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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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The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate. These implants are intended for use with supplemental internal fixation systems.

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 Catalyft™ PL Expandable Interbody System consists of implants, instruments, and cases, trays, and lids. The subject implants are expandable lordotic Titanium Alloy (Ti-6Al-4V ELI) interbody fusion implants that are provided in either an inline straight tip, known as the “PL” implant, or a hockey stick-shaped tip, which is known as the “PL40” implant. The implants are expandable and have varying footprints, heights, and lengths that provide surgeons the ability to have better control of the restoration of lordosis in patients and allows more ability to appropriately size the interbody to match patient anatomy. The subject implants are designed with a hollow center region to house autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. In addition to implants, navigated instruments compatible with the StealthStation™ system have been developed. The subject StealthStation™ System compatible instruments are specific to the subject implants, and there are no changes to the StealthStation™ software related to the stereotaxic instruments in this submission. Previously cleared Navigated Rotating Shavers (K150231, S.E. 06/16/2015, K163581, S.E. 04/14/2017; K201267, S.E. 08/26/2020) will be used as disc prep instruments and trials for the Catalyft™ PL system. Cases, trays, and lids have been developed for transportation of the subject instruments.

This document describes the Catalyft™ PL Expandable Interbody System and Navigated Instruments Compatible with StealthStation™ System. The document does not contain information about an AI/ML device. Therefore, it is not possible to describe acceptance criteria and associated studies for an AI/ML device based on this document.

The document discusses the substantial equivalence of the Catalyft™ PL Expandable Interbody System and its navigated instruments to predicate devices. It mentions performance data related to mechanical testing of the implants and verification/validation testing for the navigated instruments.

Here's a breakdown of the type of information presented, which is relevant for a medical device but not an AI/ML system:

• Acceptance Criteria & Device Performance: The document lists various ASTM standards (ASTM 2077, ASTM 2267, ASTM Draft Standard F-04.25.02.02) for mechanical testing (Compression Fatigue, Compression-Shear Fatigue, Static Compression, Static Compression-Shear, Subsidence, Expulsion) of the implants. It also states that testing was completed to ensure the functionality and compatibility of new/existing instruments, and that navigated instruments underwent verification and validation activities. However, specific acceptance criteria values or detailed performance results are not provided in this summary.

• Sample Size, Data Provenance, Ground Truth for Test Set, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type (for Test Set), Training Set Sample Size, and Ground Truth for Training Set: These categories are typically associated with the evaluation of AI/ML algorithms and are not applicable to the information provided in this document, as it concerns a physical medical device and its instruments. The focus is on mechanical integrity and functional compatibility rather than algorithmic performance or diagnostic accuracy.

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