The VersaLink™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; tracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

Device Description

The VersaLink™ System consists of 6 Ti-6AI-4V main parts:

The VersaLink rod (the Rod); a spinal fixation rod with a dedicated ring end designed to enable robust attachment to the pedicle screw head above the crossbar.
Ring nut: dedicated nut designed to be tightened on the Ring Set Screw and firmly fix the VersaLinkTM Rod on the pedicle screw head.
VersaLink Ring Set Screw Torx: dedicated setscrews with double thread designed to allow attachment of the VersaLink™ Rod device to the head of the pedicle screw above the crossbar.
Crossbar rod: a bent rod designed to fit the average angle of the lumbar vertebra pedicles. It is horizontally attached to two pedicle screws on the same vertebra in order to reduce peak loads by better distributing the loads between the pedicle screws.
Polyaxial Pedicle screws
Torx Setscrew.

AI/ML Overview

The provided text is a 510(k) summary for the VersaLink™ Fixation System, a medical device for spinal fixation, and it discusses performance data related to mechanical testing, not a study involving human subjects or AI. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria and performance of a device proven through a study.

Specifically, the text details:

Device Name: VersaLink™ Fixation System
Intended Use/Indications for Use: To provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of various spinal instabilities and deformities.
Device Description: Components include a VersaLink rod, ring nut, VersaLink Ring Set Screw Torx, Crossbar rod, Polyaxial Pedicle screws, and Torx Setscrew, all made of Ti-6AI-4V.
Performance Data: "The VersaLink™ Fixation System was subjected to static compression, static torsion, and dynamic compression testing per ASTM F1717. All devices functioned and met their acceptance criteria."
Substantial Equivalence: The device is deemed substantially equivalent to a predicate device (ProMIS™ Fixation System) based on similar intended use, indications, materials, components, technological characteristics, and principles of operation.

The prompt, however, asks for details typically found in a clinical study or AI model validation, such as:

A table of acceptance criteria and the reported device performance: While the text states "All devices functioned and met their acceptance criteria" for mechanical tests, it does not provide the specific numerical acceptance criteria or reported performance values for these tests in a table format.
Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing of a physical device; there's no "test set" of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the ground truth is derived from the physical properties and behavior of the materials and design under specified loads, measured against established ASTM standards.
The sample size for the training set: Not applicable (no "training set" for a physical device).
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes the mechanical performance testing of a physical medical device (spinal fixation system) against engineering standards, not the validation of an AI-powered device or a clinical study that would involve expert readers, patient data, and human-in-the-loop performance. Therefore, I cannot extract the requested information from this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 13, 2018

Premia Spine Ltd. % Janice Hogan, J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K182598

Trade/Device Name: VersaLink™ Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: November 9, 2018 Received: November 9, 2018

Dear Ms. Hogan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 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.

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K182598

Device Name VersaLink™ Fixation System

Indications for Use (Describe)

The VersaLink™ Fixation System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 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."

{3}------------------------------------------------

K182598 510(k) SUMMARY Premia Spine's VersaLink™ Fixation System

Premia Spine Ltd. 7 Giborey Israel Street Ramat Poleg, 4250407, Israel

Phone: 972-72-2281200 Facsimile: 972-72-2281201 Contact Person: Mr. Ron Sacher

Date Prepared: November 6, 2018

VersaLink™ Fixation System

21 C.F.R. 888.3070 Pedicle screw spinal system, Class II. Product codes: NKB - orthosis, spinal pedicle fixation, for degenerative disc disease

Primary Predicate

ProMIS™ Fixation System by Premia Spine Ltd. (K150380)

Intended Use / Indications for Use

The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

Device Description

The VersaLink™ System consists of 6 Ti-6AI-4V main parts:

1. The VersaLink rod (the Rod); a spinal fixation rod with a dedicated ring end designed to enable robust attachment to the pedicle screw head above the crossbar.
1. Ring nut: dedicated nut designed to be tightened on the Ring Set Screw and firmly fix the VersaLinkTM Rod on the pedicle screw head.
1. VersaLink Ring Set Screw Torx: dedicated setscrews with double thread designed to allow attachment of the VersaLink™ Rod device to the head of the pedicle screw above the crossbar.
1. Crossbar rod: a bent rod designed to fit the average angle of the lumbar vertebra pedicles. It is horizontally attached to two pedicle screws on the same vertebra in order to reduce peak loads by better distributing the loads between the pedicle screws.
1. Polyaxial Pedicle screws
1. Torx Setscrew.

{4}------------------------------------------------

Performance Data

The VersaLink™ Fixation System was subjected to static compression, static torsion, and dynamic compression testing per ASTM F1717. All devices functioned and met their acceptance criteria.

Substantial Equivalence

The VersaLink™ Fixation System and ProMS Fixation System have the same intended use and indication for same users' population.

The subject and predicate systems are made from the same materials and are composed of the same components, including pedicle screws, fusion rods, and set screws, and are operated according to the same principals.

The subject and predicate systems have similar components, made of same materials. Both systems are based on the same pedicle screws and set screws, with identical design, diameter and length. Both systems have fusion rods with similar diameter and length. The subject and predicate systems carry similar accessories and surgical instrumentation set.

Conclusions

The subject VersaLink™ Fixation System is substantially equivalent to the cleared ProMS™ Fixation System. The subject system has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences raise no new issues of safety or effectiveness. Performance data demonstrate that the VersaLink™ Fixation System is substantially equivalent to its predicate.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.