When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System 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 radies), The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤ 15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screw and 3-screw implants, respectively),

Device Description

The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA ® LT1 (Invibio™) per ISO 10993-1 USP Class VI, and ASTM F2026 and CP titanium per ASTM F67. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560. The screws are fabricated from Ti6Al4V per ASTM 1472.

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

The purpose of this 510(k) submission is primarily to add additional cervical and lumbar lordotic implants.

AI/ML Overview

This document is a 510(k) premarket notification for the K2M Chesapeake Stabilization System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance evaluations (mechanical testing). Therefore, it does not contain the type of information typically found in a study proving a device meets acceptance criteria related to clinical performance or AI/software analysis.

Based on the provided text, the device is a medical implant, and the approval is based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical mechanical testing. There is no mention of a "study" in the sense of a clinical trial or a dataset-based performance evaluation as would be done for an AI/software device.

Here's an analysis based on the information that is present in the document, and what is absent:

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

Acceptance Criteria (Implicit from Mechanical Testing Standards): The document states that mechanical testing was performed "per ASTM F2077" (static compression, static compression shear, dynamic compression, dynamic torsion) and "per ASTM F2267" (expulsion, subsidence). For a device to be "substantially equivalent" based on these tests, it must meet the performance requirements or be comparable to the predicate devices when tested to these standards. The specific quantitative acceptance criteria (e.g., minimum load to failure, maximum deformation) are not explicitly stated in this summary document but would be defined within the referenced ASTM standards and often compared directly to the predicate's performance.
Reported Device Performance: The document only states that "the proposed implants were determined to be substantially equivalent to predicate devices." It does not provide numerical results for the mechanical tests.

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

Sample Size: For mechanical testing, this refers to the number of test specimens. This information is not provided in the summary.
Data Provenance: Not applicable in the context of mechanical testing for a 510(k) submission.

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

This question is not relevant to this document. The "ground truth" for mechanical testing is derived from the physical properties and behavior of the materials and device design when subjected to specified loads, evaluated against engineering standards, not through expert human assessment of images or clinical outcomes.

4. Adjudication method for the test set

This question is not relevant to this document. Adjudication methods like 2+1 or 3+1 are used for clinical or image interpretation studies where there's a need to resolve discrepancies among human readers/experts.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

No. This document describes a medical device (spinal stabilization system) and a 510(k) submission primarily based on non-clinical mechanical testing. MRMC studies are typically performed for diagnostic devices, particularly those involving human interpretation of medical images, often comparing human readers with and without AI assistance.

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

No. This question is not relevant to this document as it relates to an algorithm/AI performance, which is not what this submission is about.

7. The type of ground truth used

Mechanical Properties and Standards Conformance: The "ground truth" for this device's performance evaluation is implicit in the internationally recognized ASTM standards (ASTM F2077, ASTM F2267) which define methodologies for testing spinal implants. The device's physical performance (e.g., strength, stability, resistance to expulsion) under simulated physiological conditions is the "truth" being assessed for substantial equivalence.

8. The sample size for the training set

Not applicable. This document describes a physical medical device (implants) and mechanical testing, not an AI or software device that would require a training set.

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

Not applicable. As above, there is no training set for a physical device.

In summary:

This 510(k) summary report details the premarket notification for a physical medical device, the Chesapeake Stabilization System, which is an intervertebral body fusion device. The primary method of demonstrating substantial equivalence for this submission was non-clinical mechanical testing according to established ASTM standards. The document does not describe a clinical study or an AI/software performance study with acceptance criteria, sample sizes, expert adjudication, or ground truth establishment as would be typically requested for software as a medical device (SaMD) or AI-enabled diagnostics. The acceptance criteria are implicitly meeting the performance requirements of the referenced ASTM standards and demonstrating equivalence to predicate devices in those mechanical tests, though specific numerical results are not provided in this summary.

Summary

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

May 7, 2015

K2M, Incorporated Ms. Nancv Giezen Manager, Regulatory Affairs 571 Miller Drive Southeast Leesburg, Virginia 20175

Re: K142487

Trade/Device Name: Chesapeake Stabilization System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, OVE Dated: April 21, 2015 Received: April 22, 2015

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 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

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Page 2 - Ms. Nancy Giezen

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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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) K142487

Device Name

Chesapeake Stabilization System

Indications for Use (Describe)

The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation

(i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤ 15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screw and 3-screw implants, respectively),

Type of Use (Select one or both, as applicable)
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	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 703-777-3155 Date Prepared: 05/05/2015

Classification

Trade Name: Chesapeake Stabilization System Common Name: Spinal Fixation System Regulatory Class: Class II

Classification Name(s):

Intervertebral Body Fusion Device with Integrated Fixation (21 CFR 888.3080, Product Code OVD. OVE)

Predicate Device(s)

Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K111439, K133494) K2M Aleutian (K082698, K133614) NuVasive Brigade (K123045)

Device Description

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

The purpose of this 510(k) submission is primarily to add additional cervical and lumbar lordotic implants.

Intended Use

When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft

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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.

When used as a lumbar intervertebral body fusion device. the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., < 15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).

Technological Comparison to Predicate(s)

The Chesapeake Stabilization System was compared to predicate systems and were found to be substantially the same as these systems.

Non-clinical Performance Evaluation

Mechanical testing including static compression, static compression shear, dynamic compression and dynamic torsion (per ASTM F2077), expulsion, and subsidence (per ASTM F2267) was performed in support of this submission and the proposed implants were determined to be substantially equivalent to predicate devices.

Conclusion

There are no significant differences between the proposed Chesapeake spacers and other devices currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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.