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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary

Date Submitted:	November 21, 2007
Manufacturer:	SpineSmith USA5300 N. Lamar, Suite 107Austin, TX 78751	FLE 7
Contact Name:	Robert Jones
Phone:	512-302-0086
Device Trade Name:	Cimplicity
Common Name:	Interbody Fusion Device
Regulatory Class:	888.3080
Classification Code:	Class II
Product Code:	ODP
Predicate Devices:	Affinity Cervical Cage (P000028) and others.
Device Description:	The Cimplicity system is a rectangular interbody fusion device. Thedevice is hollow and may be filled with graft material. Various sizesare provided to accommodate patient anatomy.
Intended Use:	The Cimplicity Spinal Fixation System is indicated for anterior cervicalinterbody fusion procedures in skeletally mature patients with cervicaldisc disease at one level from the C2-C3 disc to the C7-T1 disc.Cervical disc disease is defined as intractable radiculopathy and/ormyelopathy with herniated disc and/or osteophyte formation onposterior vertebral endplates producing symptomatic nerve root and/orspinal cord compression confirmed by radiographic studies. Cimplicityimplants are to be used with autogenous bone graft and implanted viaan open, anterior approach.
Materials:	Cimplicity is made from PEEK and has tantalum beads used forradiographic visualization.
Substantial Equivalence:	The Cimplicity Spinal System was tested and compared to predicatedevices and found to be substantially equivalent in terms of intendeduse, mechanical properties and material composition.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human services, featuring three overlapping, curved lines.

Public Health Service

FEB - 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine Smith Partners L.P. % Mr. Robert Jones Vice President, Research and Development 5300 North Lamar Boulevard #107 Austin, Texas 78751

Re: K073320

Trade/Device Name: Cimplicity Spinal Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 11, 2008 Received: January 14, 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.

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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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Wilkinson

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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Statement of Indications for Use

510(k) Number: K073320

Device Name: Cimplicity Spinal Fixation System

Indications for Use:

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 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.

Prescription Use X

Over the counter

(Per 21 CFR 801.109)

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

Soubara Boucher

Division of General, Restorative. and Neurological Devices

510(k) Number R073320

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.