The VIRTU Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthessis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the VIRTU Lumbar Spacer System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the VIRTU PLIF/TLIF System.

The VIRTU Lumbar Spacer System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Device Description

The VIRTU Posterior Lumbar Spacer System consists of implants, trials and instruments. The VIRTU Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.

AI/ML Overview

This document describes a 510(k) premarket notification for the "VIRTU Lumbar Spacer System", a medical device. As such, it does not present independent clinical studies or acceptance criteria for AI/ML device performance. Instead, it demonstrates substantial equivalence to predicate devices based on non-clinical performance data.

Therefore, many of the requested categories for AI/ML device performance (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to this submission.

However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them.

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

Based on the document, the acceptance criteria are implicitly tied to demonstrating performance "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices." While specific numerical acceptance criteria are not explicitly stated in the provided text, the device was tested against recognized ASTM standards. The reported device performance is that it met these standards and was found to be substantially equivalent.

Acceptance Criterion (Implicit)	Reported Device Performance
Static Axial Compression: Sufficient for intended use and substantially equivalent to predicate devices (per modified ASTM 2077-11)	Met the requirements, indicating sufficient strength for intended use.
Dynamic Axial Compression: Sufficient for intended use and substantially equivalent to predicate devices (per ASTM 2077-11)	Met the requirements, indicating sufficient strength for intended use.
Expulsion: Sufficient for intended use (per ASTM Draft Standard F-04.25.02.02)	Met the requirements, indicating stability.
Subsidence: Sufficient for intended use (per ASTM F2267)	Met the requirements, indicating acceptable resistance to subsidence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the mechanical tests. The data provenance is "non-clinical testing" conducted by the submitter (Met 1 Technologies, LLC). This is laboratory testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is mechanical testing to established engineering standards, not human expert consensus. The "ground truth" is adherence to the specified ASTM testing methodologies and achieving results comparable to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is mechanical testing, not a clinical trial with human disagreement.

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 spinal implant device, not an AI diagnostic tool.

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

Not applicable. This is a spinal implant device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data, the "ground truth" is adherence to established mechanical testing standards (ASTM standards) and the resultant data demonstrating the device's mechanical properties. The benchmark for "sufficient" is implied to be comparable performance to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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

August 1, 2016

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

Re: K160699

Trade/Device Name: VIRTU Lumbar Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 23, 2016 Received: June 27, 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, 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" (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 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) K160699

Device Name VIRTU Lumbar Spacer System

Indications for Use (Describe)

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the VIRTU PLIF/TLIF System.

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

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:	22 July 2016
Trade or Proprietary Name:	VIRTU Lumbar Spacer System
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080 Device Classification
Product Code:	MAX
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

INDICATIONS FOR USE

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the VIRTU PLIF/TLIF System.

The indications for use for the VIRTU Lumbar Spacer System is similar to that of the predicate devices listed in table 5-1.

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TECHNOLOGICAL CHARACTERISTICS

All implant components are manufactured from PEEK per ASTM F2026 and tantalum per ASTM F560. 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 identical between the subject and predicates:

. Indications for Use
Materials of Manufacture .
Structural Support Mechanism ●
. Principles of Operation

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K122097	PATRIOT™ Spacers	Globus MedicalInc.	Primary
K130573	Interbody System	Tyber Medical	Additional
K112095	AccuLiF® TL-PEEK Cageand AccuLiF® TL and PL	CoAlignInnovation	Additional
K113478	PLIF Cage	Eisertech	Additional

PERFORMANCE DATA

The VIRTU Lumbar Spacer System has been tested in the following test modes:

. Static axial compression per modified ASTM 2077-11
. Dynamic axial compression per ASTM 2077-11
Expulsion per ASTM Draft Standard F-04.25.02.02 ●
Subsidence per ASTM F2267

The results of this non-clinical testing show that the strength of the VIRTU Lumbar Spacer System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the VIRTU Lumbar Spacer 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.