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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 Valeo™ Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Valeo™ Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Valeo™ Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Valeo™ Cervical Plate System is manufactured from wrought Ti-6A1-4V in accordance with ISO 5832-3.

The provided text describes a medical device, the "Valeo™ Cervical Plate System," and its 510(k) clearance by the FDA. However, it does not contain information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, or direct performance metrics for the device itself.

Instead, the document states:

• Performance Standards: "Testing performed on this device indicates that the Valeo™ Cervical Plate System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met."

This indicates that the device's substantial equivalence was established by demonstrating adherence to a recognized ASTM standard (F1717) and by comparison to existing predicate devices, rather than through a clinical study that measures specific acceptance criteria against reported device performance, as would be expected for an AI/CADe device.

Therefore, I cannot fulfill your request for the specific details outlined (points 1-9) because the provided text does not contain that type of information for this device submission. The device is a physical spinal fixation system, not an AI/CADe system, and its clearance relies on substantial equivalence and adherence to engineering standards for medical implants.

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