The Battalion Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) 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

The Battalion Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft or autograft (e.g., Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Device Description

The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are available in the following two material varieties:

Polyetheretherketone (PEEK) with tantalum markers
Commercially pure titanium coated polyetheretherketone (PEEK) with tantalum markers. .

All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580. All implants are provided sterile.

This system includes inserter instruments used to set the implants between the vertebrae. The patient contacting portions of these instruments are made of surgical grade stainless steel (17Cr-4Ni) per ASTM A564/A564M. These instruments are provided non-sterile and are intended to be cleaned and steam sterilized before each use.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Battalion Universal Spacer System." It's a submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance data (mechanical testing and a cadaver study) rather than specific acceptance criteria for a diagnostic/AI device. Therefore, a table for "acceptance criteria and reported device performance" as typically seen for AI devices (e.g., sensitivity, specificity, AUC) is not directly applicable.

However, the "acceptance criteria" here relate to the device's mechanical integrity and biological safety, as demonstrated through adherence to specific ASTM standards and FDA guidance. The "device performance" refers to the results of these tests.

Acceptance Criteria (Demonstrated Adherence)	Reported Device Performance
Mechanical Testing:
Dynamic and Static Axial Compression	Acceptable performance characteristics demonstrated
Dynamic and Static Axial Torsion	Acceptable performance characteristics demonstrated
Dynamic and Static Shear (per ASTM F2077, including Wear Particulate Analysis)	Acceptable performance characteristics demonstrated
Static Expulsion Testing (per ASTM F-04.25.02.02)	Acceptable performance characteristics demonstrated
Static Subsidence Testing (per ASTM F2267)	Acceptable performance characteristics demonstrated
Surgical Technique Validation:
Surgical technique and implantation validation (cadaver study)	Validated
Biological Safety:
Bacterial Endotoxin Testing (BET) (per ANSI/AAMI ST72)	Endotoxin levels are within acceptable limits

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

Test Set Sample Size: Not applicable in the context of this device's non-clinical testing. The "test set" here refers to the samples used for mechanical and biological testing (e.g., individual implants for mechanical tests, cadavers for the cadaver study). Specific numbers are not provided in the summary.
Data Provenance: Not explicitly stated for the cadaver study or the materials used in mechanical testing. The document is for a medical device (spinal spacer system), not a diagnostic or AI product, so traditional "data provenance" like country of origin for patient data is not relevant here. The studies are non-clinical.

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

Not applicable. This device is a physical implant, and its performance is evaluated through mechanical and cadaveric studies, not through expert-labeled ground truth like in an AI diagnostic study. The "ground truth" for mechanical testing is established by the defined ASTM standards and measurements, and for biological safety by the BET standard. The cadaver study would involve surgeons, but their role is for surgical technique validation, not "ground truth establishment" in the sense of a diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert opinions (like 2+1, 3+1 for imaging reads). The evaluations are based on objective physical measurements and established biological safety protocols.

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:

No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI diagnostic tool that assists human readers.

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

No, a standalone algorithm performance study was not done. This is a physical medical device.

7. The Type of Ground Truth Used:

For this type of device, the "ground truth" is established by:

Engineering Standards: For mechanical performance, the ground truth is defined by the requirements and measurement methods outlined in the cited ASTM standards (e.g., F2077, F-04.25.02.02, F2267). The device performs as expected if it meets these quantifiable engineering criteria.
Biological Safety Standards: For bacterial endotoxin, the ground truth is defined by the acceptable limits specified in ANSI/AAMI ST72.
Surgical Feasibility/Technique Validation: For the cadaver study, the ground truth relates to the successful and appropriate implantation of the device according to surgical principles and the company's intended technique.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

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

September 8, 2016

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

Re: K160958

Trade/Device Name: Battalion Universal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: PHM, MAX Dated: August 10, 2016 Received: August 11, 2016

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 Parts 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" (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 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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160958

K160958 Page 1 of 2

Device Name Battalion Universal Spacer System

Indications for Use (Describe)

The Battalion Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

The Battalion Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft or autograft (e.g. Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:

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"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."

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4. 510(k) Summary

Device Trade Name	Battalion Universal Spacer System
Manufacturer	Alphatec Spine, Inc.
	5818 El Camino Real
	Carlsbad, CA 92008 USA
Contact	Renée L. Murphy
	Senior Regulatory Affairs Specialist
	Phone: (760) 494-6739
Date Prepared	September 1, 2016
Classifications	21 CFR §888.3080, Intervertebral Body Fusion Device
Class	II
Product Code	PHM, MAX
Predicate Device	Battalion Universal Spacer System (K143740) - Primary PredicateNuvasive CoRoent Thoracolumbar Implants (K150994)

Indications for Use

The Battalion Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

The Battalion Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft or autograft (e.g.,

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Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Device Description

Polyetheretherketone (PEEK) with tantalum markers
Commercially pure titanium coated polyetheretherketone (PEEK) with tantalum markers. .

Performance Data (non-clinical)

Mechanical testing performed in accordance with ASTM standards and FDA Spinal Guidance demonstrates acceptable performance characteristics for the modified implant designs. Testing includes Dynamic and Static Axial Compression: Dynamic and Static Axial Torsion, and Dynamic and Static Shear per ASTM F2077 (including Wear Particulate Analysis); Static Expulsion Testing per ASTM F-04.25.02.02; and Static Subsidence Testing per ASTM F2267.

A cadaver study was performed to validate the surgical technique and implantation of this device. Additionally, Bacterial Endotoxin Testing (BET) was conducted in accordance with ANSI/AAMI ST72 and demonstrated endotoxin levels that are within acceptable limits.

Clinical Information

Comprehensive, clinical literature reviews were conducted to assess the safety and efficacy of allograft used in conjunction with this device. This review concluded that there were no additional risks due to the modified indications for this device.

Technological Characteristics

The subject Battalion Universal Spacer System is similar to the predicate devices with respect to indications for use, design, materials, function, and performance.

Conclusion

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The information in this 510(k) demonstrates acceptable performance of the Battalion Universal Spacer System and substantial equivalence to the predicate devices.

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.