Cezanne Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bonegraft. Cezanne Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Cezanne Lumbar Interbody Fusion Cage System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The Cezanne Lumbar Interbody Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA CTI (ASTM F2026) body with the tantalum(ASTM F560) marker pins.

AI/ML Overview

This document describes the regulatory submission for the "Cezanne Lumbar Interbody Fusion Cage System" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where a device's performance is measured against acceptance criteria in a clinical setting.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, how ground truth for training set was established) are not applicable or provided in this type of submission.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

This document does not present acceptance criteria and reported device performance in the context of a clinical study or a study designed to measure the device's diagnostic/performance characteristics against specific numerical targets. Instead, it relies on non-clinical (bench) testing to ensure mechanical integrity and comparability to predicate devices. The acceptance criteria for these tests would typically be defined by the ASTM standards cited.

Acceptance Criteria (Defined by ASTM Standards)	Reported Device Performance (Summary)
Static Axial Compression (ASTM F2077)	Device was tested and presumed to meet standard requirements
Dynamic Axial Compression (ASTM F2077)	Device was tested and presumed to meet standard requirements
Static Compression-Shear (ASTM F2077)	Device was tested and presumed to meet standard requirements
Dynamic Compression-Shear (ASTM F2077)	Device was tested and presumed to meet standard requirements
Static Torsion (ASTM F2077)	Device was tested and presumed to meet standard requirements
Dynamic Torsion (ASTM F2077)	Device was tested and presumed to meet standard requirements
Expulsion (ASTM F2077)	Device was tested and presumed to meet standard requirements
Static Subsidence (ASTM F2267)	Device was tested and presumed to meet standard requirements

Explanation: The document states that the system "has been tested" according to these ASTM standards. In a 510(k) submission, the implicit understanding is that these tests demonstrated performance comparable to predicate devices or within acceptable limits defined by the standards, thus supporting the claim of substantial equivalence. The specific numerical results are not provided in this summary but would be available in detailed test reports.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as this submission focuses on substantial equivalence based on mechanical testing and comparison to existing predicate devices, not on a clinical test set for performance evaluation in patients. The "test set" here refers to the physical devices subjected to bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of clinical expert consensus, is not relevant for this type of mechanical testing and substantial equivalence claim. The "ground truth" for these tests would be the established scientific principles of mechanical engineering and material science, as embodied in the ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments or when there's disagreement among experts. For mechanical bench testing, results are typically objective and quantifiable by standardized methods, not requiring adjudication.

5. 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

This information is not applicable. This is a submission for a physical intervertebral fusion cage, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" is established by engineering principles and standardized testing methodologies (ASTM International standards). These standards define how the material properties and device performance under specified loads should be measured and what constitutes acceptable performance for intervertebral fusion devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this 510(k) submission, as it relates to mechanical testing and substantial equivalence, not machine learning or AI.

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set, there is no ground truth for a training set to establish.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves" the device meets acceptance criteria is a series of non-clinical bench tests conducted according to recognized ASTM International standards. These tests assess the mechanical properties and performance of the Cezanne Lumbar Interbody Fusion Cage System.

Test Standards Utilized:
- ASTM F2077: Standard Test Methods for Static and Dynamic Axial Compression, Compression-Shear, and Torsion Testing of Intervertebral Body Fusion Devices
- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Objective of Testing: To demonstrate that the mechanical performance (e.g., strength, stability, resistance to subsidence, expulsion, etc.) of the Cezanne device is comparable to that of legally marketed predicate devices and is suitable for its intended use within the lumbar spine.
Conclusion: The submission concludes that the "Cezanne Lumbar Interbody Fusion Cage System has been tested [according to the listed standards]" and shares technological characteristics similar to predicate devices, implying that its performance is equivalent and therefore "safe and effective for its intended use." The FDA's substantial equivalence determination (K121567) indicates agreement with this conclusion based on the submitted data.

Summary

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510(k) SUMMAR

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

1.	Submitter:	AccelSpine LLC
		14850 Quorum Dr.Suite220Dallas, TX 75254
	Contact Person:	Daniel Chon
		Telephone. 800.713.9489
		FAX .888.831.4892
		dchon@accelspine.com
	Date Prepared	May 22, 2012

2. Device Identification

Trade Name	Cezanne Lumbar Interbody Fusion Cage System
Common/Usual Name	Intervertebral Fusion Device
Regulation Name	Intervertebral body fusion device (21 CFR 888.3080)
Regulatory Class	Class II
Product Code	MAX

3. Description of the Device

4. Indications for Use

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K121567
page 2 of 2

SACCES

5. Non-clinical Testing

The Cezanne Lumbar Interbody Fusion Cage System has been tested Static and Dynamic Axial Compression(ASTM F2077), Static and Dynamic Compression-Shear (ASTM F2077), Static and Dynamic Torsion (ASTM F2077), Expulsion (ASTM F2077), Static Subsidence (ASTM F 2267)

6. Summary of technology characteristics

The Cezanne Lumbar Interbody Fusion Cage System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials and the same intended use.

7. Predicate or legally marketed devices which are substantially equivalent The design feature and indications for use for the subject Cezanne Lumbar Interbody Fusion

Cage System is substantially equivalent to the following predicates:

··· L&K BIOMED: VENUS Lumbar Intervertebral Body Fusion Cage System (K110783, K120063, K121096)
··· GS Medical: Any Plus PEEK Cage (K100516)
··· STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704)
··· Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162)
··· Nuvasive: NuVasiveCoRoent System (K043405,K052210 K071795, K081611)
·· Spine Art : JULIET OL , DYNAMIK Intervertebral body fusion device (K081888, K101720)
••• Medtronic SofamorDanek: CLYDESDALE Spinal System (K100175,K112405,K113528)

8. Conclusion

The Cezanne Lumbar Interbody Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing another, symbolizing care and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Accel Spine LLC % L & K Biomed Company, Limited Ms. Ki Hyang Kim Vice President 1104-ho, 145, Gasandigital 1-ro, Geumcheon-gu Seoul. 153-787. Korea

Re: K121567

Trade/Device Name: Cezanne Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Invertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 22, 2012 Received: September 04, 2012

Dear Ms. Kim:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Ki Hyang Kim

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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

Enclosure

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CACCESPINE

Indications for Use

510(k) Number : K121567

Device Name : Cezanne Lumbar Interbody Fusion Cage System

Indications for Use :

Cezanne Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Cezanne Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

K121567 510(k) Number_

Cezanne Lumbar Interbody Fusion Cage System 510(K)

Page 29/ 92

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.