The VertebraLINK Fusion Platform is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Device Description

The VertebraLINK Fusion Platform is a comprehensive suite of generally box shaped devices which can be implanted into the prepared disc space when performing an intervertebral body fusion. The devices are manufactured from Invibio's PEEK Optima LT1 or PEEK Optima HA Enhanced per ASTM F2026. The devices contain a central axial opening for packing of bone graft material as well as teeth on the inferior and superior surfaces to resist expulsion. The platform will be offered in multiple lengths, widths, heights and lordoses to accommodate varying anatomies, pathologies, surgeon preferences, or techniques (i.e., TLIF, PLIF, or Oblique PLIF). Additionally, the device contains radiographic markers made from tantalum per ASTM F560.

AI/ML Overview

The provided document is a 510(k) summary for the VertebraLINK Fusion Platform, an intervertebral body fusion device. While it indicates that performance testing was conducted, it does not provide specific acceptance criteria or the detailed results (performance data) that would allow for the completion of the requested table. It only states that the results "show that the strength of the VertebraLINK Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Therefore, based solely on the provided text, I cannot fill in the table of acceptance criteria and reported device performance. Additionally, most of the other requested information regarding the study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this regulatory document, as it focuses on demonstrating substantial equivalence through non-clinical testing.

Here's what can be extracted and noted about the unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that testing was completed, but does not provide specific numerical acceptance criteria or the quantitative reported performance of the device against those criteria. It only offers a general conclusion of sufficiency and substantial equivalence.

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

Sample size for test set: Not specified. The performance data section refers to "the results of this non-clinical testing," but does not mention the number of samples or devices tested for each type of test.
Data provenance: Not explicitly stated, as these are non-clinical (mechanical) tests rather than clinical studies with 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 information is relevant for studies involving human interpretation (e.g., radiological reads for AI diagnostics). The provided document describes premarket non-clinical mechanical testing, not a study involving experts to establish ground truth for a diagnostic output.

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

Not applicable. As above, this pertains to studies involving human interpretation or clinical decision-making.

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. The document describes non-clinical mechanical performance testing of an intervertebral fusion device, not an AI-enabled diagnostic device requiring human reader assessment.

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

Not applicable. This device is an implantable medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance tests mentioned (Static axial compression, Dynamic axial compression, Expulsion, Subsidence, Bacterial Amebocyte Lysate) are indeed "standalone" in the sense that they evaluate the device itself without human interaction or a system loop, but this is a different context than what is typically implied by "standalone algorithm performance."

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

For the non-clinical mechanical tests, the "ground truth" would be defined by engineering standards and specifications (e.g., specific load requirements, displacement limits, or bacterial count thresholds outlined in the ASTM and AAMI standards referenced). There isn't a "ground truth" in the clinical sense of a disease state.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set. The performance testing described is for physical characteristics.

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

Not applicable. As this is not an AI algorithm requiring a training set, this question is not relevant.

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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.

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

March 29, 2017

FacetLINK dba LINKSpine % Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K162693

Trade/Device Name: VertebraLINK Fusion Platform Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 3, 2017 Received: March 8, 2017

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 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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K162693 Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
Indications for Use	See PRA Statement on last page.
510(k) Number (if known)	K162693
Device Name	VertebraLINK Fusion Platform
Indications for Use (Describe)	The VertebraLINK Fusion Platform is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
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)
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)
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

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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"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."

FORM FDA 3881 (9/13)

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510(K) SUMMARY

Submitter's Name:	FacetLINK dba LINKSpine
Submitter's Address:	101 Roundhill DriveRockaway, NJ 07866
Submitter's Telephone:	973.627.4171
Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874
Date Summary was Prepared:	23 March2016
Trade or Proprietary Name:	VertebraLINK Fusion Platform
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

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510k Number	Trade or Proprietary orModel Name	Manufacturer	Predicate Type
K130573	Interbody System	Tyber Medical	Primary
K112095	AccuLiF® TL-PEEK Cageand AccuLiF® TL and PL	CoAlign Innovation	Additional
K113478	PLIF Cage	Eisertech	Additional
K151785	Px HATM PEEK IBFSystem	Innovasis	Reference

Table 5-1: Predicate Devices

PERFORMANCE DATA

The following testing has been completed as part of the VertebraLINK Fusion Platform submission:

. Static axial compression per ASTM F2077
Dynamic axial compression per ASTM F2077 ●
Expulsion per ASTM Draft Standard F-04.25.02.02 ●
. Subsidence per ASTM F2267
. Bacterial Amebocyte Lysate (LAL) testing per AAMI ST72

The results of this non-clinical testing show that the strength of the VertebraLINK Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

TECHNOLOGICAL CHARACTERISTICS

The following technological characteristics are similar between the VertebraLINK Fusion Platform and the predicate devices:

Principles of Operation ●
Indications for Use
Materials ●
Sterility ●
Dimensional Features ●

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the VertebraLINK Fusion Platform 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.