truth for the training set was established
N/A. As there is no training set for an algorithm, this question is not applicable.
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