The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

Device Description

The CBx screws are to be included in the currently marketed Arsenal Spinal Fixation System which is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of screws, rods, and connectors that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The CBx screws are made of Titanium Alloy (Ti 6Al 4V ELI) and are designed for placement in the cortical areas of the pedicle where the bone is typically harder, stronger and stiffer than the cancellous portion of the pedicle/vertebra. The threadform of the CBx screws allows the surgeon to use the screw that best suits the patient's anatomy where either cortical bone or both cortical bone and cancellous bone are present.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Arsenal Spinal Fixation System," specifically introducing CBx screws as part of this system. This document is focused on demonstrating substantial equivalence to predicate devices for a medical device (pedicle screw system), not an AI or software device.

Therefore, the information typically requested in an acceptance criteria and study section for an AI/software device (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document. The document describes mechanical performance testing to prove substantial equivalence for a physical medical implant.

However, I can extract the relevant performance data and acceptance criteria as presented in the document concerning the mechanical aspects of the device.

Acceptance Criteria and Device Performance for the Arsenal™ Spinal Fixation System (CBx screws)

The document focuses on demonstrating substantial equivalence of the CBx screws to existing predicate devices (Zodiac Spinal Fixation System, K100685, and Arsenal Spinal Fixation System, K133221) based on mechanical performance. The "acceptance criteria" are implied by the performance of the predicate devices and the relevant ASTM standards, where the CBx screws must perform equivalently.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Standard	Required Performance	Reported Device Performance (CBx screws)
ASTM F1717 - Static Compression Bending Test	Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems).	Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws.
ASTM F1717 - Dynamic Compression Bending Test	Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems).	Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws.
ASTM F1717 - Static Torsional Test	Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems).	Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws.
ASTM F1798 - Flexion extension moment (My)	Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems).	Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws.
ASTM F1798 - Flexion extension moment fatigue run out (My)	Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems).	Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws.

Study Description:

The study conducted was a mechanical performance testing program, rather than a clinical or AI performance study.

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

Sample Size: Not explicitly stated in terms of number of physical screws tested. The document generally refers to "the CBx screw" undergoing testing. Typically, mechanical tests for medical devices involve a statistically significant number of samples, but the exact count is not provided here.
Data Provenance: The tests were conducted to specific ASTM standards (ASTM F1717 and ASTM F1798). The data originates from laboratory mechanical testing of the physical device components. Country of origin for the data is not specified, but it would have been generated in a testing facility. The nature of the testing is by definition prospective for the device being evaluated, as the tests are performed on newly manufactured devices to assess their properties.

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

Not applicable. This relates to mechanical performance, not diagnostic interpretations or clinical outcomes requiring human expert "ground truth." The "ground truth" is defined by the objective physical properties and performance metrics measured according to established engineering standards.

4. Adjudication method for the test set:

Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for 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 is a physical medical device, not an AI system or diagnostic tool used by human readers.

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

Not applicable. This is a physical medical device, not an independent algorithm.

7. The type of ground truth used:

For mechanical performance, the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, as outlined by the specified ASTM standards. The performance of the predicate devices under the same tests serves as the benchmark for "substantial equivalence."

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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

January 5, 2015

Alphatec Spine. Incorporated Ms. Renée L. Murphy Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K143149

Trade/Device Name: ArsenalTM Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH Dated: December 5, 2014 Received: December 8, 2014

Dear Ms. Murphy:

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

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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 yours,

Lori A. Wiggins -S

for 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)

K143149

Device Name Arsenal Spinal Fixation System

Indications for Use (Describe)

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

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

I. SUBMITTER

Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Phone: (760) 431-9286 Fax: (760) 431-0289

Contact Person: Renée L. Murphy Date Prepared: December 4, 2014

II. DEVICE

Name of Device: Arsenal™ Spinal Fixation System Common or Usual Name: Pedicle Screw System Classification Name: Pedicle screw spinal system (21 CFR 888.3070) Regulatory Class: III Product Code: NKB, OSH, MNI, MNH

III. PREDICATE DEVICE

Zodiac Spinal Fixation System, K100685 (Primary Predicate) Arsenal Spinal Fixation System, K133221

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The technological design features of the CBx screws are similar to the predicate screws of the Zodiac and Arsenal Spinal Fixation Systems. Both are pedicle screw systems and are intended for posterior non-cervical screw fixation as an adjunct to fusion. The CBx screws are also similar to the predicates in that they have the same technical characteristics in terms of design. materials, threadform, componentry and assembly.

The differences between the subject CBx screws and the predicates are minor and do not raise any new or different questions regarding safety and effectiveness.

VII. PERFORMANCE DATA

The following mechanical performance information is being provided in support of a substantial equivalence determination.

The CBx screw and the predicates underwent mechanical performance testing per "Guidance for Industry and FDA Staff: Spinal Systems 510(k) 's, Mav 3, 2004. Specific tests that were conducted for which a determination of substantial equivalence is claimed are listed on the next page:

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ASTM F1717

Static Compression Bending Test ●
Dynamic Compression Bending Test ●
Static Torsional Test ●

ASTM F1798

Flexion extension moment (My) ●
Flexion extension moment fatigue run out (Mv) ●

Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws.

VII. CONCLUSION

Based upon the information provided in this Special 510(k) submission, it has been determined that the CBx screw is substantially equivalent to the predicate devices in regards to the following:

Indications for Use,
Fundamental Scientific Technology, ●
Materials.
Labeling and packaging, and ●
Performance Characteristics. ●

The CBx screw and the predicates were subjected to the same tests using the same methods under the same conditions. The CBx test results and analysis demonstrate substantial equivalence to the predicate devices.

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.