(89 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Substantial Equivalence to Predicate Devices | "Mechanical test results demonstrate that the proposed Cimplicity System is substantially equivalent to the predicate device." |
| Biomechanical Integrity Restoration | "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." |
| Safety and Effectiveness (overall goal of 510(k)) | Demonstrated by meeting mechanical equivalence. |
| Approved Indications for Use (Cervical and Thoracolumbar) | The device is indicated for specific uses in the thoracolumbar and cervical spine as described in the "Indications for Use" section. |
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.
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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. -
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. -
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. -
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. -
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. -
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. -
The sample size for the training set:
Not applicable as this is not an AI/machine learning study. -
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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.