The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy Cage is indicated for use in the Thoracolumbar Spine (T1-L5) to replace collapsed, or an unstable vertebral body due to tumor or trauma (i.e., fracture). The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy Cage system must be used with autogenous graft material.

Device Description

The Camber Spine Technologies SPIRA-VIM Open Matrix Corpectomy Cage is a device that has spiral supports 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 document is a 510(k) premarket notification letter for a medical device called the "Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage." This document focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices. It does not describe an AI medical device or a study involving human readers or AI assistance.

Therefore, many of the requested criteria related to AI performance, human expert evaluation, and multi-reader multi-case studies are not applicable to this document.

However, I can extract information related to the device's performance testing and acceptance criteria as described in the summary:

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

Test Method	Acceptance Criteria	Reported Device Performance
Static Compression	Defined by predicate device performance (presumably, the device should be at least as strong as the predicate).	Met the acceptance criteria defined by predicate device performance.
Static Torsion	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Dynamic Compression	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Dynamic Torsion	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Subsidence	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Expulsion	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Particulate Analysis (ASTM F1877-16)	Not explicitly stated what the acceptance criteria were for particulate analysis, but it would involve limits on particle size and quantity.	Performed, and results demonstrate met criteria (implicit from the summary).

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

This document describes mechanical testing of a physical device, not an AI model or clinical data.
The "test set" in this context refers to the physical samples of the SPIRA-V™ Open Matrix Corpectomy Cage that underwent mechanical testing. The exact number of samples tested for each criterion is not specified in the provided text.
"Data provenance" is not applicable in the sense of patient data origin; instead, it would relate to how the physical test specimens were manufactured and handled, which is not detailed here.

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

Not applicable. This is a mechanical device, not an AI system requiring expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

Not applicable. No adjudication of human interpretations is involved as it's mechanical testing. The "ground truth" for mechanical properties is determined by the physical measurements themselves against established standards.

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 not an AI device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

For the mechanical tests, the "ground truth" is established through physical measurements against validated ASTM (American Society for Testing and Materials) standards and comparison to the mechanical performance of legally marketed predicate devices. The aim is to show the device is "as mechanically sound as predicate devices."

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

February 2, 2018

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

Re: K173800

Trade/Device Name: Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MOP Dated: December 13, 2017 Received: December 14, 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 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);

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Page 2 - Mr. Justin Eggleton

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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) K173800

Device Name

Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy Cage

Indications for Use (Describe)

The Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy Cage is indicated for use in the Thoracolumbar Spine (T1-L5) to replace collapsed, or an unstable vertebral body due to tumor or trauma (i.e., fracture). The Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy Cage 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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510(k) Summary

Device Trade Name:	Camber Spine Technologies SPIRA-VTM Open MatrixCorpectomy Cage
Manufacturer:	Camber Spine Technologies418 E. Lancaster Ave.Wayne, PA 19087
Contact:	Mr. Daniel PontecorvoCEOPhone: (484)-427-7060
Prepared by:	Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: (202) 552-5800jeggleton@mcra.com
Date Prepared:	January 23, 2018
Classifications:	21 CFR §888.3060, Spinal intervertebral body fixation orthosis
Class:	II
Product Codes:	MQP
Primary Predicate:	Camber Spine VERTA (K143490)
Additional Predicates:	Osteotech VBR (K012254), Interpore Geo Structure (K010530)
Reference Devices:	Camber Spine SPIRA-C Open Matrix Cervical Interbody(K172446), Rezaian Fixator (K841189)

Indications for Use:

The Camber Spine Technologies SPIRA-VI™ Open Matrix Corpectomy Cage is indicated for use in the Thoracolumbar Spine (T1-L5) to replace collapsed, damaged, or an unstable vertebral body due to tumor or trauma (i.e., fracture). The Camber Spine Technologies SPIRA-VIM Open Matrix Corpectomy is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy Cage system must be used with autogenous graft material.

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Device Description:

Predicate Device:

The subject Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy Cage is equivalent to the primary predicate device, Camber Spine VERTA (K143490). Additional predicates were presented, including the Osteotech VBR (K012254) and Interpore Geo Structure (K010530). Comparisons were made to reference devices. including the Camber Spine SPIRA-C Open Matrix Cervical Interbody (K172446) and Rezaian Fixator (K841189).

Performance Testing Summary:

Testing performed indicate that the Camber Spine Technologies SPIRA-V Open Matrix Corpectomy Cage is as mechanically sound as predicate devices. Testing included static compression, static torsion, dynamic compression, dynamic torsion, subsidence, and expulsion per ASTM F2077-14 and F2267-04. A particulate analysis was performed in accordance with ASTM F1877-16. The results demonstrate that the acceptance criteria defined by predicate device performance were met.

Substantial Equivalence:

The subject Camber Spine Technologies SPIRA-VI™ Open Matrix Corpectomy Cage is equivalent to the primary predicate device, Camber Spine VERTA (K143490) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional predicates were presented, including the Osteotech VBR (K012254) and Interpore Geo Structure (K010530). Comparisons were made to reference devices, including the Camber Spine SPIRA-C Open Matrix Cervical Interbody (K172446) and Rezaian Fixator (K841189).

Conclusion:

Camber Spine Technologies provided sufficient information to demonstrate the Camber Spine Technologies SPIRA-V Open Matrix Corpectomy Cage is equivalent to primary predicate, Camber Spine VERTA (K143490) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional predicates, Osteotech VBR (K012254) and Interpore Geo Structure (K010530), were presented for additional comparisons. Additional comparisons were made to other reference devices, including the Camber Spine SPIRA-C Open Matrix Cervical Interbody (K172446), Rezaian Fixator (K841189).

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.