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

Rod connectors, crossbars and set screws are being added to the Sierra spinal system. All products are fabricated from titanium alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

This document describes a 510(k) premarket notification for the Sierra™ spinal system, specifically referring to the addition of rod connectors, crossbars, and set screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or safety. Therefore, the provided information does not include details on acceptance criteria, a study proving performance against those criteria, or specific metrics like sensitivity, specificity, or reader improvement with AI.

Here's an analysis based on the provided text, highlighting the absence of the requested information due to the nature of a 510(k) submission:

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

Acceptance Criteria: Not explicitly stated as performance metrics in the provided document. For 510(k) submissions, the “acceptance criteria” typically revolve around demonstrating substantial equivalence in terms of functionality, technological characteristics, and safety to a predicate device. This is often achieved through comparative testing (e.g., mechanical, material) and analysis rather than clinical performance metrics.
Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the new components have "substantially equivalent technological characteristics to the predicate devices."

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/not provided. This document does not describe a clinical study in the traditional sense involving a "test set" of patients or data for performance evaluation. The "testing" likely involved mechanical and material characterization of the new components against established standards or predicate device specifications.
Data Provenance: Not applicable/not provided.

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/not provided. Ground truth establishment by medical experts is typically part of clinical performance studies, which are not detailed in this 510(k) submission.

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

Not applicable/not provided. Adjudication methods are relevant for clinical studies that involve expert review of cases, which is not the focus of this document.

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

MRMC Study: No. This document concerns a conventional medical device (spinal fixation system components), not an AI-powered diagnostic or assistive tool.
Effect size of human reader improvement with AI: Not applicable, as no AI component is described.

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

Not applicable, as no algorithm or AI component is described.

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

Not applicable. The "ground truth" for a 510(k) submission like this would involve demonstrating that the new components meet established engineering and material standards, and perform comparably to predicate devices in mechanical and functional tests. It is not about clinical ground truth derived from patient data.

8. The sample size for the training set

Not applicable. There is no mention of an algorithm or AI requiring a training set.

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

Not applicable. There is no mention of an algorithm or AI requiring a training set or ground truth establishment in this context.

Summary of what the document does provide:

Predicate Devices: SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229).
Basis for Equivalence: "The overall designs of the rod connectors, crossbars and set screws in this submission are substantially equivalent to the predicate devices." and "The devices in this submission have substantially equivalent technological characteristics to the predicate devices."
Materials: All products are fabricated from titanium alloy.
Intended Use: Promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and spinal tumor).
Limitations: Occipital bone screws limited to occipital fixation; polyaxial screws limited to T1-T3 for thoracic conditions only, not for cervical spine.

In conclusion, this document is a 510(k) summary for a conventional medical device modification, which focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting clinical study results with performance metrics or AI algorithm validation.

Summary

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K072729

Page 1 of 2

APR 1 7 2008

CONFIDENTIAL

Sierra™M

Special 510(k) Summary

Submitter:	SeaSpine Inc.2302 La Mirada Dr.Vista, CA 92081Phone: (760) 727-8399Fax: (760) 727-8891
Contact person:	Ethel Bernal, Regulatory Affairs Manager
Date prepared:	September 25, 2007
Trade name:	SierraTM
Common name:	Rod connectors, crossbars, set screws
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 designs of the rod connectors, crossbars and set screws in this submission are 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:

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, .

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

K072729

Sierra™

Page 2 of 2

CONFIDENTIAL

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 rod connectors, crossbars and set screws in this notification are components of ScaSpine's stand alone occipito-cervico-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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2008

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

Re: K072729

Trade/Device Name: SierraTM Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: April 14, 2008 Received: April 19, 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 (OS) 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 M Milliman

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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K072729

Page 1 of 1

Indications for Use Statement

K072729 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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Orl fwrnxn

Division of General, Restorative, and Neurological Devices

510(k) Number K072729

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.