The Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

Device Description

The Solus Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral body fusion system for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Solus System consists of implants with various sizes and heights available in 7º or 12º lordosis to accommodate individual patient pathology. The implants are manufactured from polyetheretherkeytone (PEEK Optima LT)) material conforming to ASTM F2026 and tantalum radiographic markers (ASTM F560) with internal anchoring blades of titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136.

AI/ML Overview

The provided text describes the Solus Anterior Lumbar Interbody Fusion (ALIF) System, a medical device for spinal fusion. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information, specifically addressing the requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Solus ALIF System)
Mechanical Performance	Substantially Equivalent to Predicate Devices
Axial Compression	Testing performed per ASTM 2077-03.
Dynamic Compression	Testing performed per ASTM 2077-03.
Static Compression-Shear	Testing performed per ASTM 2077-03.
Static Torsion	Testing performed per ASTM 2077-03.
Dynamic Torsion	Testing performed per ASTM 2077-03.
Subsidence	Testing performed per ASTM 2267.
Static Push-Out	Testing performed per draft standard ASTM F-04.25.02.02.
Cadaveric Fatigue (Flexion)	Testing performed.
Cadaveric Fatigue (Lateral Bending)	Testing performed.
Cadaveric Fatigue (Axial Rotation)	Testing performed.
Blade/Vertebral Body Interface	Finite Element Analysis performed.
Overall Conclusion	"The test results demonstrate that the mechanical performance of the Solus Anterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numerical sample sizes for each mechanical test performed. For instance, it mentions "cadaveric fatigue testing" but doesn't specify the number of cadavers or specimens used. The provenance of the test data (e.g., country of origin, retrospective or prospective) is also not specified, though it would typically be internal testing by the manufacturer or contracted labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and is not provided in the document. The "ground truth" for this type of device (spinal implant) is established through standardized mechanical testing according to ASTM standards, not through expert consensus on medical images or patient outcomes in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This is not applicable as the "ground truth" is established through engineering and mechanical testing, not through human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Solus ALIF System is a physical implant, and its performance is assessed through mechanical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable. The Solus ALIF System is a physical medical device, not an algorithm. Its "standalone performance" refers to its mechanical integrity and function as tested in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for the Solus ALIF System's performance is established through standardized mechanical testing. This includes:

Physical testing according to ASTM standards (e.g., ASTM 2077-03 for axial compression, dynamic compression; ASTM 2267 for subsidence; draft standard ASTM F-04.25.02.02 for static push-out).
Cadaveric fatigue testing.
Finite Element Analysis (FEA) for the blade/vertebral body interface.

The performance is then compared to predicate devices to demonstrate substantial equivalence, implying that the established "ground truth" for the predicate devices (which have been deemed safe and effective) serves as the benchmark.

8. The Sample Size for the Training Set

This is not applicable. The Solus ALIF System is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no "training set" for this type of device.

Summary

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

K102402

MAR 3 0 2011

510(k) Summary Alphatec Spine, Inc.

Alphatec Spine

Solus Anterior Lumbar Interbody Fusion (ALIF) System

510(k) SUMMAR Y March 2011

Company:	Alphatec Spine, Inc.5818 El Camino RealCarlsbad, CA 92008 USADirect: (760) 494-6739Fax: (760) 431-0289
Contact Person:	Karla Schaffner, Regulatory Affairs Submission Specialist
Trade/Proprietary Name:	Solus Anterior Lumbar Interbody Fusion (ALIF)System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device
Classification Number(s):	21 CFR 888.3080
Product Code(s):	MAX

Product Description:

Indications for Use:

The Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Solus implant is intended to be used with autografi. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

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

Image /page/1/Picture/0 description: The image shows the logo for Alphatec Spine. The logo features a stylized lowercase Greek letter alpha above the words "Alphatec Spine" in a bold, italicized font. The logo is black and white.

Substantial Equivalence:

The Solus Anterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to the following predicate devices:

System	Clearance	Date
Incite Innovations Fusions Device	K093808	March 24,2010
LDR ROI-A	K080572	June 25, 2009
Synthes Spine SynFix LR Spacer	K072253	October 12, 2007
Novel Anterior Lumbar Interbody Fusion (ALIF)System	K090782	April 22, 2009

Data was provided which demonstrated the Solus Anterior Lumbar Interbody Fusion (ALIF) System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, intended use, design, material, and function.

Performance Data:

Testing was performed per ASTM 2077-03 for axial compression, dynamic compression, static compression-shear, static torsion, and dynamic torsion testing of intervertebral fusion devices. Testing was performed per ASTM 2267 for subsidence testing of intervertebral fusion devices. Testing was performed per the draft standard ASTM F-04.25.02.02 for static push-out testing. Cadaveric fatigue testing was performed in Flexion, Lateral Bending and Axial Rotation. Finite element analysis was performed to evaluate the blade /vertebral body interface. The test results demonstrate that the mechanical performance of the Solus Anterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to the predicate devices.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle. The text is in a simple, sans-serif font.

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

Alphatec Spine, Inc. % Ms. Karla Schaffner Regulatory Affairs Submissions Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K102402

Trade/Device Name: Solus Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 18, 2011 Received: March 21, 2011

SEP 12 . 01

Dear Ms. Schaffner:

This letter corrects our substantially equivalent letter of March 30, 2011.

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 (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 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

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

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Millikan

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

Enclosure

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

Image /page/4/Picture/0 description: The image shows the Greek letter alpha in a cursive font. Below the letter, the word "Alphatec" is printed in a bold, sans-serif font. To the right of "Alphatec" are some numbers, specifically 3,549.

510(k) #K102402 Alphatec Spine, Inc. Solus Anterior Lumbar Interbody Fusion (ALIF) System

INDICATIONS FOR USE

510(k) Number (if known): K102402

Device Name: Solus Anterior Lumbar Interbody Fusion (ALIF) System

Indications for Use:

The Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K102402 510(k) Number.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.