The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.

When used as a Vertebral Body Replacement Device:

The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or tumor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

Device Description

The Met 1 Technologies Virtu C Spinal Intervertebral Body Fusion Device is a cervical intervertebral body fusion device that is implanted into the invertebral body space to improve stability of the spine while supporting fusion. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

The Met 1 Technologies Virtu C Spinal Vertebral Body Replacement Device is a thoracolumbar vertebral body replacement device that is implanted to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

AI/ML Overview

The provided document is a 510(k) summary for the Virtu C Spinal Implant, a medical device for spinal fusion and vertebral body replacement. This document primarily focuses on demonstrating substantial equivalence to predicate devices, and therefore does not contain information about a study proving device performance against acceptance criteria in the typical sense of a clinical or image-based AI study with metrics like sensitivity, specificity, or AUC.

Instead, the "performance data" referred to in this document relates to mechanical testing of the implant. The acceptance criteria are implicit in the fact that the device "demonstrated substantial equivalence" to predicate devices through these mechanical tests.

Here's an breakdown of the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" due to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Static axial compression performance equivalent to predicate devices per ASTM F2077	Demonstrated substantial equivalence (passed test)
Static torsion performance equivalent to predicate devices per ASTM F2077	Demonstrated substantial equivalence (passed test)
Static subsidence performance equivalent to predicate devices per ASTM F2267	Demonstrated substantial equivalence (passed test)
Static expulsion performance equivalent to predicate devices per ASTM F-04.25.02.02	Demonstrated substantial equivalence (passed test)
Dynamic axial compression performance equivalent to predicate devices per ASTM F2077	Demonstrated substantial equivalence (passed test)
Dynamic torsion performance equivalent to predicate devices per ASTM F2077	Demonstrated substantial equivalence (passed test)

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

Sample Size: Not specified for the mechanical tests, but typically involves a set number of physical implant samples per test. This is not a "test set" in the context of clinical AI/imaging data.
Data Provenance: Not applicable. These are mechanical laboratory tests of physical devices, not data derived from patients or real-world usage.

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

Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not through expert clinical consensus.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical test results are quantitative and objective, typically not requiring subjective adjudication.

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

MRMC Study: No, this document does not describe an MRMC study. This type of study is relevant for diagnostic imaging devices or AI algorithms that assist human readers, not for purely mechanical implants.
Effect Size of Human Reader Improvement: Not applicable.

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

Standalone Performance Study: No, this document does not describe a standalone performance study. This term is typically used for AI algorithms. The "performance data" here refers to the mechanical performance of the physical implant.

7. The Type of Ground Truth Used

Type of Ground Truth: For the mechanical tests, the "ground truth" (or reference standard) is the established performance characteristics and safety profiles of the identified predicate devices, as well as the specifications and limits defined by the relevant ASTM test standards (e.g., F2077, F2267). The device being tested must perform equivalently to these standards and predicates.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This is not an AI or machine learning device that requires a training set.

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

Ground Truth Establishment: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of mechanical performance tests conducted on the Virtu C Spinal Implant System. These tests are:

Static axial compression per ASTM F2077
Static torsion per ASTM F2077
Static subsidence per ASTM F2267
Static expulsion per ASTM F-04.25.02.02
Dynamic axial compression per ASTM F2077
Dynamic torsion per ASTM F2077

The document states that the device was tested in these modes and "demonstrated substantial equivalence" to the predicate devices. This implies that the results of these tests fell within acceptable limits defined by the ASTM standards and were comparable to the known performance of the predicate devices. The acceptance criteria are, therefore, implicitly tied to meeting the performance characteristics of the legally marketed predicate devices and adhering to the specifications of the referenced ASTM standards. No specific raw data or quantitative results from these tests are provided in this 510(k) summary, only the conclusion that substantial equivalence was demonstrated.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human figure in profile, with three overlapping faces.

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

November 9, 2016

Met 1 Technologies, LLC % Mr. Kenneth C. Maxwell Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K161649

Trade/Device Name: Virtu C Spinal Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: October 3, 2016 Received: October 6, 2016

Dear Mr. Maxwell:

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. Isting 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

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

510(k) Number (if known) K161649 Device Name

Virtu C Spinal Implant

Indications for Use (Describe)

When used as an Intervertebral Body Fusion Device:

When used as a Vertebral Body Replacement Device:

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

区 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)

FORM FDA 3881 (9/13)

PSC Publishing Services (301) 443-6740 EB

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510(K) SUMMARY

Submitter's Name:	Met 1 Technologies, LLC
Submitter's Address:	154 N. Festival Dr., Ste. FEl Paso, TX 79912
Submitter's Telephone:	915.301.0834
Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.337.7579
Date Summary was Prepared:	09 November 2016
Trade or Proprietary Name:	Virtu C Spinal Implant
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, CervicalSpinal Vertebral Body Replacement System
Classification:	Class II per 21 CFR §888.3080Class II per 21 CFR §888.3060
Product Code:	ODP, MQP
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

When used as an Intervertebral Body Fusion Device:

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When used as a Vertebral Body Replacement Device:

The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or turnor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:

. Indications for Use
Materials of manufacture ●
Principle of operations

Table 5-1: Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	PredicateType
K112036	Calix™ Spinal Implant System	X-Spine Systems	Primary
K083637	Calix™ Spinal Implant System	X-Spine Systems	Reference
K142205	X-CORE® Expandable VBR System	NuVasive	Reference

PERFORMANCE DATA

The Virtu C Spinal Implant System has been tested in the following test modes and demonstrated substantial equivalence:

Static axial compression per ASTM F2077
Static torsion per ASTM F2077
. Static subsidence per ASTM F2267
Static expulsion per ASTM F-04.25.02.02 ●
Dynamic axial compression per ASTM F2077 ●
. Dynamic torsion per ASTM F2077

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Virtu C Spinal Implant System is substantially equivalent to the predicate device.

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.