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The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.

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-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.

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-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Stylet is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.

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-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Stylet is indicated for use in the following procedures:

• General ventricular catheter placement
• Pediatric ventricular catheter placement
• Tumor resections
• Skull base procedures
• Craniotomies/craniectomies
• Transsphenoidal procedures

The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computerassisted surgery systems using electromagnetic navigation and cranial software.

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-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Touch-n-Go Pointer is indicated for use in registent anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.

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-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medironic computer-assisted surgery systems using electromagnetic navigation and cranial software.

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-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Navigation Pointer is indicated for use in the following procedures:

• General tumor resections
• Pediatric tumor resections
• Skull base procedures
• Craniotomies/craniectomies
• Transsphenoidal procedures

The AxiEM™ Instruments (Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer) and Trackers (Skull-Mount Patient Tracker. Non-Invasive Patient Tracker) are singleuse, sterile devices compatible with AxiEM™-enabled Medtronic computer assisted surgery systems. The instruments and trackers are electromagnetically navigated devices used for the purpose of localizing patient anatomy, patient registration, and tracking patient location during stereotactic surgery procedures.

Each device incorporates a tracking system within the instrument or tracker. The mobile emitter of the navigation system generates a low-energy magnetic field that is detected by the tracking system within the device. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.

The provided FDA 510(k) summary for the Medtronic Navigation, Inc. devices (Stylet, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker) details the acceptance criteria and the studies performed to demonstrate equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state numerical sample sizes for each test. However, it indicates that "Testing was completed" and "The instruments tested demonstrate conformance," implying that a sufficient number of samples were used to obtain statistically relevant results according to Medtronic's internal testing protocols and relevant international standards (e.g., ISO, IEC).

The data provenance is from non-clinical testing performed by Medtronic Navigation, Inc. The document does not specify the country of origin of the data beyond the company's US address. It is retrospective in the sense that the studies were completed prior to this 510(k) submission.

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

This submission deals with the technical performance of medical devices (accuracy, safety, material properties, etc.) and not with clinical diagnostic performance that would typically require expert ground truth. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists for image reading) is not applicable here. The "ground truth" for these tests is based on objective measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is objective performance testing against defined metrics rather than interpretive assessment requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (like AI algorithms for image interpretation) to compare the performance of human readers with and without AI assistance. The submitted devices are surgical instruments and patient trackers for navigation systems, which have objective physical performance metrics rather than interpretive diagnostic outcomes.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, standalone performance (algorithm only/device only performance) was done. The entire "Performance Data" section (Section VII) describes the standalone testing of the devices' accuracy, safety, mechanical properties, and biocompatibility. The reported accuracy of "<2mm positional error and <2 degrees trajectory error" is a direct measure of the device's inherent performance.

7. The Type of Ground Truth Used:

The ground truth used for these technical performance tests is primarily based on:

• Physical measurements against known standards and specifications: For accuracy (e.g., using precision measurement tools to determine positional and trajectory error against a known target).
• Compliance with international standards: For electrical safety (IEC 60601-1, IEC 60601-1-2) and biocompatibility (ISO 10993 series).
• Simulated environmental conditions: For skin shift and chemical resistance, simulating real-world use conditions to assess performance.
• User feedback/testing: For usability.

8. The Sample Size for the Training Set:

Not applicable. These devices are physical instruments and trackers; they are not machine learning or AI algorithms that require a "training set" in the traditional sense of data-driven model development. Their performance is inherent to their design, materials, and manufacturing, which are validated through testing.

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

Not applicable, as there is no training set for these devices.

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