The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

degenerative disc disease (DDD) as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis. .
trauma (i.e., fracture or dislocation), .
spinal stenosis, .
atlantoaxial fracture with instability, .
occipitocervical dislocation, .
revision of previous cervical spine surgery, and/or .
. spinal tumor.
The occipital bone screws are limited to occipital fixation only.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Device Description

A new occipital plate design is being added to the Sierra spinal system. All products are fabricated from titanium alloy and cobalt alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

This document is a 510(k) premarket notification for the Sierra™ OCT Spinal System, specifically for the addition of a new occipital plate design. It is a submission to the FDA (Food and Drug Administration) for regulatory clearance. Since this is a submission for a Special 510(k) and the information provided points to substantial equivalence with existing predicate devices, the focus is on design and material equivalency, rather than clinical performance studies involving a test set, ground truth, or human-in-the-loop assessments as would be done for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The "acceptance criteria" here refer to satisfying FDA's requirements for substantial equivalence based on design, materials, and intended use.

Here's the breakdown of the information based on the provided document:

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

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance/Characteristics
Overall Design Equivalence to Predicate Devices (Sierra Spinal System K062934 and Interpore Cross International's Altius OCT System K022048, K033961, K043229)	"The overall design of the occipital plates in this submission is substantially equivalent to the predicate devices."
Materials Equivalence	"All products are fabricated from titanium alloy and cobalt alloy." (Implied to be equivalent to predicate device materials, as no material change is highlighted as a differentiator)
Intended Use Equivalence	"The statements of intended use are identical." The intended use is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions (DDD, spondylolisthesis, trauma, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, revision, spinal tumor). Specific limitations for occipital bone screws (occipital fixation only) and polyaxial screws (T1-T3 only, not cervical spine) are also identical.
Technological Characteristics Equivalence	"The addition of the new devices has not altered the fundamental scientific technology of the previously cleared system. The devices in this submission have substantially equivalent technological characteristics to the predicate devices."
Sterilization Status Equivalence	"All products are supplied "NON-STERILE" and must be sterilized prior to use." (Implied to be equivalent to predicate devices, as this is a common practice for such implants.)

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 (N/A). This submission is for a medical device (occipital plate) and relies on substantial equivalence to predicate devices, not clinical performance data from a test set of patients in the way an AI/ML device would. No patient data or test set in the traditional sense was used.

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)

N/A. Ground truth establishment is not relevant for this type of submission, which focuses on engineering and design equivalency.

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

N/A. No test set or human adjudication process as described is relevant.

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

N/A. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was conducted.

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

N/A. This is not an algorithm or AI system.

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

N/A. The "ground truth" equivalent in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness. The new device is deemed safe and effective because its characteristics are substantially equivalent to those already cleared devices.

8. The sample size for the training set

N/A. No training set is relevant for this device.

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

N/A. No ground truth for a training set was established.

Summary

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K080526

CONFIDENTIAL

Sierra™M
----------

	Special 510(k) Summary
Submitter:	SeaSpine Inc.2302 La Mirada Dr.Vista, CA 92081Phone: (760) 727-8399	Fax: (760) 727-8891
Contact person:	Ethel Bernal, Regulatory Affairs Manager
Date prepared:	February 25, 2008
Trade name:	Sierra™
Common name:	Occipital plate
Classification name:	Spinal Interlaminal Fixation OrthosisKWP (Class II) – 888 3050

Substantial equivalence claimed to:

The devices used for comparison in this summary are SeaSpine, Inc. 's Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229).

The overall design of the occipital plates in this submission is substantially equivalent to the predicate devices.

Description:

Intended use: (The statements of intended use are identical.)

The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

devenerative disc disease (DDD) as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis. .
trauma (i.e., fracture or dislocation), .
spinal stenosis, .
atlantoaxial fracture with instability, .
occipitocervical dislocation, .

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Sierra™M

revision of previous cervical spine surgery, and/or .
. spinal tumor.

The occipital bone screws are limited to occipital fixation only.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Summary of technological characteristics:

The occipital plates in this notification are components of SeaSpine's stand alone occipitocervico-thoracic spinal fixation system called Sierra. The addition of the new devices has not altered the fundamental scientific technology of the previously cleared system. The devices in this submission have substantially equivalent technological characteristics to the predicate devices.

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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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2008

SeaSpine, Inc. % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, CA 92081-7862

Re: K080526

Trade/Device Name: Sierra™ OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 27, 2008 Received: March 28, 2008

Dear Ms. Bernal:

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 - Ms. Ethel Bernal

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. Millican

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 Statement

6080526 510(k) Number (if known):

Device Name: Sierra

Indications for Use:

The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

degenerative disc disease (DDD) as defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis, .
trauma (i.e., fracture or dislocation), ●
spinal stenosis, .
atlantoaxial fracture with instability, .
occipitocervical dislocation, .
revision of previous cervical spine surgery, and/or ◆
spinal tumor. .

The occipital bone screws are limited to occipital fixation only.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Prescription Use AND/OR Over-The-Counter-Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(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 General, Restorative, and Neurological Devices

510(k) Number_K080526

Page 1 of 1

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.