The CAYMAN THORACOLUMBAR PLATES are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L1-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

Device Description

The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from CP Titanium and Ti6A14V per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the spine.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cayman Thoracolumbar Plate System.

It's important to note that this 510(k) summary is for a medical device (spinal fixation system), not a diagnostic AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable here. Medical device clearances like this typically focus on bench testing and substantial equivalence to previously cleared devices rather than clinical trials with human subjects for performance evaluation in the way an AI/ML algorithm would be.

Acceptance Criteria and Device Performance Study for the Cayman Thoracolumbar Plate System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test Standard)	Reported Device Performance (Compliance)
ASTM F1717 (Static Compression Bending)	Compliant
ASTM F1717 (Dynamic Compression Testing)	Compliant
ASTM F1717 (Static Torsion)	Compliant

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test, but standard bench testing typically involves multiple samples to ensure statistical validity for mechanical properties.
Data Provenance: Not applicable in the context of "data provenance" for patient data, as this is a mechanical device study. The tests were performed in a lab setting according to industry standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a mechanical device, and "ground truth" refers to the results of standardized bench tests, not expert interpretation of patient data. The "experts" would be the engineers and technicians performing the tests and analyzing the results according to ASTM standards.

4. Adjudication Method for the Test Set

Not Applicable. Mechanical testing to ASTM standards does not involve human adjudication in the way AI/ML diagnostic studies do. Results are based on quantifiable measurements against predefined pass/fail criteria within the standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This is a mechanical device, not an AI/ML diagnostic tool. Therefore, MRMC studies are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a mechanical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

Bench Test Standards: The "ground truth" used for this device's performance evaluation consisted of the mechanical performance criteria established by ASTM F1717 for spinal intervertebral body fixation orthoses.

8. The Sample Size for the Training Set

Not Applicable. This device is evaluated through physical bench testing, not through training an AI/ML model.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See above. There is no training set for an AI/ML model for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Cayman Thoracolumbar Plate System was tested in accordance with ASTM F1717, a recognized consensus standard for the mechanical testing of spinal intervertebral body fixation orthoses. The specific tests conducted included:

Static compression bending
Dynamic compression testing
Static torsion

The document states that the devices "were tested in static compression bending, dynamic compression testing and static torsion in accordance with ASTM F1717 and are considered substantially equivalent to other legally marketed devices." This statement implies that the device successfully met the acceptance criteria (performance thresholds) specified within ASTM F1717 for these mechanical properties. The basis for clearance is that the device demonstrates comparable mechanical performance to predicate devices (K081380, K971248, K031100, K062407, K922543) already on the market, sharing similar design, materials, and indications for use. This "substantial equivalence" is the primary mechanism for clearance for this type of medical device.

Summary

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K100061 Page 1

510(k) SUMMARY for the

FEB 1 2 2010

Cayman Thoracolumbar Plate System, Longer Screws

This safety and effectiveness summary for the Cayman Thoracolumbar Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

1. Submitter :		Contact Person :
K2M, Inc.		Nancy Giezen
751 Miller Drive SE,		K2M, Inc.
Suite F1		751 Miller Drive SE, Suite F1
Leesburg, VA 20175		Leesburg, VA 20175
		Telephone: 703-777-3155
Date Prepared:	January 08, 2010

2. Tradename:	Cayman Thoracolumbar Plate System
Common Name:	Thoracolumbar Plates and Screws
Classification Name:	Spinal intervertebral body fixation orthosis (21 CFR 888.3060)
Product Code:	KWQ

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

K2M Cayman Thoracolumbar Plate System, K081380 .
. DePuy Kaneda SR, K971248
Synthes VentroFix, K031100 ●
Globus Medical Gateway, K062407 .
◆ Medtronic Sofamor Danek Z-Plate II, K922543

4. Description of the device:

Materials: The devices are manufactured from CP Titanium and Ti6A14V per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the spine.

5. Intended Use:

The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (TI-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LI-SI). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, i) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

6. Technological and Performance Characteristics:

The Cayman Thoracolumbar Plates were tested in static compression bending, dynamic compression testing and static torsion in accordance with ASTM F1717 and are considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by a serpent and topped with wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

K2M, Inc. % Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive, S.E., Suite F1 Leesburg, VA 20175

FEB 1 2 2010

Re: K100061

Trade/Device Name: Cayman Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 8, 2010 Received: January 12, 2010

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 for association 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). and oosmetire fore, market the device, subject to the general controls provisions of the Act. The I va mayy ators provisions of the Act include requirements for annual registration, listing of general controll proficituring 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 11 your artise 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 r road be action and a determination that your device complies with other requirements of the Act that I Drivias intacted and regulations administered by other Federal agencies. You must or any 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

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Page 2 – Ms. Nancy Giezen

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/ReportalProblem/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. Milliken

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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Indications for Use

510(k) Number (if known): K| 0006 |

Device Name: Cayman Thoracolumbar Plate System

Indications for Use:

Prescription Use X (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

210(k) Number_K10006 I

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.