The Cutting Edge Spine Interbody Fusion Device (CES) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The CES device is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal.or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF, CES-CLIF and CES-RLF devices may be implanted singly or in pairs in the lumbosacral spine. The CES device is intended to be used with supplemental fixation.

Device Description

The CES device is a family of PEEK-OPTIMA spacers offered in a variety of widths and lengths. There are five main configurations: CES-PLIF, CES-TLIF, CES-CLIF and CES-RLIF. The different configurations allow for multiple surgical technique options. The CES-PLIF, CES-LIF, CES-CLIF and CES-RLIF are generally rectangular in shape while the CES-TLIF is curved.

The CES implants are available in a range of sizes, as well as flat and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the spacers as an option to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The spacers themselves are made of biocompatible PEEK-Optima LT1 (per ASTM F2026-08) material and provided nonsterile for single-use.

AI/ML Overview

The provided text describes the submission for a 510(k) premarket notification for the Cutting Edge Spine Interbody Fusion Device (CES). This device is an intervertebral body fusion device, which falls under a different category than AI/ML-driven diagnostic or therapeutic devices.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details), which are typically associated with performance studies for AI/ML medical devices, does not apply to this submission.

The 510(k) summary for the CES device focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through preclinical bench testing and adherence to FDA guidance for mechanical and material properties.

Here's why the specific questions about AI/ML performance studies are not relevant in this context:

Device Type: The CES is a physical implant (a PEEK spacer) used in spinal fusion surgery, not a software algorithm that analyzes data or images.
Regulatory Pathway: The 510(k) pathway for a device like this relies on demonstrating that it is as safe and effective as a predicate device, often achieved through materials testing, mechanical testing, and comparison of design features and indications for use. It does not typically involve clinical performance studies in the same way an AI diagnostic would.
"Acceptance Criteria" for Predicate Devices: For mechanical devices like this, "acceptance criteria" generally refer to meeting specified engineering and materials standards (e.g., ASTM standards for mechanical strength, biocompatibility testing), rather than clinical accuracy metrics like sensitivity or specificity.

Instead, the document highlights the following performance aspects:

Acceptance Criteria & Reported Performance (Paraphrased for this type of device):

Acceptance Criteria (Type of Testing)	Reported Device Performance (Summary)
Mechanical Performance:	Substantially equivalent performance characteristics to identified predicate devices as demonstrated by preclinical testing.
Static Compression	Testing conducted per ASTM F2077
Static Compression Shear	Testing conducted per ASTM F2077
Static Torsion	Testing conducted per ASTM F2077
Dynamic Compression	Testing conducted per ASTM F2077
Subsidence	Testing conducted per ASTM F2267
Expulsion	Testing conducted per ASTM F2267
Biocompatibility:	Made of biocompatible PEEK-Optima LT1 material (per ASTM F2026-08).
Material Properties:	Made of PEEK material, similar to predicate devices.
Design & Indications:	Similar shapes, sizes, and Indications for Use as predicate devices.

Sample Size used for the test set and data provenance: Not applicable. The "test set" here refers to preclinical bench testing of the device itself, not a dataset for an AI algorithm. The provenance is the testing laboratory.
Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for an AI algorithm is not relevant here. Ground truth for mechanical testing would be the physical measurement standards.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device.
If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
The type of ground truth used: Not applicable in the AI/ML context. For this device, ground truth relates to meeting established mechanical and material engineering standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K102957

510(k) Summary

1. Applicant

Cutting Edge Spine, LLC 2028 Kings Manor Drive Matthews, NC 28104 Contact Person: Randy Roof, Manager Tel: (704) 839-1916

Fax: (704) 731-2559 Email: mrnuspine@me.com

Application Correspondent:

Kapstone Medical, LLC 100 E. South Main St. P.O. Box 1458 Waxhaw, NC 28173 Contact Person: John Kapitan, President, Kapstone Medical LLC Tel: (704) 843-7852 Fax: (704) 831-5316

E-mail: jkapitan@kapstonemedical.com

Date Prepared: October 1, 2010

2. Device Name

Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification: Panel:

Intervertebral fusion device with bone graft, lumbar Intervertebral body fusion device 888.3080 MAX ll Orthopedic

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3. Predicate Devices

The Cutting Edge Spine Interbody Fusion Device (CES) is substantially equivalent to the following device:

510(k) Number	Device	Manufacturer
K090707	Talos Intervertebral Body Fusion Device	Meditech Advisors, LLC
P960025 (PMA)	Lumbar I/F Cage® System	DePuy Spine
P950002 (PMA)	BAK® Interbody Fusion System	Zimmer
K071724	Lucent device	Spinal Elements

4. Description of the Device

5. Indications for Use

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singly or in pairs in the lumbosacral spine. The CES device is intended to be used with supplemental fixation.

6. Summary of Performance Data

The CES device was tested in compliance with FDA's guidance document titled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". Preclinical testing according to ASTM F2077 and ASTM F2267, including static compression, static compression shear, static torsion, dynamic compression, subsidence and expulsion was conducted.

Preclinical testing demonstrated substantially equivalent performance characteristics to the identified predicate devices.

7. Safety & Effectiveness

The CES device is substantially equivalent to the identified predicate devices. All of these devices are made of biocompatible PEEK material, have similar shapes and sizes, have similar Indications for Use, are available by prescription only, and are provided non-sterile for single-use only.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and head turned to the right. The image is in black and white.

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

Cutting Edge Spine, LLC % Mr. John Kapitan Kapstone Medical, LLC P.O. Box 1458 Waxhaw, North Carolina 28173

APR 2 8 2011

Re: K102957

Trade/Device Name: Cutting Edge Spine Interbody Fusion Devices (CES) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 15, 2011 Received: April 21, 2010

Dear Mr. Kapitan:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. John Kapitan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CrK rail 607), labeling (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 11 you desire specific advice for your comters offices/CDRH/CDRHOffices/ucm115809.htm for go to mtd.//www.idagov.it Bodiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radional by reference to premarket notification (21CFR Part note the regulation cinnition, "Misorananing 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 r ou may obtain offer general mormational 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 yours,

My B. R. to

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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102957

Indications for Use Statement

510(k) Number (if known): K102957

Device Name: Cutting Edge Spine Interbody Fusion Device (CES)

Indications for Use:

The Cutting Edge Spine Interbody Fusion Device (CES) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-51. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The CES device is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF, CES-CLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The CES device is intended to be used with supplemental fixation.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

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(Division Sign Off)

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

K102957 510(k) Number_

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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.