The CASPIAN OCT / MESA Mini / DENALI Mini 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
t 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 OCT / MESA Mini / DENALI Mini 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 OCT Spinal System is a top-loading, multiple component, posterior (occipital-cervicalthoracic) spinal fixation system. The purpose of this submission is to add the Occipital Anchor to the system.

Materials: The subject devices are manufactured from Ti6A14V Eli 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 describes a 510(k) summary for the Caspian OCT Spinal System, specifically focusing on the addition of an Occipital Anchor. The submission details the device, its intended use, and a comparison to predicate devices, along with mechanical and biomechanical testing to demonstrate substantial equivalence.

However, the document does not contain the kind of information typically associated with acceptance criteria for device performance in the context of clinical studies, diagnostic accuracy, or AI models. Instead, the "acceptance criteria" here refers to the demonstration of substantial equivalence to a previously cleared device, primarily through mechanical and biomechanical testing in accordance with ASTM standards.

Therefore, many of the requested categories in your prompt cannot be directly answered from the provided text, as they pertain to clinical or diagnostic performance studies that were not conducted or reported in this 510(k) summary. The summary focuses on the physical and functional characteristics of an implantable medical device.

I will fill in the table and address the other points based only on the information available in the provided text. Where information is not present, I will explicitly state that.

Acceptance Criteria and Study for the Caspian OCT Spinal System

The "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This was primarily achieved through mechanical and biomechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Performance equal to or better than original Caspian OCT Spinal constructs in static compression (per ASTM F2706)	Performed equally to or better than the original Caspian OCT Spinal constructs in static compression.
Performance equal to or better than original Caspian OCT Spinal constructs in static torsion (per ASTM F2706)	Performed equally to or better than the original Caspian OCT Spinal constructs in static torsion.
Performance equal to or better than original Caspian OCT Spinal constructs in dynamic compression (per ASTM F2706)	Performed equally to or better than the original Caspian OCT Spinal constructs in dynamic compression.
Biomechanical performance substantially the same as predicate devices (in cadaver testing)	Devices were found to perform substantially the same in biomechanical (cadaver) testing.

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

Test Set Sample Size: The document does not specify exact sample sizes (e.g., number of constructs or cadaveric specimens) for the mechanical or biomechanical testing. It refers to "the constructs" and "the devices."
Data Provenance: The mechanical testing was conducted by K2M, Inc. to ASTM standards. The biomechanical testing was "cadaver" testing, implying human cadaveric tissue. The country of origin for the data is not specified, but the submitter is K2M, Inc. in Leesburg, VA, USA. The studies are prospective in nature for validating the device's performance against established standards and predicate devices.

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

This information is not provided in the document. The "ground truth" for this device's performance is based on standardized mechanical testing (ASTM F2706) and comparative biomechanical testing against predicate devices, rather than expert interpretation of data.

4. Adjudication method for the test set

This information is not provided as the evaluation method was based on objective mechanical and biomechanical measurements against established standards and predicate device performance, not expert adjudication of subjective assessments.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance, which is not the nature of the Caspian OCT Spinal System (an implantable spinal fixation system).

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

No, a standalone algorithm performance study was not done. This concept is not applicable to an implantable spinal fixation system.

7. The type of ground truth used

The "ground truth" used for demonstrating substantial equivalence was:

Engineering Standards: Adherence to ASTM F2706 for static and dynamic mechanical properties.
Predicate Device Performance: Direct comparison of the new device's mechanical and biomechanical performance to that of previously cleared predicate devices (K2M Caspian OCT Spinal System K101084 and Medtronic Vertex K052402).

8. The sample size for the training set

This information is not provided and is not applicable. The listed studies are for device verification/validation, not for training an algorithm.

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

This information is not provided and is not applicable. There was no "training set" in the context of an algorithm or AI model development for this device submission.

Summary

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510(k) Summary for the Caspian OCT Spinal System

This 510(k) summary for the Caspian OCT 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: 10/24/13

1. Tradename:
  Common Name:

Classification Name:

Regulatory Class:

Device Product Code:

Caspian OCT 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 OCT Spinal System (K101084) .
Medtronic Vertex (K052402) t

4. Description of the device:

Materials: The subject devices are manufactured from Ti6A14V Eli 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:

해 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
t Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

K133288 Page 1 of 2

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The CASPIAN OCT / MESA Mini / DENALI Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

Comparison of the technological characteristics of the device to predicate and legally marketed devices : The subject components were mechanically tested and performed equally to or better than the original Caspian OCT Spinal constructs in static compression, static torsion and dynamic compression in accordance with ASTM F2706. The constructs were also compared in biomechanical (cadaver) testing and the devices were found to perform substantially the same.

There are no significant differences between the Caspian OCT 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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

)

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 1, 2014

K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite Fl Leesburg, Virginia 20175

Re: K133288

Trade/Device Name: Caspian OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: May 30, 2014 Received: June 2, 2014

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/ResourcesforYou/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/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 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.

Sincercly yours.

Ronald P. Jean -S for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133288

Device Name Caspian OCT Spinal System

Indications for Use (Describe)

The CASPIAN OCT/MESA Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervical-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 in or treat conditions involving the cervical spine.

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Division of Offhopedic Devices

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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.