CHESAPEAKE (CERVICAL COMPONENTS) by K2M, INC.

When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

Device Description

The Chesapeake Spinal System consists of interbody implants and titanium bone screws intended for fusion, without the need for supplementary fixation. The implants are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The cervical interbody implants are made of CP titanium and the screws are fabricated from Ti6Al4V titanium, in accordance with ASTM F67 and F1472

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.

AI/ML Overview

This document, K111439, describes the 510(k) summary for the Chesapeake Spinal System from K2M, Inc. It's a medical device submission, and as such, the "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to existing legally marketed devices, rather than a clinical study establishing AI performance metrics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone AI performance) are not applicable in the context of this device and its 510(k) submission. This is a traditional medical device, not an AI/ML-driven device.

Here's the breakdown based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Mechanical Testing	Device performance should be "equally to or better than" predicate devices in static and dynamic compression, expulsion, subsidence, and torsion, in accordance with ASTM F2077 and F2267.	"The Chesapeake Spinal System performed equally to or better than these systems in static and dynamic compression, expulsion, subsidence, and torsion, in accordance with ASTM F2077 and F2267."
Component Comparison	Device components should be "substantially the same as" predicate devices.	"[Other] components were also compared and the Chesapeake Spinal System was found to be substantially the same as these systems."
Design, Function, Material, Intended Use Equivalence	No significant differences compared to other marketed wires (implants) that would affect the use of the product, and it should be substantially equivalent to other devices in design, function, material, and intended use.	"There are no significant differences between the K2M implants and other wires currently being marketed. This will not affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."
Materials	Cervical interbody implants made of CP titanium and screws from Ti6Al4V titanium, in accordance with ASTM F67 and F1472.	"The cervical interbody implants are made of CP titanium and the screws are fabricated from Ti6Al4V titanium, in accordance with ASTM F67 and F1472." (This is a description, but implicitly an acceptance criterion for material compliance.)
Intended Use	To be used with bone screws provided, requiring no additional supplementary fixation. Indicated as a cervical intervertebral body fusion device with autogenous bone graft in skeletally mature patients, at one level (C2-T1) for cervical disc disease (discogenic neck pain with degeneration confirmed by history/radiography), for patients with six weeks of non-operative treatment.	"The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment." (This is a statement of intended use, which the device is claimed to meet.)

The subsequent points (2-9) are largely not applicable to this 510(k) submission, as it pertains to a mechanical intervertebral body fusion device, not an AI/ML diagnostic or prognostic tool. The "study" mentioned is primarily a series of mechanical bench tests demonstrating physical equivalence to predicate devices.

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

Not applicable / Not specified for a clinical AI test set. The "test set" here refers to the physical devices and materials used in the mechanical and material testing. The document does not specify the number of devices or components tested. The provenance would be the manufacturing site of K2M, Inc. (Leesburg, VA, USA).

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)

Not applicable. No expert ground truth establishment for an AI test set is mentioned. The ground truth for mechanical testing is established by engineering standards (ASTM F2077, F2267).

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

Not applicable. This concept pertains to resolving discrepancies in image interpretations or other subjective assessments in AI studies. It is not relevant for mechanical device testing.

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

No, not applicable. This is a mechanical device, not an AI system that assists human readers.

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

Not applicable. This is a physical implant, not a standalone algorithm.

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

Engineering Standards / Material Specifications: For mechanical testing, the "ground truth" is defined by the performance requirements outlined in the ASTM standards (F2077, F2267) and the material specifications (ASTM F67, F1472). For the comparison to predicates, the "ground truth" is the established performance and characteristics of those predicate devices.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be required.

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

Not applicable. As there is no AI/ML model or training set, this question is irrelevant.

Summary

{0}------------------------------------------------

K11143.9

AUG 2 4 2011

510(k) Summary Chesapeake Spinal System K2M, Inc.

This 510(k) summary for the Chesapeake Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

Submitter :

K2M. Inc. 751 Miller Drive SE, Suite Fi Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155

Date Prepared: 08/23/11

2. Tradename:	Chesapeake Spinal System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device with Bone Graft, cervical
Device Product Code:	OVE
Regulation Number:	888.3080
Regulatory Class:	Class II

3. Predicate or legally marketed devices which are substantially equivalent :

K2M Chesapeake (K092211) .
. K2M Aleutian (K051454, K082698)
Surgicraft Stalif C (K072415) .
Globus Coalition (K083389) .
. Cardinal Spine STCC (K100698)

4. Description of the device:

The Chesapeake Spinal System consists of interbody implants and titanium bone screws intended for fusion, without the need for supplementary fixation. The implants are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The cervical interbody implants are made of CP titanium and the screws are fabricated from Ti6Al4V titanium, in accordance with ASTM F67 and F1472

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.

5. Intended Use:

The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation.

Page 1 of 2

{1}------------------------------------------------

1. Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Chesapeake cervical implants were mechanically tested and compared to predicate devices. The The Chesapeake Spinal System performed equally to or better than these systems in station Clicsapcake Spinal Pystem periornied equasion in accordance with ASTM F2077 and F2267. torslon, dyname compression, after components were also compared and the Chesapeake Spinal System was found to be substantially the same as these systems.
  There are no significant differences between the K2M implants and other wires currently being marketed I his are no significant affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

{2}------------------------------------------------

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The overall design is simple and recognizable.

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

K2M, Inc. % Ms. Nancy Giezen 751 Miller Drive SE, Suite Fl Leesburg, Virginia 20175

AUG 24 2011

Re: K111439

Trade/Device Name: Chesapeake Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: August 05, 2011 Received: August 08, 2011

Dear Ms.Giezen:

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

{3}------------------------------------------------

Page 2 - Ms. Nancy Giezen

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/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 yours,
Mark A. Millman

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

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

K111439

Chesapeake Spinal System Device Name :

Indications For Use :

The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation.

Prescription use______________________________________________________________________________________________________________________________________________________________

Over-the-counter use ( PER 21 CFR 801.109)

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

KII1439 510(k) Number_

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.