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The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios, and degenerative disease of the facets with instability.

The PERLA® posterior cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

The Spineart Perla® system is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and the upper thoracic spine. Perla® system consists of a variety of shapes and sizes of rods, hooks, multi-axial screws, set screws, rod connectors and transverse connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The Perla® system can also be linked to the cleared Spineart Romeo®2 spinal system (K151695) using the specific Perla® Axial and Parallel Rod to Rod connectors 3.5/5.4mm or the Perla® Transition Rods 3.5/5.4mm which are part of this submission.

The provided document is a 510(k) summary for the PERLA® Posterior Cervico-Thoracic Fixation System. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

The information provided describes a traditional medical device (implantable fixation system for spinal segments) and its FDA clearance process. It does not involve AI or algorithms, and therefore, the requested information about AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable or present in this document.

Therefore, the table below will be filled with "Not Applicable" or "Information Not Provided" as the document pertains to a physical medical device and not an AI/ML system.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Information Not Provided (Not applicable to a physical spinal fixation system)
• Data Provenance: Information Not Provided (Not applicable to a physical spinal fixation system)

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

• Number of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)
• Qualifications of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)

4. Adjudication method for the test set

• Adjudication Method: Information Not Provided (Not applicable to a physical spinal fixation system)

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

• MRMC Study Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML system for image interpretation or diagnosis by human readers.)
• Effect Size: Not Applicable

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

• Standalone Study Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML algorithm.)

7. The type of ground truth used

• Type of Ground Truth: Information Not Provided (Not applicable to a physical spinal fixation system. For this device, "ground truth" would refer to manufacturing specifications, material properties, and mechanical testing results, which are detailed in the document but not in the context of diagnostic "ground truth" for AI.)

8. The sample size for the training set

• Training Set Sample Size: Information Not Provided (Not applicable to a physical spinal fixation system)

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

• Ground Truth Establishment: Information Not Provided (Not applicable to a physical spinal fixation system)

Summary of Device Performance (from the document, relevant to a physical device):

The document states that "Published literature and bench testing per ASTM F1717 demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to the predicate devices."

The following non-clinical tests were conducted:

• Static Compression Bending, Static Torsion, and Dynamic Compression Bending according to ASTM F1717.
• Static flexion-extension testing, Static axial gripping, and Static torsion gripping according to ASTM F1798.
• Axial pullout strength and Torque to failure according to ASTM F543.

The conclusion is that "Design comparisons and non-clinical performance testing demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function."

These tests and their results are used to establish substantial equivalence for a traditional spinal implant, not to evaluate the performance of an AI/ML algorithm against predefined acceptance criteria for diagnostic accuracy or similar metrics.

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The VERTEX® Reconstruction System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative diseaseof the facets with instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use

The VERTEX® Reconstruction System is a posterior system which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. Conditions of the cervical spine, such as degenerative disc disease, tumor, or trauma, can lead to instability and pain for patients. In order to treat the instability, surgeons may need to use implants to reconstruct the spine. The VERTEX® Reconstruction System is a comprehensive set of options that provides adjustability, flexibility, and adaptability to meet the anatomical challenges of the occipitocervical and upper thoracic spine. The VERTEX® Reconstruction System is intended to be implanted by an orthopedic surgeon as described in the Surgical Technique. Each construct is specifically designed for each individual case. The components of the VERTEX® Reconstruction System are fabricated from medical grades of commercially pure titanium (ASTM F67-13), titanium alloy (ASTM F136-13), and cobalt chromium (ASTM F1537-11). The VERTEX® Reconstruction System also includes a retaining ring for the use with the multi-axial screw which is fabricated from Shape Memory Alloy, Nitinol-NiTi (ASTM F2063-12).

The sole purpose for this submission is to update the labeling for the VERTEX® Reconstruction System to include MRI safety information while also providing MRI technologists with a method of concluding whether an MRI scan can be performed and specific instructions on how to perform the scan.

This document describes the MRI safety evaluation of the VERTEX® Reconstruction System. It does not describe an AI medical device. Therefore, it's not possible to provide acceptance criteria and study details as they would apply to an AI device.

However, I can extract the information related to the MRI safety evaluation which is the focus of this submission. This is not an AI device, so many of the requested fields (like number of experts, adjudication methods, multi-reader studies, training sets) are not applicable.

Here's a summary of the MRI safety evaluation details:

Overall Purpose of Submission: To update the labeling for the VERTEX® Reconstruction System to include MRI safety information and instructions on how to perform an MRI scan with the device.

1. Table of Acceptance Criteria and Reported Device Performance (for MRI Safety)

Conclusion from all evaluations: The VERTEX® Reconstruction System was determined to be MR-conditional.

2. Sample Size Used for the Test Set and Data Provenance:

• A comprehensive computer simulation study was used to identify worst-case configurations for RF-induced heating. The document doesn't specify a "sample size" in terms of number of different construct models but states it involved "evaluating simple models (rods, screws, hooks) and adding additional components to create a more complex model."
• "Worst-case configurations" identified from simulations were physically tested in real MR scanners (both 1.5 T and 3 T). The specific number of constructs or tests conducted is not explicitly stated as a "sample size" but implies sufficient testing to cover critical configurations.
• The provenance is from Medtronic Sofamor Danek USA, Inc.'s internal testing and simulation studies, as described in their 510(k) submission. This is a prospective evaluation for the purpose of regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• This is not applicable as the study involves engineering and physics testing against established ASTM standards for MRI safety, not interpretation of medical images or clinical outcomes by experts.

4. Adjudication Method for the Test Set:

• Not applicable for this type of engineering and physics testing. Compliance is determined by meeting the specified limits and methodologies of the ASTM standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, this is not an AI device or a diagnostic imaging aid. Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable, as this is a medical implant and its MRI safety evaluation, not a standalone algorithm. The "computer simulation study" aspect is a part of the engineering design and testing, not an AI algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" here is the established physical principles and safety limits defined by international ASTM standards regarding MRI compatibility (e.g., maximum temperature rise, acceptable displacement force, torque, and artifact levels). The physical testing confirms adherence to these standards.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not a machine learning or AI algorithm. The computer simulations are for identifying test configurations, not for training a model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as there is no training set for an AI model.

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The LEXUS Cervical Fixation System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and . radiographic studies)
• . Spondylolisthesis
• . Spinal stenosis
• . Fracture/dislocation
• . Failed previous fusion
• . ' Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, rods, set screws, and hooks.

Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.

The LEXUS Cervical Fixation System's performance was evaluated through mechanical testing according to ASTM F1717 standards, which outlines methods for static and dynamic tests of spinal implant constructs in a vertebral body model.

1. Acceptance Criteria and Reported Device Performance:

Note: The provided document states that the device was "tested according to the ASTM F1717", and that it is "considered substantially equivalent to other legally marketed devices" and "expected to be equivalent in safety and effectiveness." This implies that the device met the performance requirements specified in the ASTM F1717 standard, which serve as the acceptance criteria for mechanical performance for such spinal fixation systems. Specific numerical acceptance criteria and actual reported performance values are not detailed in this summary.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not specified in the provided document. As this is mechanical testing, the "sample size" would refer to the number of physical devices or constructs tested for each mechanical test.
• Data Provenance: The testing was conducted by or for L&K BIOMED Co., Ltd., based in the Republic of Korea. The document does not specify the location of the testing laboratory (e.g., in-house, third-party, country). This is a technical performance study, not a clinical study involving human patients.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• Not applicable. This study focuses on the mechanical performance of the device, not a diagnostic or prognostic assessment requiring expert medical opinion for ground truth.

4. Adjudication Method for Test Set:

• Not applicable. This is a mechanical engineering test, not a clinical study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a submission for a physical medical device (spinal fixation system) and its mechanical performance, not an AI or imaging-based diagnostic device. Therefore, no MRMC study was performed.

6. Standalone Performance Study:

• Yes, a standalone study was performed in the sense that the device's mechanical performance was tested independently of its clinical implantation or interaction with human readers. The tests (Static/Dynamic Axial Compression, Static Tension, Static Torsion) evaluated the device itself.

7. Type of Ground Truth Used:

• The "ground truth" for this study is defined by the objective physical and mechanical properties and behaviors of the device as measured against the industry standard (ASTM F1717). This includes parameters like strength, stiffness, and fatigue life under specified loading conditions.

8. Sample Size for Training Set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors: The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with cach construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.

The VERTEX™ Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with medical grade titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to add modified CROSSLINK® Plates and set screws to the system.

The provided text describes a 510(k) premarket notification for the VERTEX™ Reconstruction System, a spinal interlaminal fixation orthosis. It indicates FDA clearance based on substantial equivalence to previously cleared devices. However, the document does not contain any information about acceptance criteria, detailed device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them. This type of detailed performance data is typically found in the full 510(k) submission, which is not fully available in this extract. The provided text is primarily the 510(k) summary and the FDA's clearance letter, which focus on indications for use and substantial equivalence to predicates rather than detailed performance metrics.

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