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

Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

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 Ti6Al4V per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.

AI/ML Overview

The provided document is a 510(k) summary for the Caspian Spinal System, a medical device. It does not contain information about acceptance criteria or a study proving performance in the context of device performance metrics like sensitivity, specificity, accuracy, or any statistical measures typically associated with AI/software device evaluation.

Instead, this document focuses on establishing substantial equivalence to legally marketed predicate devices, a regulatory pathway for physical medical devices. The "study" mentioned here is the comparison to predicate devices, asserting similarities in design, material, and indications for use.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (MRMC, standalone algorithm performance) is not applicable or cannot be extracted from this specific document.

I will fill in the table and address the questions to the best of my ability based on the provided text, indicating when information is "Not Applicable" or "Not Provided."

Description of the Acceptance Criteria and Study

The Caspian Spinal System seeks clearance through the 510(k) pathway by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are not performance metrics like accuracy or sensitivity, but rather the demonstration that the new device is as safe and effective as existing, legally marketed devices.

The "study" that proves the device meets "acceptance criteria" is the detailed comparison of its technological characteristics, materials, and intended use against those of the identified predicate devices. The conclusion of this comparative analysis is that the Caspian Spinal System is "substantially equivalent" to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as inferred from 510(k))	Reported Device Performance / Justification
Material Equivalence	Manufactured from Ti6Al4V per ASTM and ISO standards (matching predicate materials).	"The devices are manufactured from Ti6Al4V per ASTM and ISO standards." Implicitly equivalent to predicate devices.
Design Equivalence	Top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system, consisting of pedicle screws, rods, locking set screws, hooks, and rod connectors.	"The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system... " Similar in design to predicates.
Intended Use Equivalence	Indicated for DDD, Spondylolisthesis, Spinal Stenosis, Fracture/dislocation, Revision of previous cervical spine surgery, Tumors, and stabilization as an adjunct to fusion for specific spinal segments.	Indications for use are listed and are presented as being analogous to, or within the scope of, predicate device indications.
Safety & Effectiveness	Expected to be equivalent in safety and effectiveness to predicate devices.	"The Caspian Spinal System is 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."

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

Sample Size for Test Set: Not Applicable. This is a comparison to predicate physical devices, not a performance study on a test dataset.
Data Provenance: Not Applicable.

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. "Ground truth" in the context of diagnostic or AI performance is not relevant for this type of 510(k) submission for a spinal implant system. The "ground truth" here is the established safety and effectiveness of the predicate devices.

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

Not Applicable.

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 is not an AI/software device.

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

Not Applicable. This is not an AI/software device.

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

The "ground truth" for this submission is implicitly the established safety and effectiveness track record of the predicate devices based on their prior regulatory clearance and market experience.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device.

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

Not Applicable.

Summary

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K081107

Page 1 of 2

OCT 1 0 2008

510(k) Summary for the Caspian Spinal System

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

1. Submitter : K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175

Date Prepared: 10/10/08

Contact Person :

Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite Fl Leesburg, VA 20175 Telephone: 703-777-3155

2. Tradename:	Caspian Spinal System
Common Name:	Spinal Fixation System
Classification Name:	Spinal Interlaminal Fixation Orthosis (21CFR 888.3050)
Device Product Code:	KWP
Regulatory Class:	Class II

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

. Synthes Starlock/ Cervifix
. Interpore Mini VLS/ Altius
. DePuy Mountaineer
. Spinal Concepts Octafix

4. Description of the device:

Materials: The devices are manufactured from Ti6Al4V per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.

5. Intended Use:

The Caspian Spinal System is indicated for the following:

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

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K081107

Page 2 of 2

1. Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Caspian Spinal System is 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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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 caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

Re: K081107 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: October 09, 2008 Received: October 10, 2008

Dear Mr. Woods:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Richard W. Woods

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millerson

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Caspian Spinal System

Indications for Use:

The Caspian Spinal System 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

Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating theracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

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 B

Mark A. Mckinnon

Division Sign-Off) vision of General. Bestorative. and Neurological Devices

Si3(E) Number

KO81/07

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.