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The Mazor X is indicated for precise positioning of surgical instruments or spinal 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 projections from standard C-arms into a 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 Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. Same as the predicate device the modified Mazor X consists of a workstation with dedicated software, the surgical system, navigation camera, accessories, instruments and disposable kits. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the Mazor X System cleared in 510(k) K230064.

This 510(k) clearance letter describes a device, the Mazor X System / Mazor X Stealth Edition, and its substantial equivalence to a predicate device. It includes detailed information about new AI-enabled features: "2D Automatic Measurements" and "Plan Assist." The following analysis focuses on the acceptance criteria and study details for these AI components as presented in the provided text.

Acceptance Criteria and Reported Device Performance

Device: Mazor X System / Mazor X Stealth Edition (Software enhancements for 2D Automatic Measurements and Plan Assist)

Detailed Study Information for AI-enabled Features

1. 2D Automatic Measurements (AI-enabled Feature)

• Sample Size for Test Set:
  • Clinical Evaluation: 146 AP images, 253 LAT images (for all spinopelvic parameters). Each specific spinopelvic parameter had its own sample size ranging from 24 to 126 images.
• Data Provenance for Test Set: Not explicitly stated (e.g., country of origin). The note about "U.S. certified spine surgeons and radiologists" for reference standard implies some U.S. involvement, but doesn't specify data origin. It is explicitly stated that these datasets were independent from the development dataset, with data source site-level separation to ensure data independence.
• Number of Experts for Ground Truth (Test Set): Three U.S. board-certified radiologists.
• Qualifications of Experts (Test Set): U.S. board-certified radiologists. (No years of experience provided).
• Adjudication Method (Test Set): Not explicitly stated, but implies individual evaluation by the three radiologists and comparison to AI measurements.
• MRMC Comparative Effectiveness Study: No, a standalone performance of the AI algorithm was evaluated against expert annotations.
• Standalone Performance: Yes, the accuracy of the endplate and femoral heads detection algorithms, and the accuracy of 13 spinopelvic parameters' measurements were evaluated.
• Type of Ground Truth (Test Set): Expert annotations/measurements. Each spinopelvic parameter's ground truth was comprised of annotations (endplate lines, endplate endpoints, and/or femoral head circles) performed by the three U.S. board-certified radiologists using the Mazor X device.
• Sample Size for Training Set:
  • Endplate Detection: 2327 AP images, 2651 LAT images.
  • Femoral Heads Detection: 2233 LAT images.
• How Ground Truth for Training Set was Established: Endplate line and Circle femoral heads annotations were performed by trained labelers within a quality-controlled environment. In case of multiple annotations, they were aggregated. More than 65% of the data was reviewed by U.S. certified spine surgeons and radiologists.

2. Plan Assist (AI-enabled Feature)

• Sample Size for Test Set: 326 screw plans from 25 spine images.
• Data Provenance for Test Set: Not explicitly stated (e.g., country of origin). It is explicitly stated that these datasets were separated at the site level from the development dataset to ensure data independence.
• Number of Experts for Ground Truth (Test Set): Three experts.
• Qualifications of Experts (Test Set): Not explicitly stated, but are referred to as "experts" who evaluated clinical acceptability.
• Adjudication Method (Test Set): Each AI-generated screw plan was evaluated by three experts for clinical acceptability.
• MRMC Comparative Effectiveness Study: No, a standalone performance of the AI algorithm was evaluated against expert judgment of clinical acceptability.
• Standalone Performance: Yes, the clinical acceptability of AI-generated screw positions was evaluated.
• Type of Ground Truth (Test Set): Expert judgment of clinical acceptability.
• Sample Size for Training Set: 160 studies (101 3D CT scans, 59 3D O-arm scans), 942 vertebrae, 5,795 unique screw placements, and over 23,000 screw plannings.
• How Ground Truth for Training Set was Established: Annotations for pedicle screw planning (referred to as "reference Screw planning") were manually performed by 34 qualified Surgical support technicians using a released Mazor X software.

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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 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 IPCT™ 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.

The CD HORIZON™ Spinal System surgical instruments are non-sterile or sterile, single, or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD Horizon™ instruments are intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connection site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the Mazor X Stealth™ Edition, the instrument dimensions have been designed to work with the Mazor X arm guides. The subject RG FAS Drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The subject instruments are reusable and will be provided non-sterile.

The provided text is a 510(k) summary for a medical device (Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition) and does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets such criteria.

The document discusses:

• Device Name: CD Horizon™ Spinal System / Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition
• Regulatory Information: 510(k) clearance, product codes, classification, predicate devices.
• Intended Use: Surgical instruments for preparing and placing Medtronic implants during spinal surgery, assisting in precisely locating anatomical structures, compatible with MAZOR X Stealth™ Edition.
• Technological Characteristics: Comparison with predicate devices, stating similar intended use, indications, material, fundamental technology, and sterilization method.
• Performance Data: This section briefly mentions verification/validation activities, but these are for the surgical instruments themselves and their compatibility with the navigation system, not for an AI/ML algorithm's performance. The activities listed are:
  • Design Validation and Anatomical Simulated Use
  • Navigation Simulated Use
  • Navigation Accuracy Analysis

Given this, I cannot provide the requested information about acceptance criteria and the study that proves an AI/ML device meets them because the provided text does not describe an AI/ML device or its evaluation. It focuses on traditional surgical instruments.

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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 Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

The CD HORIZON™ Spinal System surgical instruments are non-sterile, single or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD Horizon™ instruments are intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connect ion site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work with the MAZOR X arm guides. The subject taps and drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011). The instruments will be provided non-sterile and are reusable.

The provided document is a 510(k) summary for the Medtronic CD Horizon Spinal System. It does not include information about a study proving the device meets specific acceptance criteria in the way a clinical study would for an AI/algorithm-driven medical device.

This document describes a new version of surgical instruments, designed to be compatible with existing navigation and robotic systems (MAZOR X Stealth™ Edition, IPC™ POWEREASE™ System, and NavLock™ trackers). The "performance data" section refers to engineering verification testing rather than a clinical study evaluating diagnostic or therapeutic accuracy against human performance. The device itself is a set of surgical instruments, not an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, sample size, expert ground truth, MRMC study, standalone performance, etc.) from this document because it is not relevant to the type of device and study requested in the prompt.

The "Performance Data" table provided in the document refers to engineering and functional testing of the instruments, such as:

• Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
• Anatomical Simulated Use: Confirmed instrument functionality under expected use conditions.
• Navigation Simulated Use: Confirmed navigation system functionality under expected use conditions.
• CAD Model Evaluation: Verified that the CAD models are accurately reflected in the application software.
• Navigation Software Module Instrument Functional Testing: Verified that the instrument attributes are correctly implemented in the navigation software module.

These are design verification and validation activities for a physical instrument, not a study evaluating the performance of an AI algorithm or a diagnostic tool against human ground truth.

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The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with Medtronic systems utilizing STEALTH™ Technology. The NavLock™ Trackers should only be used with Medtronic instruments on Medtronic systems utilizing STEALTH™ Technology.

The NavLock™ Trackers are compatible with StealthStation™ Systems and Mazor X STEALTH™ Edition and are used in conjunction with various navigated spine instrumentation for optical navigation. To enable navigation compatibility, the proximal ends of the instruments are designed to fit into the NavLock™ Trackers for optical navigation. The NavLock™ Trackers have posts to affix reflective spheres, which are visible to the StealthStation camera as a means of tracking the position of the attached surgical instrument.

The provided text describes a 510(k) premarket notification for Medtronic Navigation's NavLock Trackers. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel study to determine acceptance criteria and device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable or not provided in the given document.

However, based on the information available, here's a reconstructed answer:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text for the current submission (K201327). The document indicates "worst-case test configurations" were used in previous clearances (K182104 and K171267).
• Data Provenance: The document does not specify the country of origin. The previous studies were "system-level accuracy testing." It's retrospective in the sense that the current submission relies on previous clearances and states "There have been no significant design changes to the NavLock™ Trackers since clearance in K182104. Therefore, performance testing is not needed to demonstrate substantial equivalence in the current submission."

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

• Not applicable/Not provided. The performance testing was for device accuracy (positional and trajectory error), which typically relies on metrological measurements rather than expert human interpretation to establish ground truth.

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

• Not applicable/Not provided. Adjudication is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this device's accuracy testing.

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 is a medical device (trackers for navigation systems), not an AI diagnostic algorithm that assists human readers.

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

• The performance testing cited (positional and trajectory error) represents the "standalone" accuracy of the navigation system when using the trackers. The device itself (NavLock Trackers) is a component of a navigation system, and its performance contributes to the overall system's accuracy. The stated accuracies (≤2.0 mm positional error and ≤2.0° trajectory error) can be considered the standalone performance based on the system's measurements.

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

• For the accuracy testing, the ground truth would have been established by precise measurement systems (e.g., optical metrology systems) used to determine the true position and trajectory, against which the device's measurements were compared. The text mentions "system level accuracy testing."

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on its physical design and optical tracking principles.

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

• Not applicable, as there is no training set for this device.

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