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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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The Relieva Solo Elite Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the Relieva Solo Elite Sinus Balloon Catheter is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

The Relieva Solo Elite Sinus Balloon Catheter is a flexible catheter that is intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of a sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter. The subject device also has the capability to irrigate the sinus through the distal tip and three side holes on the distal end.

This is a 510(k) premarket notification for a medical device (Relieva Solo Elite Sinus Balloon Catheter), which typically demonstrates substantial equivalence to predicate devices rather than proving clinical efficacy or diagnostic accuracy with extensive human studies. Therefore, many of the requested elements for AI/device performance studies (like MRMC, expert consensus, training set details) are not applicable to this type of submission.

However, I can extract the relevant performance data and acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the Relieva Solo Elite Sinus Balloon Catheter met various performance acceptance criteria. While the specific numerical acceptance criteria values are not given, the categories of criteria and the confirmation that they were met are provided.

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

The document does not specify sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). These are typically detailed in the test reports themselves, which are referenced but not included in this summary document. The tests conducted are primarily engineering performance tests rather than clinical studies with patient data.

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

Not applicable. This device submission focuses on engineering performance and substantial equivalence, not diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This device submission focuses on engineering performance tests, not clinical performance requiring adjudication.

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-powered diagnostic device, and no MRMC study is mentioned or relevant.

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

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests would be the established engineering standards and material specifications. For example:

• Dimensional Specifications: Engineering drawings and measurement standards.
• Balloon Burst Pressure: Material failure limits and design specifications.
• Sterility: Microbiological validation guidelines (e.g., AAMI/ANSI/ISO 11135-1).
• Ethylene Oxide Residuals: Toxicology standards (e.g., ISO 10993-7).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. This is not an AI/machine learning device.

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