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 back 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

The Sierra spinal system will include polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component, and are being offered in a wide variety of sizes. All product is supplied "NON-STERILE" and must be sterilized prior to use.

Sierra will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with Radel and aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Sierra™ spinal system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, many of the requested categories regarding acceptance criteria, study details, ground truth, and training sets are not applicable to this type of regulatory submission. The document explicitly states: "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration."

Here's a breakdown of the available information:

Acceptance Criteria and Study Details for Sierra™ Spinal System

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

Since no clinical studies were performed to establish specific performance metrics or acceptance criteria for clinical outcomes, this cannot be provided as it would for a device relying on de novo clinical data. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The performance reported relates to mechanical strength per applicable standards.

Feature	Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Intended Use	Similar to predicate devices	Similar
Indications for Use	Similar to predicate devices	Similar
Design	Similar to predicate devices (Polyaxial screws, rods, etc.)	Similar
Polyaxial Screws	Similar to predicate devices (Various sizes)	Similar
Locking Cap	Similar to predicate devices (Various sizes)	Similar
Lateral Connectors	Similar to predicate devices (Various sizes)	Similar
Crossbars	Similar to predicate devices (Various sizes)	Similar
Occipital Plates	Similar to predicate devices (Various sizes)	Similar
Occipital Screws	Similar to predicate devices (Various sizes)	Similar
Hooks	Similar to predicate devices (Various sizes)	Similar
Rods	Similar to predicate devices (Various sizes)	Similar
Material	Similar to predicate devices (Titanium alloy and cobalt alloy)	Similar
Sterile	Non-sterile, similar to predicate devices	Non-sterile
Method of Sterilization	High-temperature steam, similar to predicate devices	Similar
Mechanical Strength	Passed testing per applicable standards	All products passed testing per applicable standards.

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

Not Applicable. No clinical test set or human data was used for this 510(k) submission. The evaluation was based on technological characteristics and mechanical testing.

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. No ground truth was established by external experts in the context of clinical performance or diagnostic accuracy. The substantial equivalence argument relies on comparison to existing legally marketed devices.

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

Not Applicable. No test set requiring adjudication was used.

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 a medical device (spinal system implants and instruments), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

Not Applicable. This is a medical device, not an algorithm. Therefore, no standalone performance study was conducted.

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

Not Applicable. As no clinical studies were performed, no ground truth based on clinical outcomes or expert consensus for a test set was established. The "ground truth" for the submission is the regulatory acceptance of the predicate devices whose characteristics the Sierra system mimics.

8. The sample size for the training set:

Not Applicable. No machine learning or AI models were used, so there was no training set.

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

Not Applicable. No machine learning or AI models were used, so there was no training set or ground truth establishment for such.

Summary

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NOV 16 2006

K06293Y

Sierra™

CONFIDENTIAL

510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

Submitter Information:	SeaSpine, Inc.Contact: Diana Smith2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Company Registration Number:	2032593
Submission Correspondent:	SeaSpine, Inc.Contact: Diana Smith, Manager ofRegulatory Affairs and Quality Assurance2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Date Summary Prepared:	September 25, 2006
Classification Name:	Pedicle Screw Spinal SystemMNI (Class II) - 888.3070(b)(1)Spinal Interlaminal Fixation OrthosisKWP (Class II) – 888.3050
Common/Usual Name:	Polyaxial screws, rods, locking caps,occipital plates, occipital screws, lateralconnectors, crossbars, hooks, components,and instruments
Device Trade Name:	Sierra™

The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).

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(The statements of intended use are identical.) 1. Intended 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 back 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.

2. Description:

3. Technological Characteristics:

The various implants and instruments in this notification are components of SeaSpine's new stand alone OCT spinal fixation system called, Sierra. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

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4. Comparison Analysis:

The overall designs of the polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components in this submission are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the Sierra polyaxial screws, rods, locking caps, occipital components, lateral connectors, contoured crossbars, hooks, and components to the predicate devices.

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Sierra™

Feature	Sierra	DePuy Acromed'sSummit andMountaineer OCTSpinal Systems	Interpore CrossInternational'sAltius OCT System	Medtronic SofamorDanek's VertexReconstructiveSystem	SubstantiallyEquivalent
Intended Use	The intended use of the Sierraspinal system is to promotefusion of the cervical spine andoccipito-cervico-thoracicjunction (occiput-T3).	Similar	Similar	Similar	Yes
Indications forUse	⚫degenerative disc disease(DDD) as defined by back painof discogenic origin withdegeneration of the discconfirmed by patient history andradiographic studies,⚫spondylolisthesis,⚫trauma (i.e., fracture ordislocation),⚫spinal stenosis,⚫atlantoaxial fracture withinstability,⚫occipitocervical dislocation,⚫revision of previous cervicalspine surgery, and/or⚫spinal tumor.	Similar	Similar	Similar	Yes
Design	Polyaxial screws, rods, lockingcaps, occipital plates, occipitalscrews, lateral connectors,crossbars, hooks, andcomponents.	Similar	Similar	Similar	Yes
PolyaxialScrews	Various sizes.	Similar	Similar	Similar	Yes
Locking Cap	Various sizes.	Similar	Similar	Similar	Yes
LateralConnectors	Various sizes.	Similar	Similar	Similar	Yes
Crossbars	Various sizes.	Similar	Similar	Similar	Yes
Occipital Plates	Various sizes.	Similar	Similar	Similar	Yes
OccipitalScrews	Various sizes.	Similar	Similar	Similar	Yes
Hooks	Various sizes.	Similar	Similar	Similar	Yes
Rods	Various sizes.	Similar	Similar	Similar	Yes
Material	Titanium alloy and cobalt alloy.	Similar	Similar	Similar	Yes
Sterile	Non-sterile	Similar	Similar	Similar	Yes
Method ofSterilization	High-temperature steam	Similar	Similar	Similar	Yes
MechanicalStrength	All products passed testing perapplicable standards.	Similar	Similar	Similar	Yes

Table 1: Summary of Design Comparison

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A financial certification or disclosure statement or both, as required by part 54 (i) of this chapter:
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration.
For submission claiming substantial equivalence to a device which has been (j) classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III Summary). The 510(K) submitter shall also ccrtify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807.94.

A Premarket Notification Class III Certification and Summary is not needed for this submission as the products under consideration are class II.

A statement that the submitter believes, to the best of his or her knowledge, (k) that all data and information submitted in the Premarket notification are truthful and accurate and that no material fact has been omitted.
A Premarket Notification Truthful and Accurate Statement is included on the following page.

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SeaSpine, Inc. % Ms. Ethel Bernal Document Control Specialist 2302 La Mirada Drive Vista, California 92081-7862

NOV 16 2006

Re: K062934

Trade/Device Name: SIERRA Regulation Number: 21 CFR 888.3070, 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: MNI, KWP Dated: September 25, 2006 Received: September 28, 2006

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For
Mark N. Melkerson
Director

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

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

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

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,
and Neurological Devices

510(k) Number	11062934
---------------	----------

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.