The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
Spondylolisthesis
Spinal stenosis
Fracture/dislocation
Revision of previous cervical spine surgery
Tumors
Atlantoaxial fracture with instability
Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

Device Description

The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.

Materials: The devices are manufactured from Ti6AI4V Eli and Cobalt Chrome per ASTM and ISO standards.

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

AI/ML Overview

The provided text is a 510(k) summary for the Caspian Spinal System, a medical device. It focuses on demonstrating substantial equivalence to previously marketed devices based on mechanical testing and design comparisons, rather than clinical efficacy studies with acceptance criteria, human readers, or ground truth.

Therefore, most of the requested information cannot be extracted from this document as it does not describe a study involving an AI device or a device whose performance is measured against acceptance criteria in a clinical context.

Here's what can be extracted:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated as acceptance criteria in the context of clinical performance metrics.	"The Caspian Spinal System performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717."
	"The design features and sizing of the components were also compared and the Caspian Spinal System was found to be substantially the same as these systems."
	"There are no significant differences between the Caspian Spinal System and other systems currently being marketed which would adversely affect the use of the product."

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. The study described is mechanical testing, not a clinical study with a test set of data.

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. There was no ground truth based on expert review for a test set.

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

Not applicable. No expert adjudication for a test set was mentioned.

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 document describes a spinal implant, not an AI device or a device involving human readers.

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

Not applicable. This device is a physical spinal fixation system, not an algorithm.

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

Not applicable. The 'ground truth' for this mechanical testing would be the measured physical properties and performance of the device and its predicates, compared to established ASTM standards.

8. The sample size for the training set

Not applicable. There is no training set for an AI algorithm mentioned in this document.

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

Not applicable. There is no training set for an AI algorithm mentioned in this document.

Summary

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<1.03232.

510(k) Summary for the Caspian Spinal System

JAN 1 3 2011

This 510(k) summary for the Caspian 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 Fl Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155

Date Prepared: 11/01/10

Tradename:

Common Name: Classification Name: Device Product Code: Regulatory Class:

Caspian Spinal System Spinal Fixation System Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) KWP Class II

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

. K2M Caspian Spinal System (K081107, K092640, K093534, K101084)
. Biomet Altius (K033961)
. DePuy Mountaineer (K042508)

4. Description of the device:

Materials: The devices are manufactured from Ti6AI4V Eli and Cobalt Chrome per ASTM and ISO standards.

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

5. Intended Use:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history . and radiographic studies)
. Spondylolisthesis
Spinal stenosis
. Fracture/dislocation
Revision of previous cervical spine surgery
. Tumors
Atlantoaxial fracture with instability .
Occipitocervical dislocation

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

K103232

The occipital bone screws are limited to occipital fixation only.

The rod and hook components are intended for use in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in T 1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

1. Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Caspian Spinal System was mechanically tested and compared to predicate devices. The Caspian Spinal System performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717. The design features and sizing of the components were also compared and the Caspian Spinal System was found to be substantially the same as these systems.
  There are no significant differences between the Caspian Spinal System and other systems 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.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, with three wavy lines representing the body and head. The logo is black and white.

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 F1 Leesburg, VA 20175

JAN 1 3 2011

Re: K103232

Trade/Device Name: Caspian Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 17, 2010 Received: December 20, 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 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

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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/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 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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JAN 1 3 2011

Indications for Use

510(k) Number (if known): K103232

Device Name: Caspian Spinal System

Indications for Use:

. DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
. Spondylolisthesis
. Spinal stenosis
. Fracture/dislocation
. Revision of previous cervical spine surgery
. Tumors
. Atlantoaxial fracture with instability
Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm rod connectors or transitional rods.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K103232 510(k) Number_

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.