When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Device Description

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

AI/ML Overview

This document is a 510(k) premarket notification for the SOLSTICE® OCT System, a spinal interlaminal fixation orthosis. The FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information provided (or lack thereof, as this is a 510(k) and not a clinical study report):

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from this document)	Reported Device Performance (from this document)
Mechanical Testing: Static and dynamic compression testing (No specific quantitative criteria provided).	The SOLSTICE OCT System successfully underwent static and dynamic compression testing.
Mechanical Testing: Benchtop rod lockup testing (No specific quantitative criteria provided).	The SOLSTICE OCT System successfully underwent benchtop rod lockup testing.
Material: Composed of titanium alloy (6AL-4V-ELI per ASTM F 136).	The SOLSTICE OCT System is 6AL-4V-ELI titanium manufactured according to ASTM F136.
Substantial Equivalence: Design, materials, indications for use, and sizing are substantially equivalent to predicate device.	The SOLSTICE OCT System is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing.

Important Note: This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed clinical performance metrics against predefined acceptance criteria for a novel device. Therefore, the acceptance criteria are largely related to mechanical performance and material specifications that demonstrate equivalence to the predicate, rather than clinical efficacy endpoints. Specific quantitative thresholds for static/dynamic compression and rod lockup are not provided in this document.

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

This document describes mechanical testing of the device, not a clinical test set with patient data.
The document does not specify the sample size for the mechanical tests (e.g., number of implant constructs tested).
Data provenance is not applicable as it's mechanical benchtop testing, not human patient data.

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

Not applicable. This pertains to mechanical testing, not clinical evaluation requiring expert ground truth for patient diagnoses or outcomes.

4. Adjudication method for the test set:

Not applicable. This pertains to mechanical testing.

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 document is for a spinal implant, which is a physical device, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant here.

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

Not applicable. This document is for a spinal implant, not a standalone algorithm.

7. The type of ground truth used:

For the mechanical testing, the "ground truth" would be the engineering specifications and standards (e.g., ASTM F136 for material, and potentially other industry standards for static/dynamic compression and rod lockup of spinal instrumentation). The device's performance is compared against these standards or the performance of the predicate device.

8. The sample size for the training set:

Not applicable. This document describes mechanical testing of a physical device, not a machine learning model that requires a training set.

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

Not applicable. As above, no training set for a machine learning model is involved.

Summary

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

Life Spine, Incorporate Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142

Re: K150229

Trade/Device Name: SOLSTICE® OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: February 12, 2015 Received: February 13, 2015

Dear Mr. Lewis:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

April 7, 2015

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Page 2 - Mr. Randy Lewis

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/Resourcesfor You/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/ReportaProblem/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.

Sincerely vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K150229

Device Name Solstice OCT System

Indications for Use (Describe)

When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary SOLSTICE® OCT System

Submitted By:	Life Spine, Inc.13951 S Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine, Inc.13951 S Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	March 30th, 2015
Trade Name:	SOLSTICE OCT System
Common Name:	Spinal interlaminal fixation orthosis
Classification:	KWP, CFR 888.3050, Class II
Predicate Device:	The Solstice OCT System (K120998)
Reference Device:	The Nautilus Spinal System (K132866) & (K073480)

Device Description:

Intended Use of the Device:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

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When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Technological Characteristics:

The SOLSTICE OCT System is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing.

Material:

The SOLSTICE OCT System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of a variety of non-sterile titanium, single use components.

Performance Data:

Mechanical Testing consisting of static and dynamic compression as well as benchtop rod lockup testing was presented to demonstrate the substantial equivalence of the SOLSTICE OCT System.

Conclusion:

The information presented demonstrates the substantial equivalency of The SOLSTICE OCT System.

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.