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The Edge upper cervical system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3):

· Traumatic spinal fractures and/or traumatic dislocations;

• · instability or deformity:
• · failed previous fusions (e.g., pseudarthrosis);
• · tumors involving the cervical/thoracic spine;

· degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· degenerative disease of the facets with instability.

The Edge UCS 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. The Edge UCS is intended for use only with the Innosys Anax™ OCT Spinal System.

The Edge UCS consists of a main body that clamps on to the posterior arch of C1 to provide fixation and stability. The Edge UCS is then connected to the Innosys Anax OCT instrumentation using polyaxial rods to form a posterior cervical construct, similar to that of the predicate devices. The Edge device is an additively manufactured clamp composed of two fixation jaws superior to the C1 posterior arch, an inferior jaw base, and two receiving joints for polyaxial rods. The Edge UCS accommodates varying patient anatomy by providing three implant sizes. The Edge UCS is additively manufactured from titanium alloy Ti6Al4V ELI and is designed with areas for bone graft to be placed on the medial and lateral bone contacting regions of the device.

The provided text describes a medical device, the "Edge Upper Cervical System," and its clearance by the FDA based on a determination of substantial equivalence to predicate devices. However, the document does not contain the information requested regarding the acceptance criteria, specific study details, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance.

The "Performance Data" section solely outlines mechanical performance tests conducted on the physical device (e.g., ASTM F1717 Static Axial Compression, ASTM F1717 Dynamic Torsion, Custom Sawbones Pull Off Test) to demonstrate its structural integrity and suitability for its intended use. These tests are not related to an AI/algorithm's performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for a test set or data provenance related to AI.
3. Number of experts and their qualifications for AI ground truth.
4. Adjudication method for an AI test set.
5. MRMC comparative effectiveness study results for AI.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI.
8. Sample size for an AI training set.
9. How ground truth for an AI training set was established.

This document is for a physical spinal implant system, not a software or AI-driven medical device.

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The BRIDALVEIL Occipital Cervical Thoracic 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 (Cl 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 radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic 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 BRIDALVEIL Occipital Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.

The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation system intended to stabilize the uppermost portion of the spine during the fusion process. The system contains a wide variety of implants and instruments which allows for the transition across multiple spinal segments: Occipital Plate with Screws, Cervical Polyaxial Screws, Laminar Hooks, Cross Connectors, Rod Connectors, and Rods manufactured from Ti6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537).

The provided text describes the regulatory clearance for the BRIDALVEIL Occipital Cervical Thoracic System, a spinal fixation system. It does not detail acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

This document is a 510(k) premarket notification for a traditional medical device (spinal fixation system), not an AI/ML device. Therefore, the details requested in the prompt, such as reported device performance, sample size for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set, are not applicable in the context of this submission.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: Providing immobilization and stabilization of spinal segments as an adjunct to fusion for various conditions (traumatic fractures/dislocations, instability, tumors, degenerative disease, etc.) in the craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3). It also mentions restoring spinal column integrity for a limited time in advanced stage tumor patients.
• Design: The system includes occipital plates with screws, cervical polyaxial screws, laminar hooks, cross connectors, rod connectors, and rods.
• Materials: Ti6Al4V ELI (ASTM F136), cobalt chrome alloy (ASTM F1537), Elgiloy CoCrNi alloy (ASTM F1058), and Nitinol #1 (ASTM E2063).
• Mechanical Safety and Performance: Evaluated through non-clinical bench testing.

Here's the information extracted from the document, framed in the context of a traditional medical device submission, rather than an AI/ML one:

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

For this traditional medical device (BRIDALVEIL Occipital Cervical Thoracic System), "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through conformity to recognized standards for mechanical performance and material properties. "Reported device performance" is derived from the results of these non-clinical tests meeting the requirements of those standards.

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

• Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical specimens of the device components tested in a laboratory setting. No human patients or retrospective/prospective data were used for performance evaluation.
• Data Provenance: The data provenance is from non-clinical bench testing conducted in a laboratory. The specific country of origin of the lab is not stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. "Ground truth" in this context refers to the defined parameters and performance standards derived from the ASTM standards for mechanical testing. These standards are established by expert committees in engineering and materials science, but individual experts are not "adjudicating" a test set as they would for clinical images or diagnoses.

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

• Not applicable. There's no human adjudication process described for the mechanical test results; rather, the results are compared against predefined criteria within the ASTM standards.

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 is not an AI/ML device, and no MRMC studies or human reader performance evaluations were conducted.

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

• Not applicable. This is not an AI/ML device. The "standalone performance" is the mechanical testing of the device itself against engineering standards.

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

• For this device, the "ground truth" (or reference for evaluation) is established through recognized industry standards for mechanical testing of spinal implants (e.g., ASTM F1717, ASTM F2706, ASTM F1798). The device's performance is compared against the requirements and typical performance of predicate devices as measured under these standardized conditions.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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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 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 disease of the 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 subject VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, screws, hooks, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® Cable may be used with this system at the surgeon's discretion.

This document describes the regulatory clearance for the VERTEX® Reconstruction System, a medical device used for spinal immobilization and stabilization. It does not contain information about studies involving AI or machine learning algorithms. Therefore, much of the requested information regarding AI study specifics cannot be extracted from this document.

However, I can provide available information related to the device's acceptance criteria and the non-clinical and retrospective clinical studies used to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria (or demonstrated equivalence) and Reported Device Performance

The document states that the VERTEX® Reconstruction System is substantially equivalent to the predicate AXIS® Fixation System. This means the acceptance criteria are not explicit performance metrics in a classical sense, but rather a demonstration that the new device performs at least as well as, and has similar technological characteristics to, the legally marketed predicate.

Regarding the device's "performance": The document does not provide specific numerical performance metrics (e.g., success rates, complication rates) for the VERTEX® Reconstruction System or the predicate device. Instead, it relies on the concept of substantial equivalence, implying that its performance is comparable to that of the pre-existing, legally marketed device.

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

• Test Set (for clinical data): The document refers to "Retrospective clinical data provided in support of this application along with the published clinical outcomes of additional patients treated with the VERTEX® device for the indications sought." The sample size for the retrospective clinical data is not specified in this document.
• Data Provenance: The available clinical data is retrospective. The country of origin is not specified but is implicitly from the locations where the VERTEX® device has been used or studied.

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

This information is not available in the provided document. As this is a medical device clearance based on substantial equivalence, the "ground truth" for clinical outcomes would typically be based on established medical evaluations, but the specific process and expert involvement are not detailed.

4. Adjudication method for the test set

This information is not available in the provided document.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device does not involve AI or human readers for diagnostic interpretation in the context of the provided regulatory submission.

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

No, a standalone algorithm study was not done as this device is a physical implantable medical device, not an algorithm.

7. The type of ground truth used

For the retrospective clinical data, the "ground truth" would implicitly be the clinical outcomes observed in patients treated with the VERTEX® device, evaluated against the accepted medical standards for spinal fusion and stabilization. However, the specific methodology for establishing this ground truth (e.g., pathology, independent outcomes assessment) is not detailed in the document.

8. The sample size for the training set

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets.

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

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets and ground truth.

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