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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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Intended Use: The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
Indications for Use: The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

The Sinus Dilation System with Cannulated Instrument consists of a disposable balloon which is mounted on a reusable cannulated delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic guidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to guide the device to the sinus ostium using endoscopic visualization. The instrument cannulation provides a working channel for suction, irrigation, etc.

The provided document K131709 describes a "Sinus Dilation System with Cannulated Instrument." The submission is a Special 510(k) notice for a modification to a previously cleared device (ENTrigue® Sinus Dilation System, K121351).

This type of device is classified as a Class I medical device (exempt from 510(k) requirements) under 21 C.F.R. § 874.4420, an "Ear, Nose, and Throat manual Surgical Instrument" with product code LRC. Due to its classification and the nature of the submission (Special 510(k) for a modification), the regulatory requirements for showing effectiveness through clinical studies involving human patients, as would be expected for AI/diagnosis devices, are not applicable here.

The "acceptance criteria" and "device performance" in this context refer to engineering and biocompatibility testing rather than diagnostic performance metrics like sensitivity, specificity, or AUC which are typical for AI/CADe devices.

Here's an analysis based on the provided text, indicating what information is present and absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of units tested) for the bench tests (fatigue life, human factors, articulation/lock, cleaning/sterilization). It only states that "Bench testing was conducted."
• Data Provenance: The data is from "Bench testing," meaning it was conducted in a laboratory or manufacturing environment. There is no mention of country of origin for the data or whether it was retrospective or prospective, as this is laboratory testing, not clinical data from patients.

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

• This question is not applicable to this type of device and study. The "ground truth" for a mechanical device's performance (like articulating, locking, or fatigue life) is generally based on engineering specifications and validated testing protocols, not expert clinical interpretation of data. Human factors verification might involve users (physicians or other healthcare personnel), but their number or qualifications as "experts to establish ground truth" in the diagnostic sense is not relevant here and not specified.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers when establishing ground truth for diagnostic decisions. Since this is a submission for a mechanical device based on bench testing, such methods are not relevant or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant to diagnostic devices, particularly AI-driven ones where human readers' performance is compared with and without AI assistance. This submission is for a mechanical surgical instrument.

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

• No, a standalone performance study was not done. This concept is only applicable to AI/algorithm-based diagnostic devices. The device in question is a physical surgical instrument; its performance is always "human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering specifications and validated test protocols. For example, a successful fatigue life test means the device withstood a specified number of cycles without failure, as per its design requirements. Successful cleaning and sterilization validation means it met established standards for those processes. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a physical surgical instrument modification. Training sets are relevant for machine learning algorithms.

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

• This question is not applicable for the same reason as point 8.

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