The Camber Spine Technologies SPIRA™ Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA™ Open Matrix ALIF system must be used with autogenous graft material.

Device Description

The Camber Spine Technologies SPIRA Open Matrix ALIF is an Interbody Fusion Device that has spiral support arches to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the SPIRA™ Open Matrix ALIF intervertebral body fusion device, based on substantial equivalence to predicate devices, rather than a clinical study evaluating its performance with human readers and AI assistance. Therefore, most of the requested information regarding acceptance criteria for AI performance in a clinical setting (e.g., sample size for test sets, experts for ground truth, MRMC studies, standalone performance) is not applicable to this document.

However, the document does contain information about the mechanical performance testing of the device for regulatory purposes. I can extract and present the relevant information that is available:

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

The document does not provide a specific table of acceptance criteria with numerical values and reported device performance. Instead, it states the following regarding mechanical testing against predicate devices:

Acceptance Criteria	Reported Device Performance
Defined by predicate device performance	Met

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

The document does not specify the sample size for the "test set" in terms of mechanical testing, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective). Mechanical testing typically uses a certain number of identical physical devices for each test, but this information is not explicitly provided in the summary.

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

This question is not applicable as the "ground truth" here pertains to mechanical properties of the device, not a diagnosis or interpretation requiring human expert readers.

4. Adjudication method for the test set

Not applicable, as this refers to human expert review for establishing ground truth, not mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This device is an implantable medical device, and the evaluation for its 510(k) clearance focused on demonstrating substantial equivalence in design, materials, function, manufacturing, and mechanical performance to existing predicate devices, not on a comparative effectiveness study involving human readers and AI assistance.

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

Not applicable. This is not an AI diagnostic or assistive device. "Standalone performance" would refer to the mechanical performance of the device itself, which was indeed tested.

7. The type of ground truth used

For the mechanical performance testing, the "ground truth" was established by standardized laboratory testing protocols (ASTM F2077-14 and F2267-04) and comparison to the performance of existing, legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device's regulatory submission, as it is not an AI/ML algorithm.

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

Not applicable, as there is no training set mentioned in the context of this device.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of a human figure.

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

June 12, 2017

Camber Spine Technologies % Justin Eggleton Senior Director, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K162986

Trade/Device Name: SPIRATM Open Matrix ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 8, 2017 Received: May 10, 2017

Dear Mr. Eggleton:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/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,

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)

K162986 Page 1 of 1

Device Name SPIRA™ Open Matrix ALIF

Indications for Use (Describe)

The Camber Spine Technologies SPIRA™ Open Matrix ALIF system must be used with autogenous graft material.

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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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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510(k) Summary

Device Trade Name:	SPIRA™ Open Matrix ALIF
Manufacturer:	Camber Spine Technologies418 E. Lancaster Ave.Wayne, PA 19087
Contact:	Mr. Michael BlackDirector of EngineeringPhone: (855) 899.9869
Prepared by:	Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800jeggleton@mcra.com
Date Prepared:	June 9, 2017
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	MAX
Primary Predicate:	4WEB Medical ALIF Spinal Truss System (K083894,K112316)
Additional Predicate(s):	Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFixAnterior Lumbar System (K132790, K143297), and Scient'xTribeca Cage (K080588).

Indications For Use:

The Camber Spine Technologies SPIRA Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix ALIF system must be used with autogenous graft material.

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Device Description:

Predicate Device:

The subject SPIRA Open Matrix ALIF device is substantially equivalent to predicates 4WEB Medical ALIF Spinal Truss System (K083894, K112316), Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient'x Tribeca Cage (K080588) with respect to indications, design, materials, function, manufacturing, and/or performance.

Performance Testing Summary:

Testing performed indicate that the SPIRA Open Matrix ALIF is as mechanically sound as predicate devices. Testing included static compression-static compression-shear, dynamic compression, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.

Substantial Equivalence:

The subject SPIRA Open Matrix ALIF device was demonstrated to be substantially equivalent to predicates 4WEB Medical ALIF Spinal Truss System (K083894, K112316), Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient'x Tribeca Cage (K080588) with respect to indications, design, materials, function, manufacturing, and/or performance.

Conclusion:

Camber Spine Technologies provided sufficient information to demonstrate the SPIRA Open Matrix ALIF is substantially equivalent to predicates 4WEB Medical ALIF Spinal Truss System (K083894, K112316), Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient'x Tribeca Cage (K080588) with respect to indications, design, materials, function, manufacturing, and/or performance.

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.