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The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

When used as an intervertebral body fusion device, the Cimplicity 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-TI 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 non-operative treatment prior to treatment with a Cimplicity interbody fusion device.

Cimplicity is a rectangular shaped implant, which is available in a parallel or lordotic configuration of various heights. Cimplicity is hollow to allow for the placement of allograft or autograft bone. There vare teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SpineSmith Cimplicity Spinal System:

Based on the provided text (K080971), this submission is for a traditional 510(k) premarket notification for a Class II medical device, specifically a Spinal Intervertebral Body Fixation Orthosis and an Intervertebral fusion device. For such devices, "acceptance criteria" and substantiating "studies" in the context of device performance are typically demonstrated through substantial equivalence to predicate devices. This means showing that the new device is as safe and effective as a legally marketed predicate device.

The study presented here is primarily a mechanical test study comparing the proposed device to predicate devices, rather than a clinical study evaluating human performance or an AI algorithm's diagnostic capabilities. Therefore, many of the requested categories regarding AI, expert ground truth, and human reader performance are not applicable.

Acceptance Criteria and Reported Device Performance

Study Details

Given that this is a 510(k) for a spinal implant, the "study" referred to is primarily a non-clinical, benchtop mechanical testing study to demonstrate substantial equivalence, not a clinical trial or AI performance study.

1. Sample size used for the test set and the data provenance:
   This information is not provided in the document. For mechanical testing, this would typically refer to the number of devices tested for each parameter (e.g., compression, torsion, fatigue). Data provenance is also not mentioned, but it would be from internal lab testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable for a mechanical testing study. Ground truth in this context would refer to physical measurements and engineering standards, not expert medical consensus.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This is not applicable for a mechanical testing study. Mechanical test results are typically objective measurements against predefined criteria or comparison to predicate device performance.

4. 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, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For mechanical testing, the "ground truth" implicitly refers to engineering specifications, material properties, and performance benchmarks derived from predicate devices, established standards (e.g., ASTM, ISO), and biomechanical principles. It is based on objective physical measurements.

7. The sample size for the training set:
   Not applicable as this is not an AI/machine learning study.

8. How the ground truth for the training set was established:
   Not applicable as this is not an AI/machine learning study.

Summary regarding the device and its "study":

The SpineSmith Cimplicity Spinal System is a physical medical implant. Its safety and effectiveness are established through demonstrating substantial equivalence to existing predicate devices, primarily through mechanical testing. The document explicitly states: "Mechanical test results demonstrate that the proposed Cimplicity System is substantially equivalent to the predicate device." This is the core "study" proving the device meets its (implied) acceptance criteria, which is to perform mechanically as well as or better than the predicate devices and to meet relevant engineering standards for spinal implants. The document does not contain details about the specific tests performed, the number of samples, or the quantitative results, only the conclusion of substantial equivalence.

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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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