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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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Anteralign Spinal System with Titan nanoLOCK™ Surface Technology System interbody cages with macro-, micro-, and nano- roughened surface textures are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. Additionally, the Anteralign Spinal System with Titan nanoLOCK™ Surface Technology can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Anteralign Spinal System with Titan nanoLOCK™Surface Technology is intended to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a combination thereof.

The Anteralign TL Interbody must be used with a posterior supplemental internal spinal fixation cleared for use in the lumbar spine.

Miniplate and bone screw components are provided as an option for the TL interbody for the lumbosacral levels obligue or lateral above the bifurcation (12-L5) of the vascular structures, Indications of spinal instrumentation systems should be understood by the surgeon

The Anteralian Spinal System with Titan nanoLOCK™ Surface Technology TL interbody may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach.

The Arteralian™ LS interbody cage as a stand-alone device or in conjunction with supplemental fixation. The Anteralian LS™ interbody fusion Device may be inserted via minimally invasive or open anterior or oblique approach at one or two contiguous levels from L2 to S1. These approaches include anterior and oblique. When used as a stand-alone device, the Anteralign™ LS cage must be used with 3 screws with devices that have standard lordosis (≤16 degrees). If the physician chooses to use less than 3 screws or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation) must be used. Additionally, cages with lordosis angles greater than 16° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation)

The Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology consists of TL and LS interbody cages, mini plates, and bone screws.

Anteralign™ Spinal System TL and LS interbody cages are additive manufactured titanium cages available in various heights, widths, lengths, and lordotic angles to accommodate patient anatomy. The TL cage is rectangular shaped whereas the LS cage is oval shaped. The interbodies are inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The interbodies have a central cavity that allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The Anteralign™ Spinal System TL interbody cages are provided sterile and are intended to be used with supplemental fixation cleared for use in lumbar spine (L2-S1).

The TL interbody may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. Mini plates and screws are provided as options for antimigration of the Anteralign TL interbody. The miniplate is additively manufactured from titanium powder with a machined-wrought titanium bolt. The miniplate may be positioned either laterally or obliquely and oriented in either cephalad or caudal direction on the TL cage. The bone screw, which is manufactured from wrought titanium, is then placed through the miniplate intrinsic screw hole. Miniplates and bone screws are offered in different sizes and are provided sterile. Miniplates are only to be used with the TL interbody.

The Anteralign™ LS interbody cage may be used as a standalone device or in conjunction with supplemental fixation. When used as a standalone device, the Anteralign LS interbody cage is intended to be used with three screws and must have standard lordosis (≤16 degrees). The Anteralign™ LS interbody cage is intended to be used in the lumbar sacral region between L2 and S1 and may be implanted via open or minimally invasive procedures for OLIF 51 or ALIF approaches.

The interbody designs incorporate honeycomb windows and an open void to allow bone growth through the implant. The interbody device is treated with Titan Surface Technology, where Titan nanoLOCK™ Surface Technology (MMN) is designed to improve fixation to the adjacent bone. The Titan nanoLOCK™ Surface Technology provides a microscopicroughened surface with nano-scale features. The Titan nanoLOCK™ Surface Technology is specifically engineered to have nano-textured features at a nanometer (10-9) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. The Titan nanoLOCK™ Surface Technology demonstrates the elements to be considered a Nanotechnology as outlined in the FDA Nanotechnology Guidance.

Stainless steel and titanium implants are not compatible. They must not be used together in a construct.

The provided text is a 510(k) summary for the Medtronic Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology. This document is a premarket notification to the FDA for a medical device and primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than an in-depth study proving the device meets specific performance acceptance criteria for capabilities like AI assistance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, study details (like sample size, number of experts, adjudication methods for ground truth, MRMC studies, standalone AI performance), and training set details for AI-related performance cannot be extracted from this document, as this device is a physical intervertebral body fusion device and not an AI-powered diagnostic or assistive tool.

The document discusses mechanical testing to demonstrate the device's equivalent strength and performance to predicate devices, which is a different type of "performance data" than what would be generated for an AI/software device.

Here's what can be extracted and what cannot:

Information that CANNOT be extracted from this document:

• A table of acceptance criteria and reported device performance related to AI/software.
• Sample sizes used for a test set (in the context of AI/software performance).
• Data provenance for AI/software test sets.
• Number of experts used to establish ground truth for AI/software.
• Qualifications of those experts.
• Adjudication method for AI/software test sets.
• If an MRMC comparative effectiveness study was done for AI/software performance.
• Effect size of how much human readers improve with AI vs. without AI assistance.
• If a standalone (algorithm only without human-in-the-loop performance) study was done for AI/software.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) in the context of AI/software.
• The sample size for the training set (for AI/software).
• How the ground truth for the training set was established (for AI/software).

Information that CAN be inferred or extracted about the device's acceptance/testing (though not AI-related):

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

• Acceptance Criteria (Implied): The mechanical strength of the subject device (Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology) must be equivalent to that of the identified predicate devices. This is a comparison for "substantial equivalence" as required for 510(k) clearance.
• Reported Device Performance:
  • "This evaluation has demonstrated that the subject devices have equivalent mechanical strength in comparison to the predicate devices."
  • The testing was performed according to industry standards:
    • ASTM F2052
    • ASTM F2077
    • ASTM F2119
    • ASTM F2182
    • ASTM F2213
    • ASTM F2267
    • Expulsion Testing

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

• This document does not specify sample sizes for mechanical testing. It states that "Medtronic completed mechanical testing on the devices." The provenance of "data" is simply the mechanical tests conducted on the physical device. This is not a clinical study involving human patients or retrospective/prospective data collection in the sense of AI/software performance.

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

• Not applicable in the context of mechanical testing for a physical implant. The "ground truth" for mechanical testing is established by the specifications defined in the ASTM standards.

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

• Not applicable. This is not a human-reader or diagnostic study.

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 device is a physical implant, not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• For mechanical testing, the "ground truth" is typically defined by the test parameters and acceptance limits set by the applicable ASTM standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device that undergoes training.

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

• Not applicable.

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