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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.

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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The EM Sinus Dilation System is intended for use in sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and sphenoid sinuses.

The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system.

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 guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The EM Sinus Dilation System composes of sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilatation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape with the appropriate angle that allow for entry into the scarred sinus outflow tract. The inflator consists of a plunger, barrel and extension tube.

Each sinus dilation instrument is intended to be used in conjunction with the Fusion software on a Medtronic computer-assisted surgery system.

Inside of each sinus seeker is an EM tracker. The emitter on the Fusion System generates a low-energy magnetic field to locate the tracker mounted on the sinus seeker. Then, the software displays the location of the sinus dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seeker's balloon can be inflated with saline solution, using the inflator to expand the outflow track of the targeted sinus.

The provided 510(k) summary for the Medtronic EM Sinus Dilation System (K132297) focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and intended use. It does not include a detailed study proving the device meets specific performance acceptance criteria in the way a diagnostic AI device summary might.

The submission is for a surgical instrument with electromagnetic tracking, rather than an AI/ML-driven diagnostic tool. Therefore, the typical acceptance criteria and study designs (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) for AI-powered devices are not applicable or detailed in this document.

However, based on the information provided, I can extract what is stated regarding performance testing and how it relates to ensuring "acceptable navigational accuracy."

Here's a breakdown of the available information in the requested format, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Test samples" but does not quantify them or describe the nature of these samples (e.g., physical phantoms, cadaveric models, clinical data).
• Data Provenance: The testing was "Benchtop and simulated environment." There is no mention of country of origin for data, nor whether it was retrospective or prospective, as it appears to be primarily lab-based testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This information is not provided because the device is a surgical instrument with navigation capabilities, not a diagnostic tool requiring expert interpretation of images or clinical data for ground truth establishment. The "ground truth" for navigational accuracy would likely be established by known physical measurements in the simulated environment.

4. Adjudication Method for the Test Set

• Not applicable/Not described. Given the nature of the device and testing, expert adjudication in the context of diagnostic performance is not relevant here. Navigational accuracy would typically be objectively measured against known spatial references.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study was not done. This type of study is relevant for evaluating human reader performance, particularly with diagnostic imaging tools where human interpretation is a key component. This device is a surgical instrument, and its performance is evaluated in terms of its physical function and navigational accuracy rather than diagnostic reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, effectively. The "System Accuracy Method" is described as "Benchtop and simulated environment." This indicates that the functional and navigational accuracy of the device, likely using its electromagnetic tracking algorithm, was evaluated in a controlled setting without a human surgeon performing a full procedure. The document states the system "displays the location of the sinus dilation instrument's tip," implying an objective measurement of this display accuracy.

7. The Type of Ground Truth Used

• Implied objective measurements in a simulated environment. While not explicitly stated with details like "pathology" or "outcomes data," the "Benchtop and simulated environment" testing for "System Accuracy" and "navigational accuracy" suggests that the "ground truth" would be precisely known physical positions or measurements within the controlled test setup. For example, a known target position versus the device's reported position.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is a mechanical surgical instrument with electromagnetic tracking. It does not refer to an AI/ML algorithm that would typically require a "training set" in the conventional sense (e.g., for image recognition or predictive modeling). The "Fusion software" mentioned is likely a deterministic navigation system rather than a machine learning model that undergoes training.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not provided. As there is no explicit mention of a "training set" or an AI/ML model being trained with data in this submission, the method for establishing ground truth for such a set is not discussed.

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