When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® one pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 6.0 are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

Device Description

The purpose if this Traditional 510(k) is to seek marketing clearance for the G21 Cement (V-Steady and V-Fast Bone Cements) to be used with the VADER® Pedicle System and to seek clearance for the VADER® Pedicle System.

V-Steady and V-Fast are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty or kyphoplasty. Bone cements are self-curing systems consisting of liquid and powder components:

The powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.

The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-Steady bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-Fast has a low initial viscosity and a long working time allowing to work extremely carefully especially when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile. The sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.

The sterilization process is ethylene oxide and it has been properly validated. Preparation and application procedures of the subject devices are detailed within the labeling as Mixing Phase, Waiting Phase, Application Phase, Setting/Hardening Phase.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA, which outlines the substantial equivalence of medical devices (G21 Cement and VADER® Pedicle System) to already legally marketed devices. It primarily focuses on the device's intended use, description, and performance testing summaries for mechanical and material properties, rather than AI/algorithm-based diagnostic or prognostic performance.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" related to AI/algorithm performance (e.g., sample size for test set, expert consensus for ground truth, MRMC studies, standalone algorithm performance) is not applicable to this document.

The acceptance criteria and performance studies detailed in this 510(k) summary are for the physical and mechanical properties of the bone cement and pedicle screw system.

Here's a breakdown of the relevant information from the document that loosely relates to your request, but is specific to the mechanical device, not an AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "table" for acceptance criteria as one would expect for an AI algorithm. Instead, it lists the types of performance testing conducted, implying that the acceptance criteria are adherence to the specific ASTM standards and demonstration of substantial equivalence to predicate devices. The reported performance is that the devices met these standards and were found substantially equivalent.

Test Type	Acceptance Criteria (Implied)	Reported Performance
ASTM F543 Screw Testing	Adherence to specific strength/mechanical properties for screws	Results demonstrate substantial equivalence to legally marketed predicate devices.
ASTM F1717 Pedicle Screw System Testing	Adherence to specific strength/mechanical properties for the pedicle screw system	Results demonstrate substantial equivalence to legally marketed predicate devices.
ASTM F1798 Flexion Bending and Torsional Gripping	Adherence to specific resistance to bending/torsion	Results demonstrate substantial equivalence to legally marketed predicate devices.
ASTM F1877 Particle Analysis of Post-Fatigue Samples	Acceptable particle analysis post-fatigue (e.g., wear debris)	Results demonstrate substantial equivalence to legally marketed predicate devices.
G-21 Cement injection properties with icotec fenestrated screws	Acceptable injection characteristics and compatibility	Tested and found satisfactory for intended use.
Biocompatibility Assessment	Meeting biocompatibility standards for implanted materials	Assessed and found compliant.
Clinical Data	(Likely refers to existing clinical use, or limited clinical data if applicable to the predicate, as this is a 510(k))	Included in the submission. specific details not provided.

Note: The document states "The results of the performed tests demonstrate that the VADER® Pedicle System is substantially equivalent to legally marketed predicate devices." This is the reported performance against the implied acceptance criteria of meeting or exceeding the predicate device's performance based on these standards.

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

Sample Size: Not explicitly stated for each test. For mechanical testing (ASTM standards), the sample size would typically be a specific number of devices/implants per test as required by the standard. This is not "data" in the sense of patient data.
Data Provenance: Not applicable in the context of patient data. The "data" comes from in vitro mechanical and material testing conducted by the manufacturer (icotec ag) in Switzerland. The "clinical data" mentioned is not detailed, but for a 510(k), it often refers to references to existing literature or limited clinical use data, not necessarily new prospective studies for the 510(k) itself unless specified.

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

Not applicable. Ground truth as typically understood for AI-based diagnostic/prognostic devices (e.g., radiological interpretation) is not relevant here. The "ground truth" for these tests comes from objective physical measurements and adherence to engineering standards.

4. Adjudication method for the test set:

Not applicable. This is not a human interpretation task.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not applicable. This is for mechanical device performance, not AI assistance for human readers.

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

Not applicable. This is a PMMA bone cement and pedicle screw system, not an algorithm.

7. The type of ground truth used:

For mechanical tests: Objective physical measurements against established ASTM standard specifications.
For biocompatibility: Adherence to relevant biocompatibility standards.
For "Clinical Data": Details are not provided, but it likely refers to existing literature/clinical experience with similar devices or limited clinical data demonstrating safety and performance.

8. The sample size for the training set:

Not applicable. This document is not about an AI/ML algorithm.

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

Not applicable. This document is not about an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance for a mechanical medical device (bone cement and pedicle screws). The "acceptance criteria" and "proof" relate to standard engineering, material, and biocompatibility testing, demonstrating substantial equivalence to predicate devices, rather than the performance metrics and study designs typically associated with AI/ML-based medical devices.

Summary

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October 13, 2020

Icotec AG % Justin Eggleton Vice President, Spine Regulatory Affairs Musculosketal Clinical Regulatory Affairs 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K200596

Trade/Device Name: G21 Cement, VADER® Pedicle System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: PML, NKB Dated: August 27, 2020 Received: August 27, 2020

Dear Justin 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. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200596

Device Name G21 Cement

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Indications for Use

510(k) Number (if known) K200596

Device Name VADER® Pedicle System

Indications for Use (Describe)

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

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)

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.

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."

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510(k) Summary

Device Trade Name:	G21 CementVADER® Pedicle System
Manufacturer:	icotec agIndustriestrasse 129450 AltstättenSwitzerlandwww.icotec-medical.comPhone: +41 71 757.0000
Contact:	Ms. Marina HessCQO/Management Representativeicotec ag
Prepared by:	Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001jeggleton@mcra.com
Date Prepared:	October 9, 2020
Classifications:	G21 Cement:21 CFR §888.3027, Polymethylmethacrylate (PMMA) BoneCementVADER® Pedicle System:21 CFR §888.3070, Thoracolumbosacral Pedicle ScrewSystem
Class:	II
Product Codes:	PML, NKB
Indications for Use:

G21 Cement:

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VADER® Pedicle System

The VADER® Pedicle System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

Device Description:

The powder component is constituted of PMMA beads shaped particles ● containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.

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K200596 Page 3 of 3

Primary Predicate Devices:

Steady and V-Fast (K150408)

Additional Predicate Devices:

icotec VADER®one Pedicle System MIS and LightMore® Pedicle System6.0 ● (K190545)
icotec Pedicle System (K151977) ●
Blackstone Pedicle Screw System (K082797)
Corelink Tiger Spine System (K113058)
CarboFix Pedicle Screw System (K182377)
CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement (K190526)

Performance Testing Summary:

The testing of the VADER® Pedicle System includes:

ASTM F543 Screw Testing ●
ASTM F1717 Pedicle Screw System Testing ●
ASTM F1798 Flexion Bending and Torsional Gripping ●
ASTM F1877 Particle Analysis of Post-Fatigue Samples ●
G-21 Cement injection properties with icotec fenestrated screws
Biocompatibility Assessment ●
Clinical Data ●

Substantial Equivalence:

The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance. The non-clinical tests performed by the company include static and dynamic compression per ASTM F1717 and screw testing per ASTM F543 and ASTM F1798. The results of the performed tests demonstrate that the VADER® Pedicle System is substantially equivalent to legally marketed predicate devices.

Conclusion:

The purpose of the traditional 510(k) is to receive regulatory clearance for the G21 Cement (V-Steady and V-Fast Bone Cements) to be used with the VADER® Pedicle System and to seek clearance for the VADER® Pedicle System and to introduce the VADER® Pedicle System to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate device.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”