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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 PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with hemiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft. The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK Optima and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

The provided text is a 510(k) premarket notification for a medical device, the PEEK PREVAIL™ Cervical Interbody Device. It primarily focuses on demonstrating substantial equivalence to previously approved devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics. As such, much of the requested information regarding acceptance criteria, study design, and performance statistics is not available in the provided document.

Here's an analysis of what information can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. 510(k) submissions for devices like interbody fusion devices often rely on demonstrating substantial equivalence to predicate devices through material properties, design features, and possibly biomechanical testing, rather than clinical trials with explicit acceptance criteria for diagnostic accuracy or clinical outcomes in the same way an AI/software device would. The document does not specify any performance metrics or acceptance criteria for the PEEK PREVAIL™ device itself.

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

This information is not applicable/not provided in the context of this 510(k) submission. This document describes a physical medical device (an intervertebral body fusion device) and not a software algorithm that would typically have a "test set" in the sense of AI/ML evaluation. The submission relies on establishing substantial equivalence to existing devices through design, materials, and intended use, rather than a clinical study requiring test sets of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not provided. Ground truth establishment by experts is a concept relevant to evaluating diagnostic devices or AI algorithms. For this physical interbody fusion device, "ground truth" in the AI sense is not relevant.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are used in studies involving expert review, typically for diagnostic accuracy or outcome assessment in clinical trials or AI performance evaluations, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable/not provided. MRMC studies are typically used for evaluating the effectiveness of diagnostic imaging devices or AI tools, often comparing human reader performance with and without AI assistance. This document does not describe such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided. This document pertains to a physical medical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided. For a physical implant, "ground truth" as it relates to expert consensus, pathology, or outcomes data in the context of device performance claims isn't specified in this substantial equivalence document. Clinical outcomes for such devices are typically established through post-market surveillance or larger clinical trials that are beyond the scope of a 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable/not provided. Training sets are relevant for machine learning algorithms. The PEEK PREVAIL™ Cervical Interbody Device is a physical implant.

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

This information is not applicable/not provided. As above, this concept applies to AI/ML development, not the submission for a physical interbody fusion device.

Summary of Device and 510(k) Submission:

The provided document (K073285) is a 510(k) premarket notification for the PEEK PREVAIL™ Cervical Interbody Device.

• Device Description: An intervertebral body fusion device with internal screw fixation, "I-Beam" shaped, made from PEEK Optima with tantalum radiopaque markers and a Nitinol screw locking mechanism. It's intended to be radiolucent and used with autograft.
• Indications for Use: Anterior cervical interbody fusion in skeletally mature patients with cervical disc disease at one level (C2-C3 to C7-T1), defined by intractable radiculopathy/myelopathy with herniated disc/osteophyte formation causing nerve root/spinal cord compression. Must be used with ZEPHIR® Anterior Cervical Screws and autograft, implanted via an open, anterior approach, after six weeks of non-operative treatment.
• Substantial Equivalence: The submission demonstrates substantial equivalence to previously approved devices, including the AFFINITY® Anterior Cervical Cage, BAK/C® Cervical Interbody Fusion System, VERTE-STACK® Spinal System, and VENTURE™ Anterior Cervical Plate System. This is the primary method of approval for this device, emphasizing similarity in materials, design, and intended use to already cleared predicate devices.

Conclusion:

The provided 510(k) submission document for the PEEK PREVAIL™ Cervical Interbody Device focuses on demonstrating substantial equivalence to already approved predicate devices. It does not contain information about acceptance criteria, specific performance metrics, or study designs involving test sets, ground truth establishment, or human reader performance comparisons, as typically requested for AI/ML or diagnostic imaging device evaluations.

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