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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 CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically designed for use with the Medtronic 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 long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The CORUS™ Navigation Access System is a manually operated disposable instrument set to be used with the Medtronic StealthStation™ System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The CORUS™ Navigation Access System includes the Navigated Access Chisel, Guide Tube, and Trephine Decorticator. The instruments are manufactured from stainless steel.

The provided text is a 510(k) summary for the CORUS™ Navigation Access System. It describes the device, its intended use, and its technological characteristics. However, it does not contain specific acceptance criteria, performance metrics, or detailed study results that would typically be presented in a clinical validation or performance study.

Instead, the performance data section states:

"The CORUS™ Navigation Access System has been evaluated though an engineering analysis and geometric comparison to the predicate device. A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System. The results show that the subject device is substantially equivalent to the cleared predicates."

This indicates that the manufacturer performed:

• Engineering analysis: Likely involved design reviews, material compatibility, and structural integrity assessments.
• Geometric comparison: Compared the dimensions and design of the CORUS™ system to existing, cleared predicate devices.
• Navigation compatibility validation: This would have assessed if the CORUS™ Navigation Access System correctly interfaces and functions with the Medtronic StealthStation™ System as intended.

Therefore, based only on the provided text, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9, as this information is not present. The document focuses on demonstrating substantial equivalence through engineering analysis and compatibility rather than a clinical performance study with defined criteria and metrics.

If this were a typical clinical performance study, the requested information would be available. Since it is not, the response must reflect the absence of such data in the provided document.

Summary of missing information based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "evaluated though an engineering analysis and geometric comparison" and "A validation was also conducted to demonstrate navigation compatibility," but no specific criteria or results are listed.
• 2. Sample sized used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method: Not mentioned.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. No human reader interaction is implied or detailed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "manually operated disposable instrument set" that "assists the surgeon." It is not an "algorithm only" device. The validation focused on navigation compatibility.
• 7. The type of ground truth used: Not applicable in the context of the described engineering and compatibility validations.
• 8. The sample size for the training set: Not applicable; this is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

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The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets is categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The modified Anatase Spine Surgery Navigation System, the subject of these 510(k) applications, introduces software, hardware and instruments modifications to the original Surgery Navigation System cleared in 510(k) K180523.

The Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-Spine2-V, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify sample sizes for any test sets nor the data provenance (e.g., country of origin, retrospective/prospective). The studies are non-clinical, meaning they did not involve patient 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 as these were non-clinical tests.

4. Adjudication method for the test set:

This information is not provided in the document as these were non-clinical tests.

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 clinical testing, including MRMC studies, was conducted. The document explicitly states: "No clinical testing has been conducted."

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

The provided information focuses on the entire system's performance, which is an image-guided navigation system that would inherently involve human interaction (a surgeon). While software verification and validation were performed, the document does not distinguish between human-in-the-loop and algorithm-only performance for a standalone assessment in a manner that would typically be seen for an AI diagnostic device. The "Accuracy" test implies an assessment of the system's ability to track and display positions, which is a standalone performance metric for the navigation component, but it's not described as an AI-specific algorithm performance.

7. The type of ground truth used:

For the accuracy testing, the ground truth would likely be established through precise physical measurements to determine the true positional accuracy of the system against a known standard. However, the document does not specify the exact methodology for establishing the ground truth beyond referencing ASTM F2554-18. For other tests like electrical safety, EMC, and sterilization, the "ground truth" is defined by compliance with the referenced standards.

8. The sample size for the training set:

As this is a navigation system and not explicitly an AI diagnostic device in the context of machine learning model training, the concept of a "training set" in that sense is not directly applicable or discussed in the document. Software verification and validation were performed, but details on data used for these processes are not provided.

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

Same as above, the concept of a "training set" with established ground truth as typically understood in AI/machine learning is not applicable here. Software verification and validation would use various testing methods to ensure the software performs as designed and meets requirements.

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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 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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