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Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist 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 medical conditions 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 Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.

The Catalyft™ PL Expandable Interbody System navigated instruments consist of an Inserter (Outer), Inserter Inner Sleeve, Trials, a NAV Verification Tool, and Navigated Rotating Shavers that were cleared in K210425. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438. S.E. 06/02/2005; K201189. S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

Please note that the Navigated Rotating Shavers were previously cleared for use on MAZOR X™ (K203005, S.E. 10/27/2020), and per this 510(k) submission, the Rotating Shavers can be used for disc prep and to trial for Catalyft™ PL on MAZOR XTM.

The Anteralign™ TL navigated instruments consist of an Inserter and Trials that were originally cleared in K212524. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438, S.E. 06/02/2005; K201189, S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

The CD Horizon™ Solera™ Vovager™ Spinal System navigated instruments consists of new Drivers, which will be manufactured from stainless-steel. Medtronic is seeking clearance of the Drivers to be Navigated and Trajectory Guided via MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) and Powered via IPC™ POWEREASE™ System (K111520. S.E. 10/26/2011: K123270. S.E. 01/11/2013). To enable trajectory guidance compatibility, the Drivers have been designed to work with the MAZOR X™ Arm Guides. To enable power, the Drivers may also be attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The provided document is a 510(k) summary for Medtronic surgical instruments, outlining their substantial equivalence to predicate devices. It focuses on the compatibility of these instruments with the MAZOR X™ system. However, the document does not contain the detailed acceptance criteria and performance data typically found in a clinical study report for proving a device meets acceptance criteria.

Specifically, it mentions "Performance Testing" and "Discussion of the Performance Testing" but then lists generic test descriptions rather than specific quantitative acceptance criteria or reported device performance metrics. There is no information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide the detailed study information. The document serves as a high-level summary for regulatory submission, not a detailed performance study report.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document lists general "performance testing" but does not define quantitative acceptance criteria (e.g., "accuracy shall be within X mm") or specific numerical results.
• Sample sizes used for the test set and the data provenance: No information on the number of cases, images, or subjects used in the "performance testing," nor any details on whether it was retrospective or prospective, or data origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a ground truth established by experts for performance evaluation. The "ground truth" here is likely engineering validation against design specifications or a simulated environment, not clinical expert consensus.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no human adjudication described.
• 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 surgical navigation instrumentation, not an AI / image analysis device that would assist human readers in diagnosis.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "performance testing" described is likely functional verification of the instruments and their compatibility with the navigation system, not a standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but inferred to be engineering specifications and simulated use assessments rather than clinical ground truth.
• The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

What can be inferred or extracted (though still lacking detail for your specific request):

• Device Type: Surgical Instruments for spinal surgery, intended to assist in precisely locating anatomical structures using navigation systems (MAZOR X™ Stealth™ Edition and StealthStation™ System).
• Nature of "Performance Testing": The document briefly lists categories of testing:
  • Navigation Accuracy Analysis
  • CAD Model Verification
  • Tools Package Functional Verification
  • NAV Simulated Use
  • Anatomical Simulated Use
• Purpose of Testing: "To ensure the functionality and compatibility of the identified Medtronic products when used with the Mazor X™ system."
• Conclusion: Based on the supporting information (which includes the performance testing), the subject instruments are deemed "substantially equivalent" to the predicate devices. This implies they met internal benchmarks/acceptance criteria, but the specific values are not provided.

In summary, the provided document is a regulatory submission summary demonstrating substantial equivalence, not a detailed technical report of the performance studies with acceptance criteria and results for the device's navigation accuracy or other functionalities.

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The Mazor X is indicated for precise positioning of surgical implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures.

Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic prom standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

The modified Mazor X hosts guidance for spine procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intra-operative planning based on Mazor X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The Mazor X enables accurate deployment of surgical accessories in the precise anatomical location according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The Mazor X is a device modification of the original Mazor X System cleared in 510(k) K182077.

This document is a 510(k) premarket notification for a medical device (Mazor X) and, as such, does not contain the detailed acceptance criteria and study data explicitly requested for the device's performance. The FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or detailed performance metrics against specific acceptance criteria.

However, based on the provided text, I can infer some aspects related to "acceptance criteria" through the lens of a 510(k) submission, mainly focusing on software and hardware validation, and the comparison to a predicate device for safety and effectiveness.

Here's a breakdown of the information that can be extracted or inferred, addressing your points where possible:

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

The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" in this context are interpreted as the successful completion and verification of specified tests confirming the device's design requirements, safety, and functionality, particularly concerning software and hardware changes.

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

The document does not specify a "sample size" in terms of number of patients, cases, or images for a test set. The validation described refers to software testing and hardware verification.

• Sample Size: Not specified for performance testing. The "test cases" for software validation are mentioned but their number is not provided.
• Data Provenance: Not applicable in the context of this 510(k) as it describes engineering verification and validation rather than clinical study data. There's no mention of country of origin or retrospective/prospective study for performance data.

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 in the document. The "ground truth" for software and hardware validation is typically defined by engineering specifications and design requirements, rather than expert clinical review.

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

Not applicable/not provided. Adjudication methods are typically used in clinical studies involving human readers, which is not the focus of the performance tests described here.

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 MRMC comparative effectiveness study is mentioned. The submission is for a device modification (software and minor hardware changes) to an existing cleared device, Mazor X System (K182077). The focus is on demonstrating that the modifications do not adversely affect safety and effectiveness and that the new device is substantially equivalent to the predicate. The device's capabilities include "precise positioning of surgical instruments or spinal implants" and "navigation tracks the position of instruments," but there are no details on improved human reader performance with or without AI assistance.

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

The document describes the device's functions (3D imaging from 2D fluoroscopic projections, instrument tracking, surgical planning). The software validation tests mentioned ("design requirements," "procedure simplicity," "performance and robustness," etc.) imply standalone algorithm performance was evaluated against its design specifications without explicit human-in-the-loop performance details in this document. However, the device itself is an assistance system for surgeons, so it inherently has a human-in-the-loop component for its intended use. The performance tests mentioned focus on the device's ability to meet its functional requirements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests described here would be the design specifications and requirements of the software and hardware. For example, for "software validation testing," the ground truth is conformance to the established design requirements. For "hardware changes verification," the ground truth is meeting the technical requirements, presumably against engineering benchmarks or validated measurements. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for these specific performance tests within this 510(k) summary.

8. The sample size for the training set

Not applicable. The document describes software validation and hardware verification of modifications to an existing device, not the development or training of a de novo AI algorithm using a separate training set.

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

Not applicable, as no training set is discussed in this regulatory document.

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