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Atlantis™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Divergence™ Anterior Cervical Fusion System: The Divergence™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. Plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2) trauma (including fractures); 3) tumors; 4) deformity (defined as kyphosis, lordosis, or scoliosis); 5) pseudoarthrosis; and/or 6) failed previous fusions. The Divergence™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non operative treatment. The Divergence™ cage must be used with supplemental fixation. The Divergence™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach. When used together, the Divergence™ components can be used only to treat cervical disc disease.

Divergence™ Anterior Cervical Fusion System (Stand-Alone Interbody): The Divergence™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Divergence™ stand-alone cervical interbody device must be used with internal screw fixation. The Divergence™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Premier™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Venture™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only.

Zephir™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Zevo™ Anterior Cervical Plate System: The Zevo™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Medtronic Anterior Cervical Plate Systems consist of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates) and screws. The Medtronic Anterior Cervical Fusion System consist of variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates), interbody cages, and screws. Fixation is provided by bone screws and/or interbody cages inserted into the vertebral body of the cervical spine using an anterior approach. The Medtronic Anterior Cervical Plate and Fusion Systems implant components are made from titanium alloy, with certain plates having subcomponents manufactured from shape memory alloys (Nitinol-NiTi). The sole purpose for this submission is to update the labeling for the Medtronic Anterior Cervical Plate and Fusion Systems to include MRI safety information while also providing MRI technologists with a method of concluding whether a MRI scan can be performed and specific instructions on how to perform the scan.

The provided document is a 510(k) summary for Medtronic Anterior Cervical Plate Systems, and it details the premarket notification to the FDA for updates to the labeling of these devices to include MRI safety information.

This document describes a medical device submission for a spinal implant, NOT an AI/Machine Learning-based diagnostic device. Therefore, the requested information regarding acceptance criteria, study details for AI performance (like sample size, number of experts, ground truth, MRMC studies, training set details), is not applicable to this document.

The "Performance Data" section specifically states:
"The following performance data were provided in support of substantial equivalence.
MR Safety Testing
In accordance with the FDA Guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment' the subject Medtronic Anterior Cervical Plate Systems were evaluated for MR-safety in accordance with the following standards:

• ASTM F2052– “Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment”
• ASTM F2213– “Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment”
• ASTM F2119– “Standard test method for evaluation of MR image artifacts from passive implants”
• ASTM F2182– “Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging”"

This clearly indicates a focus on physical and electromagnetic compatibility testing for a medical implant, not on the performance of a software or AI algorithm.

Therefore, I cannot extract the information you requested about acceptance criteria and study data for an AI/machine learning device from this document. The document concerns the physical performance and safety of a spinal implant in an MRI environment.

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The ZEPHIR™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

The ZEPHIR™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.

The provided text is a 510(k) summary for the ZEPHIR™ Anterior Cervical Plate System, a medical device. It details the device's identification, intended use, and claims of substantial equivalence to previously marketed devices. However, the document does not contain information about acceptance criteria or a specific study designed to prove the device meets such criteria in terms of analytical or clinical performance.

Instead, the submission primarily focuses on mechanical test data being provided to support the notification for substantial equivalence. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering performance testing (e.g., strength, fatigue) rather than clinical studies with human participants.

Therefore, I cannot complete the requested tables and descriptions as the information is not present in the provided text.

Specifically, the following points from your request cannot be addressed based on the provided document:

• A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy) for clinical or analytical performance, nor does it report such performance values.
• Sample sized used for the test set and the data provenance: No information about a "test set" for clinical evaluation is provided. The "mechanical test data" mentioned likely refers to engineering tests, not clinical data from patients.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no mention of a test set requiring expert ground truth.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as there's no mention of a "training set" in the context of an AI/algorithm.
• How the ground truth for the training set was established: Not applicable.

The 510(k) summary states: "Mechanical test data were provided in support of this notification." This indicates that the primary evidence for substantial equivalence for this type of device (a spinal implant) typically comes from engineering and biomechanical testing, rather than clinical studies demonstrating diagnostic accuracy or efficacy in the way an AI diagnostic tool would.

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