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.

Device Description

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.

AI/ML Overview

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.

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.

Summary

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K080971 (pg. 1 of 2)

JUL - 2 2008

SpineSmith Cimplicity Spinal System

510(k) Summary of Safety and Effectiveness

SUBMITTED BY	SpineSmith Partners, LP8140 N. Mopac, Bldg II, Suite 120Austin, TX 78759
ESTABLISHMENTREGISTRATION NUMBER	3006404071
CONTACT PERSON	Robert JonesVice President, Research and DevelopmentPhone: 512-206-0770Fax: 512-637-6750Email: rjones@spinesmithusa.com
SUBMISSION PREPARED BY	Lisa PetersonKaedon Consulting, LLCPhone: 512-507-0746
DATE PREPARED	April 2, 2008
CLASSIFICATION	MQP 888.3060- Spinal Intervertebral Body FixationOrthosisODP 888.3080 - Intervertebral fusion device with bone graft,cervical
COMMON NAME	Spinal Vertebral Body Replacement System (MQP)Intervertebral body fusion device (ODP)
PROPRIETARY NAME	SpineSmith Cimplicity Spinal System
PREDICATE DEVICE(S)	SpineSmith Cimplicity Spinal System (K073320)LDR Spine MC+ (K043479)Spinal Elements, Inc. Crystal (K073351)
SUBSTANTIALEQUIVALENCE	The SpineSmith Cimplicity System was determined to besubstantially equivalent to several commercially availablesystems.

DEVICE DESCRIPTION

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INDICATIONS:

MECHANICAL TEST DATA

Mechanical test results demonstrate that the proposed Cimplicity System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine Smith Partners % Mr. Robert Jones Vice President, Research and Development 8140 North Mopac Building II, Suite 120 Austin, TX 78759

K080971 Re:

Trade/Device Name: Cimplicity Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal vertebral body fixation device Regulatory Class: II Product Code: MQP, ODP Dated: April 2, 2008 Received: April 4, 2008

Dear Mr. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

JUL - 2 2008

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Page 2 - Mr. Robert Jones

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K080971

Device Name:

SpineSmith Partners, LP Cimplicity System

Indications for Use:

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 TI to LS) 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 imvlants 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.

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	L08091
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Regulation Number and Section

§ 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.