The Cezanne II Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade l spondylolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Device Description

The Cezanne II Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Cezanne II System consists of XLIF, TLIF and ALIF implants.

The System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

Note: The provided text describes a 510(k) premarket notification for a medical device, the "Accel Spine Cezanne II Interbody Fusion System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing (mechanical tests). It does not involve clinical studies or AI algorithm performance, which are the typical contexts for the acceptance criteria and study design questions you've posed.

Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary. I will answer based only on the information present in the document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Static and dynamic compression testing conformance: To ASTM F2077-11	Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F2077-11), demonstrating that minor differences do not impact device performance as compared to predicates.
Subsidence testing conformance: To ASTM F2267-04	Substantially equivalent results of non-clinical testing relative to subsidence (per ASTM F2267-04), demonstrating that minor differences do not impact device performance as compared to predicates.
Expulsion testing conformance: To ASTM Draft Standard F-04.25.02.02	Substantially equivalent results of non-clinical testing relative to expulsion (per ASTM Draft Standard F-04.25.02.02), demonstrating that minor differences do not impact device performance as compared to predicates.
Material Conformance (PEEK Optima LT1): To ASTM F2026	The System implant components are made of PEEK Optima LT1 that conforms to ASTM F2026.
Material Conformance (Tantalum markers): To ASTM F560	The devices contain tantalum markers (ASTM F560).
Material Conformance (Instruments): To ASTM F899	Device-specific and universal Class I instruments are manufactured from stainless steel materials that conform to ASTM F899.
Intended Use Equivalence:	Same intended use as predicate devices: intervertebral body fusion of the lumbar spine (L2-S1), 1 or 2 contiguous levels, for DDD with Grade I spondylolisthesis/retrolisthesis, with supplemental fixation and autograft.
Design Equivalence:	Similar primary implant design as predicate devices.
Material Equivalence:	Equivalent material of manufacture as predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. The study involved non-clinical mechanical testing of the device, not a test set of data such as images or patient records.
Data Provenance: Not applicable. The "data" comes from engineering tests performed according to specific ASTM standards in a lab setting, not from patients or a specific country of origin. The tests were "non-clinical."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of expert review, is not relevant for this type of non-clinical mechanical testing. The "ground truth" for these tests is defined by the objective physical properties and performance measured according to the specified ASTM standards.

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

Not applicable. Adjudication methods are used in studies involving expert review or subjective interpretation of data, which is not the case here.

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

Not applicable. This is a 510(k) submission for an interbody fusion system, not an AI-powered diagnostic device. No MRMC study was conducted.

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

Not applicable. This is a physical medical device (interbody fusion system), not an algorithm or AI.

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

The "ground truth" for the non-clinical testing is defined by the objective measurements and pass/fail criteria established by the specific ASTM standards (F2077-11, F2267-04, F-04.25.02.02, F2026, F560, F899). It is a form of empirical measurement against established engineering standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model requiring a training set.

Summary

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K131981 Page 1. of 2

510(k) Summary Accel Spine Cezanne II Interbody Fusion System Premarket Notification

SUBMITTED BY

Accel Spine 14901 Quorum Dr. Ste. 125 Dallas, TX 75254

ESTABLISHMENT REGISTRATION NUMBER

10035914

3009051471

OWNER/OPERATOR NUMBER

CONTACT PERSON

Lisa Peterson Kaedon Consulting, LLC 512-507-0746 (phone) 512-266-3364 (fax)

August 16, 2013

CLASSIFICATION NAME

Intervertebral Body Fusion Device

888.3080 (Product Code MAX)

Cezanne II Interbody Fusion System

DEVICE CLASS

DATE PREPARED

Class II

REGULATION NUMBER

COMMON NAME

Intervertebral Fusion Device with Bone Graft, Lumbar

PROPRIETARY NAME

IDENTIFICATION OF PREDICATE DEVICE(S)

Predicate devices include various cleared interbody fusion systems:

Eminent Spine: Eminent Spine Interbody Fusion System ー (K090064)
DePuy Acromed: Lumbar I/F Cage (P960025) -
Genesys Spine: Genesys Spine Interbody Fusion -System (K103034)
Spine 360: Spine 360 Interbody Fusion System -(K102322)
Lanx, Inc.: Lanx Fusion System Lateral (K103666) 구

OCT 09 2013

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DEVICE DESCRIPTION

The Cezanne II Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Cezanne II System consists of XLIF, TLIF and ALIF implants.

The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

INDICATIONS

The Cezanne II Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Cezanne II Interbody Fusion System. The System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

Intended for use at either one level or two contiguous levels for the treatment of degenerative ﮯ disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Substantially equivalent results of non-clinical testing relative to static and dynamic testing . (per ASTM F2077-11 ). subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-11 -
Subsidence testing, conducted in accordance with ASTM F2267-04 ャ
Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 -

CONCLUSIONS

The subject and predicate device(s) share the same intended use. primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Accel Spine Cezanne II Interbody Fusion System is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 9, 2013

Accel Spine % Ms. Lisa Peterson Principal Consultant Kacdon Consulting 14001 Hunters Pass Austin, Texas 78734

Rc: K131981

Trade/Device Name: Cezanne II Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 13, 2013 Received: September 16, 2013

Dear Ms. Peterson:

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 docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not mislcading.

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 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 of medical

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Page 2 - Ms. Lisa Peterson

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entilled, "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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin-I. Keith

for

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K131981

Device Name:

Cezanne II Interbody Fusion System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

AND/OR

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.