Indications for Use: It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.

Degenerative disk disease (DDD), defined as 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
Revision of previous cervical spine surgery
Tumors

Device Description

The SOLANAS™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and upper thoracic spine, C1-T3. There are a variety of implants that can be used for this procedure including cervical hooks, polyaxial pedicle screws and rods. All components are made from titanium alloy (ASTM F136).

AI/ML Overview

The provided text describes a medical device submission (K052201) for the SOLANAS™ Posterior Stabilization System, focusing on its substantial equivalence to a predicate device and its indications for use. It outlines the product description, classification, and regulatory disposition. However, it does not contain information related to specific acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any study results validating such performance in the context of an AI/ML device.

The document primarily focuses on:

Product Description: SOLANAS™ Posterior Stabilization System, made from titanium alloy, intended for cervical and upper thoracic spine stabilization.
Indications for Use: Degenerative disk disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, revision of previous cervical spine surgery, and tumors.
Substantial Equivalence: To the Summit™ system (K002733).
Performance Data: Mentions "Mechanical testing... was performed and submitted," but provides no details on the tests, criteria, or results. This is typical for mechanical devices where structural integrity and biocompatibility are key, not diagnostic accuracy.
Regulatory Approval: A 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested table or detailed information about acceptance criteria and study designs (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) because this document pertains to a mechanical spinal fixation system, not a device with performance metrics related to diagnostic accuracy, which is usually the context for the questions you've asked (e.g., sensitivity, specificity, comparison to human readers, ground truth establishment).

In summary, none of the requested information regarding acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) and detailed study methodologies for validating such performance are present in the provided text. The "Performance Data" mentioned refers to mechanical testing, not a clinical study assessing diagnostic or prognostic accuracy.

Summary

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Koszol.

SOLANAS™ Posterior Stabilization System 510(k) SUMMARY August 2005

NOV 1 0 2005

Alphatec Spine, Inc. l. Company: 2051 Palomar Airport Road Suite 100 Carlsbad, CA 92011, USA (760) 431-9286
Ellen Yarnall, Vice President of Compliance, ll Contact Person Regulatory Affairs and Quality Assurance
SOLANAS™ Posterior Stabilization System ||| Trade/Proprietary Name:

IV Product Description:

V. Classification

Pedicle Screw Spinal System KWP (21 CFR 888.3050) MNI (21 CFR 888.3070) Spinal Interlaminal Fixation Orthosis

VI Indications for Use

Degenerative disk disease (DDD), defined as neck pain of discogenic origin with 1. degeneration of the disc confirmed by history and radiographic studies.
1. Spondylolisthesis
1. Spinal stenosis
1. Fracture/Dislocation
1. Atlanto/Axial fracture with instability
Revision of previous cervical spine surgery റ.
1. Tumors

VII Substantial Equivalence:

The SOLANAS™ Posterior Stabilization System is substantially equivalent to Summit™ system (K002733).

VIII Performance Data:

Mechanical testing of the SOLANAS™ Posterior Stabilization System was performed and submitted in this application.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2005

Ellen A. Yarnall Vice President, RA/QA Alphatec Spine, Inc. 2051 Palomar Airport Road, Suite 100 Carlsbad, California 92011

Re: K052201

K052201
Trade/Device Name: SOLANAS™ Posterior Stabilization System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI Dated: October 27, 2005 Received: October 28, 2005

Dear Ms. Yarnall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications ferenced above und have acterimes ally marketed predicate devices marketed in interstate for use stated in the enclosure for regally manette to for the Medical Device Amendments, or to conninered proc to may 20, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 devices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dierelore, mains 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 If your device 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 r rease of a rised that I termination 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-Ellen A. Yarnall

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting 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

510(k) Number (if known): HOS 226)

Device Name: SOLANAS™ Posterior Stabilization System

Indications for Use:

1. Degenerative disk disease (DDD), defined as neck pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies.
1. Spondylolisthesis
1. Spinal stenosis
1. Fracture/Dislocation
1. Atlanto/Axial fracture with instability
1. Revision of previous cervical spine surgery
1. Tumors

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

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision of General, Restorative, no from ological Devices

) Number K052201

000012 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.