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Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which 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 a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Gide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Mectronic Surgical Instruments are also compatible with the UC'M POWEREASE™ System or AO style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.

The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The instruments are compatible with Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation™ System or MAZOR X Stealth™ Edition System to track the instruments in the surgical field.

The document provided does not describe an AI/ML device, and therefore does not contain information about acceptance criteria or supporting studies that would typically apply to such devices (e.g., sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, or standalone performance).

The device in question, "Navigated Anterolateral Disc Prep Instruments," is a surgical instrument used with navigation systems (StealthStation™ System and MAZOR X Stealth™ Edition) to assist surgeons in precisely locating anatomical structures during spinal surgery. The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on identical intended use, fundamental scientific technology, materials, sterilization method, and compatibility.

While "Performance Testing" is mentioned (Section VII), this refers to traditional medical device validation for functionality and compatibility, not AI/ML model performance. The tests include:

• Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
• CAD Model Verification: Confirmed CAD models are accurately reflected in the application software.
• Tools Package Functional Verification: Confirms that the Spine tools package met required interface needs of the spine application software.
• NAV Simulated Use: No new testing completed.
• Anatomical Simulated Use: No new testing completed.

The document indicates that the "Navigated Anterolateral Disc Prep Instruments were previously cleared within (K192336, S.E. 11/22/2019) and are not undergoing any design changes." The current submission (K211441) primarily seeks additional use with the MAZOR X Stealth™ Edition System, extending compatibility from the StealthStation™ System.

Therefore, the requested information about acceptance criteria for an AI/ML device, associated study details, and ground truth establishment is not applicable to this submission.

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The Navigated Disc Preparation Instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to facilitate implant size selection. The Navigated Probe is intended to be used during pedicle preparations. The Navigated Inserters are intended to be used for the placement of an implant.

Navigated instruments are specifically designed for use with the StealthStation™ System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel as the predicate, per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate to facilitate a discectomy or boney resection during spinal surgery. The instruments are compatible with Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation® Image Guidance System to track the instruments in the surgical field.

This document describes the regulatory clearance for the Navigated Anterolateral Disc Prep Instruments designed for use with the Medtronic StealthStation™ System.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document provides a summary of performance testing but does not explicitly state numerical acceptance criteria or detailed reported device performance in a table format. However, it lists the types of tests conducted and their descriptions. The "reported device performance" is generally implied as passing the tests to ensure functionality and compatibility.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size for any of the tests conducted. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for the test sets. These details are typically provided in more comprehensive study reports or validation documentation, which are not fully contained within this FDA 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test sets. The tests described (e.g., navigation accuracy, simulated use, CAD model evaluation) suggest engineering and technical evaluations rather than clinical expert reviews for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not describe any adjudication method for the test set. Given the nature of the tests (functional and technical evaluations), formal adjudication methods like those used in clinical trials for expert-based ground truth might not be applicable or were not deemed necessary to be included in this summary.

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:

No, an MRMC comparative effectiveness study was not done. The device described is a set of navigated surgical instruments, not an AI-assisted diagnostic or interpretative system where "human readers" would be involved in interpreting data that the device processes. Therefore, this question is not applicable to the device under review.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is a set of physical surgical instruments designed to be used with a navigation system (StealthStation™) and operated by a human surgeon. It is not an algorithm-only or standalone AI system. Therefore, the concept of "standalone (algorithm only)" performance without human intervention is not applicable to this device. The navigation system itself might undergo separate standalone performance testing, but this document focuses on the instruments.

7. The type of ground truth used:

The "ground truth" for the tests described appears to be based on:

• Engineering specifications and design requirements: For tests like "Navigation Accuracy Analysis," "CAD Model Evaluation," and "Spine Tools Package Functional Testing," the ground truth would be precise engineering measurements, CAD model data, and software interface requirements.
• Intended use functionality validation: For "Navigation Simulated Use" and "Verification & Validation," the ground truth involves confirming that the instruments perform as expected and meet their intended functional objectives.
• Material standards: For "Biocompatibility," the ground truth is adherence to established ASTM material standards.

8. The sample size for the training set:

The document does not mention a training set as this device is not an AI/machine learning system that requires model training. The tests described are related to the physical and functional performance of surgical instruments.

9. How the ground truth for the training set was established:

As there is no training set for this type of device, this question is not applicable.

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