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The Cimplicity Spinal Fixation System 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 herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Cimplicity system is a rectangular interbody fusion device. The device is hollow and may be filled with graft material. Various sizes are provided to accommodate patient anatomy. Cimplicity is made from PEEK and has tantalum beads used for radiographic visualization.

This is a 510(k) premarket notification for an interbody fusion device, not a self-calibrating diagnostic device with acceptance criteria that would typically be evaluated through a clinical study with detailed performance metrics. The information provided describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on mechanical properties and material composition rather than diagnostic performance.

Therefore, many of the requested categories are not applicable to this type of submission. I will address the relevant points based on the provided text.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the context of this 510(k) submission for an interbody fusion device. The acceptance criteria for such a device primarily revolve around demonstrating substantial equivalence to a predicate device in terms of:

• Intended Use: The Cimplicity system's intended use is for anterior cervical interbody fusion procedures, which is consistent with the predicate.
• Mechanical Properties: The submission states that the Cimplicity Spinal System was tested and compared to predicate devices for mechanical properties. While specific numerical acceptance criteria and reported performance metrics are not detailed in this summary, the FDA's clearance implies these tests were satisfactory.
• Material Composition: Cimplicity is made from PEEK and has tantalum beads, which again, was found to be substantially equivalent to predicate devices.

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

This is not applicable in the context of a clinical performance study for an AI/diagnostic device. The "test set" for this device would refer to the mechanical and material testing conducted. The document does not specify the sample size for these engineering tests or the origin of any "data" in a diagnostic sense.

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

This is not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic performance studies. For an interbody fusion device, the "ground truth" relates to engineering standards and biocompatibility, which are assessed through laboratory testing and material analysis, not expert consensus on medical images or patient outcomes in a study setup.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies among expert readers.

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

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic algorithms or imaging techniques and how they impact human reader performance. This submission is for an implantable medical device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This is not applicable. This refers to the standalone performance of an AI algorithm, which is not relevant for an interbody fusion device.

7. Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence determination would be based on:

• Engineering Test Standards: Mechanical properties (e.g., strength, fatigue) compared against established standards for spinal implants and/or predicate devices.
• Material Specifications: Verification that the PEEK material meets biocompatibility standards and that the tantalum markers are appropriate for radiographic visualization.
• Predicate Device Characteristics: Comparison to the known characteristics and performance of the legally marketed predicate devices.

8. Sample Size for the Training Set

This is not applicable. "Training set" is a term used in machine learning for AI algorithm development. This 510(k) is not for an AI device.

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

This is not applicable for the same reasons as point 8.

Summary of the Study (as described in the 510(k) Summary):

The "study" undertaken for the Cimplicity Spinal Fixation System was a substantial equivalence comparison to predicate devices. The submission states:

• "The Cimplicity Spinal System was tested and compared to predicate devices and found to be substantially equivalent in terms of intended use, mechanical properties and material composition."

This indicates that engineering and material testing were performed to demonstrate that the Cimplicity device performs as safely and effectively as existing legally marketed devices, primarily the Affinity Cervical Cage (P000028) and others. The focus of this type of submission is to ensure that the new device does not raise new questions of safety or effectiveness.

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