The Solanas® Posterior OCT Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Solanas Posterior OCT Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Solanas Posterior OCT Fixation System may be connected to the components in the Zodiac® Polyaxial Spinal Fixation System, the Arsenal® Spinal Fixation System, or the Invictus™ Spinal Fixation System offered by Alphatec Spine using the Rod Connectors or Transitional Rods.

Device Description

The Solanas Posterior OCT Fixation System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracolumbar areas of the spine (Occiput-T3). The Solanas Posterior OCT Fixation System is comprised of two sub-systems: a cervical thoracic system (Solanas®) and an occipital cervical thoracic system (Solanas® Avalon®) which share many of the same implants and instruments. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy 1 (annealed and cold worked) and alloy 2 (warm worked) per ASTM F1537. The Solanas Posterior OCT System consists of a variety of shapes and sizes of screws, rods, hooks, bridges, connectors and general surgical instruments that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The implants are provided non-sterile to be steam sterilized by the end user. The Class I general instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

AI/ML Overview

The provided text is a 510(k) summary for the Alphatec Spine, Inc. Solanas® Posterior OCT Fixation System. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and technological comparisons, rather than AI/ML device performance or clinical studies with human readers.

Therefore, most of the requested information regarding acceptance criteria for AI/ML performance, study details for AI/ML models, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training sets is not applicable to this submission.

Here's a breakdown of what can be extracted from the document:

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

The document does not provide specific acceptance criteria or reported device performance in the format of a table as it pertains to AI decision-making. Instead, it refers to performance testing and engineering analysis for mechanical properties, demonstrating substantial equivalence to predicate devices. The "performance data" section states:

Acceptance Criteria (Implied / Mechanical): The previously presented mechanical testing data in predicate K173522 is sufficient to support the expanded indications for the Solanas system. This implies that the device must meet the mechanical performance standards established by the predicate device for:
- Static and Dynamic Compression Bending
- Static and Dynamic Torsion
- Axial Grip
Reported Device Performance: "Since no new device designs and no new worst case sizes are being introduced to the Solanas system, the previously presented mechanical testing data in predicate K 173522 is sufficient to support the expanded indications for the Solanas system." This indicates that the subject device's mechanical performance is considered equivalent to that demonstrated by the predicate and meets those established benchmarks without requiring new tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not an AI/ML device. The "test set" would refer to the mechanical testing conducted on the physical device components, not a dataset of images or patient information. The document does not specify sample sizes for mechanical testing, but confirms that prior testing on the predicate device (K173522) is relied upon.

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. This is not an AI/ML device. "Ground truth" in this context would relate to engineering standards and measurements from mechanical testing, not clinical expert consensus.

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

Not applicable. This is not an AI/ML device.

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 not an AI/ML device. The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

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

Not applicable. This is not an AI/ML device.

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

Not applicable. The "ground truth" for this medical device's clearance is based on engineering standards and mechanical testing results (Static and Dynamic Compression Bending, Static and Dynamic Torsion, Axial Grip) as compared to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 3, 2019

Alphatec Spine, Inc. Ms. Ruby Zheng Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K191185

Trade/Device Name: Solanas® Posterior OCT Fixation System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior cervical screw system Regulatory Class: Class II Product Code: NKG, KWP Dated: May 2, 2019 Received: May 3, 2019

Dear Ms. Zheng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191185

Device Name Solanas® Posterior OCT Fixation System

Indications for Use (Describe)

The Solanas Posterior OCT Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Solanas Posterior OCT Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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)
-----------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for "atec". The logo consists of a green square with rounded corners and a white stylized "a" inside. To the right of the square is the word "tec" in white, with a small "TM" symbol in the upper right corner.

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

I.	SUBMITTER:	Alphatec Spine, Inc.5818 El Camino RealCarlsbad, CA 92008Phone: (760) 431-6884Fax: (760) 431-0289
	Contact Person:	Ruby ZhengRegulatory Affairs SpecialistContact Phone: (760) 494-6884
	Date Summary Prepared:	May 2, 2019
II.	DEVICE
	Name of Device:	Solanas® Posterior OCT Fixation System
	Common or Usual Name:	Occipital Cervical Thoracic System
	Classification Name:	Posterior Cervical Screw System(21 CFR 888.3075)Spinal Interlaminal Fixation Orthosis(21 CFR 888.3050)

III. LEGALLY MARKETED PREDICATE DEVICES

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K153631	NKG, KWP	Zimmer Virage OCT SpinalFixation System	Zimmer Spine
Additional Predicate Device
K173522	NKB, KWP	Solanas Posterior StabilizationSystem	Alphatec Spine

Class II

NKG, KWP

DEVICE DESCRIPTION IV.

Regulatory Class:

Product Code:

The Solanas Posterior OCT Fixation System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracolumbar areas of the spine (Occiput-T3).

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for ATEC. The logo consists of a green square with a white stylized "a" inside of it, followed by the word "tec" in white. The background of the logo is a dark blue color.

The Solanas Posterior OCT Fixation System is comprised of two sub-systems: a cervical thoracic system (Solanas®) and an occipital cervical thoracic system (Solanas® Avalon®) which share many of the same implants and instruments.

The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy 1 (annealed and cold worked) and alloy 2 (warm worked) per ASTM F1537. The Solanas Posterior OCT System consists of a variety of shapes and sizes of screws, rods, hooks, bridges, connectors and general surgical instruments that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Since there have been no additional implants that were added to the system since last clearance in K173522, no additional mechanical testing is necessary in this submission.

The implants are provided non-sterile to be steam sterilized by the end user. The Class I general instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

V. INDICATIONS FOR USE

The Solanas® Posterior OCT Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Solanas Posterior OCT Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Solanas Posterior OCT Fixation System may be connected to the components in the Zodiac® Polyaxial Spinal Fixation System, the Arsenal® Spinal Fixation System, or the Invictus® Spinal Fixation System offered by Alphatec Spine using the Rod to Rod Connectors or Transitional Rods.

TECHNOLOGICAL COMPARISON TO PREDICATES VI.

The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the "atec" logo. The logo consists of a green square with rounded corners on the left side, with a white letter "a" inside the square. To the right of the square is the word "tec" in white letters, with a small trademark symbol above the "c".

VII. PERFORMANCE DATA

The purpose of this 510(k) is to modify the Indications for Use for the subject Solanas system to include the use of bone screws in the cervical spine and include the system's use with other Alphatec Spine pedicle screw systems, i.e., Zodiac Spinal Fixation System, Arsenal Spinal Fixation System and Invictus Spinal Fixation System. Predicate submissions of the subject Solanas Posterior OCT Fixation System included performance testing and engineering analysis to assess the Static and Dynamic Compression Bending, Static and Dynamic Torsion and Axial Grip. Predicate submissions of the subject Solanas Posterior OCT Fixation System included performance testing and engineering analysis to assess the Static and Dynamic Compression Bending, Static and Dynamic Torsion and Axial Grip.. Since no new device designs and no new worst case sizes are being introduced to the Solanas system, the previously presented mechanical testing data in predicate K 173522 is sufficient to support the expanded indications for the Solanas system.

Clinical Information

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

VIII. CONCLUSION

Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.