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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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CAPSTONE™ SPINAL SYSTEM
The CAPSTONE™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

CLYDESDALE PTC™ SPINAL SYSTEM
The CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

CRESCENT™ SPINAL SYSTEM
The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature of nonoperative treatment. These implants are to be used autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

CRESCENT™ SPINAL SYSTEM TITANIUM
The CRESCENT Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medronic supplemental fixation which has been cleared by the FDA for use in the lumbar spine.

DIVERGENCE-L™ ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Anterior Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The DIVERGENCEL™ Anterior/ Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The Intervertebral Body Fusion Device Systems are intended for vertebral body fixation of the thoracic or lumbar spine during the development of a thoracic or lumbar spinal fusion. Lumbar interbody fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

This document [K191788](https://510k.innolitics.com/search/K191788) is a 510(k) premarket notification for Medtronic Intervertebral Body Fusion Device Systems (specifically, the CAPSTONE™ Spinal System, CLYDESDALE PTC™ Spinal System, CRESCENT™ Spinal System, CRESCENT™ Spinal System Titanium, and DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System).

The submission is primarily focused on an MRI Update for these existing devices, meaning the purpose is to provide data demonstrating their safety and compatibility within the Magnetic Resonance (MR) environment. This is a common type of submission for established medical devices when new safety information or a change in labeling regarding MR compatibility needs to be supported.

Based on the provided text, there is no AI/ML component to this specific submission. The "device" in question refers to intervertebral body fusion implants, which are passive mechanical implants, not software algorithms or AI-driven systems. Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML device is not applicable to this document.

Here's a breakdown based on the information provided, highlighting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM F2052 (measurement of magnetically induced displacement force)
• ASTM F2213 (measurement of magnetically induced torque)
• ASTM F2119 (evaluation of MR image artifacts)
• ASTM F2182 (measurement of radio frequency induced heating)

The Medtronic Intervertebral Body Fusion Device Systems have been labeled in accordance with ASTM F2503 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." |
| No significant adverse interactions, displacement, torque, heating, or artifacts beyond specified limits during MRI. | (Implicitly met as the conclusion states the devices are "as safe and effective" as predicates and are labeled for MR safety.) Specific quantitative performance data from these tests (e.g., exact displacement forces, temperature increases, artifact sizes) are not provided in this summary document, but would have been included in the full submission. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable (N/A) for an AI/ML test set.
• The performance data provided is for MR safety testing of physical implants, not an AI/ML algorithm. The "test set" would consist of the physical devices themselves and the materials they are made from, subjected to various MR field conditions in a lab environment.
• Data provenance is typically from controlled laboratory testing environments, not patient data in the context of AI/ML.

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

• Not Applicable (N/A). This is a question relevant to AI/ML model evaluation involving human expert interpretation. For physical device MR safety testing, ground truth is established by physical measurements and compliance with ASTM standards, not expert consensus on interpretations.

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

• Not Applicable (N/A). Adjudication methods are for human interpretation of data, often in AI/ML performance studies. MR safety testing involves physical measurements and engineering evaluations.

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 (N/A). There is no AI/ML component or human-in-the-loop scenario described in this submission. This is a K-number for physical intervertebral body fusion devices and their MR compatibility, not an AI/ML software.

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

• Not Applicable (N/A). This document concerns physical intervertebral body fusion implants, not a standalone AI/ML algorithm.

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

• Not Applicable (N/A) in the context of AI/ML.
• For the MR safety testing, the "ground truth" (or reference standard) is defined by the ASTM test methods and their specified thresholds/parameters. For example, a certain level of magnetically induced displacement is acceptable, and exceeding that is considered unsafe.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML algorithm in this submission, and therefore no training set.

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

• Not Applicable (N/A). There is no AI/ML algorithm or training set discussed in this document.

Summary of Document K191788:

This 510(k) premarket notification is for intervertebral body fusion device systems (implants used in spinal surgery). The core of this particular submission is an MRI Update, which means the manufacturer is providing data to demonstrate the safety and compatibility of these existing physical implants when subjected to Magnetic Resonance (MR) imaging environments. The document details the various predicate devices and the indications for use of the Medtronic systems. The "performance data" section explicitly lists MR safety testing conducted according to recognized ASTM standards. The conclusion states that based on this data, the devices are "as safe and effective as the following predicates" and have been appropriately labeled for MR safety. The document does not involve any artificial intelligence, machine learning, or software algorithm performance evaluation.

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The CD HORIZON™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON™ Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, the CD HORIZON™ LEGACY™ 3.5mm rods and the CD HORIZON™ Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON™ Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEXT™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

The CD HORIZON™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.

A subset of CD HORIZON™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK™ Plates and connecting components. Similarly, to the CD HORIZON™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The purpose of this Special 510(k) is to add additional components to the Medtronic's CD HORIZON™ Spinal System. The devices being added are sterile domino connectors made using Titanium Alloy.

This document is a 510(k) premarket notification for the Medtronic Sofamor Danek CD HORIZON™ Spinal System, specifically for the addition of sterile domino connectors made of Titanium Alloy. It is not an AI/ML device, therefore, the requested information type cannot be extracted.

This document describes the safety and performance testing for a medical device (CD HORIZON™ Spinal System) and does not involve AI/ML. Therefore, I cannot extract information related to AI/ML device performance, such as:

• Acceptance criteria and reported device performance for an AI/ML device
• Sample size and data provenance for an AI/ML test set
• Number and qualifications of experts for AI/ML ground truth
• Adjudication method for AI/ML
• MRMC comparative effectiveness study for AI/ML improvement
• Standalone AI/ML performance
• Type of ground truth for AI/ML
• Sample size and ground truth establishment for AI/ML training set

The document primarily focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and mechanical testing, which are standard for traditional medical implants. The key takeaway from the performance data section is that non-clinical mechanical testing was not performed on the sterile implants because they are "identical to the predicate devices in terms of material, rod compatibility sizes, rod interconnection features, intended use and indications for use." The predicate devices were tested according to ASTM F1798 and F1717, and this is deemed sufficient for the new components.

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