The icotec Anterior Cervical Plate 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 cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

Device Description

The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded. The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the icotec Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving that the device meets specific performance criteria for an AI/ML product. Therefore, the requested information regarding acceptance criteria for AI/ML device performance, ground truth establishment, training sets, and MRMC studies is not present in this document.

The document details the device's indications for use, its description, and the predicate devices used for comparison. It also lists performance testing that was conducted, which primarily involves mechanical biocompatibility and structural integrity tests relevant to a spinal implant, not an AI/ML algorithm.

Here's a breakdown of the information that is available, and why the requested AI/ML specific information is absent:

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

Acceptance Criteria (Mechanical/Biocompatibility): The document states that "The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria." However, the specific numerical acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not provided in this summary.
Reported Device Performance (Mechanical/Biocompatibility): Similarly, the actual numerical results of these tests are not reported in this summary, only the qualitative statement that they "met the pre-defined acceptance criteria."

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

Not Applicable for this type of device: This information typically pertains to clinical studies for AI/ML devices or drugs. For this mechanical implant, "sample size" would refer to the number of devices tested for mechanical properties, which is not detailed in this summary. There is no "data provenance" in the sense of patient data for an AI/ML algorithm.

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: Ground truth establishment by experts is a concept for AI/ML model validation, not for the mechanical testing of a spinal plate.

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

Not Applicable: Adjudication methods are used in clinical trials or AI/ML evaluations to resolve disagreements among readers/experts. This is not relevant to mechanical testing.

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: MRMC studies are used to evaluate diagnostic performance, especially for AI/ML algorithms assisting human readers. This device is a mechanical implant, not a diagnostic AI/ML tool.

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

Not Applicable: This refers to the performance of an AI/ML algorithm in isolation. This device is a physical implant.

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

Not Applicable (for AI/ML context): For mechanical testing, the "ground truth" would be engineering specifications and ASTM standards.

8. The sample size for the training set

Not Applicable: There is no AI/ML model being trained for this device.

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

Not Applicable: There is no AI/ML model being trained for this device.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) demonstrating substantial equivalence based on mechanical and biocompatibility testing, not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML specific acceptance criteria, study methodologies, and ground truth establishment are not addressed in this document.

Summary

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October 15, 2020

icotec ag % Margeaux Rogers Associate Director, Regulatory Affairs MCRA, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K201587

Trade/Device Name: icotec Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: September 18, 2020 Received: September 18, 2020

Dear Margeaux Rogers:

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-reporting-

combination-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 medical devices and radiation-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) K201587

Device Name icotec Anterior Cervical Plate System

Indications for Use (Describe)

The icotec Anterior Cervical Plate System is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

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

Device Trade Name:	icotec Anterior Cervical Plate System
Manufacturer:	icotec agIndustriestrasse 129450 AltstättenSwitzerlandwww.icotec-medical.comPhone: +41 71 757.0000
Contact:	Ms. Marina HessCQO/Management Representativeicotec ag
Prepared by:	Ms. Margeaux RogersAssociate Director, Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001mrogers@mcra.com
Date Prepared:	September 18th, 2020
Classifications:	21 CFR §888.3060, Spinal intervertebral body fixation orthosis
Class:	II
Product Codes:	KWQ

Indications for Use:

Device Description:

The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21

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up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded.

The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

Primary Predicate Devices:

The icotec Anterior Cervical Plate System is substantially equivalent in device indications, design, and performance to the following primary predicate device.

Aesculap, Inc. (AIS) ABC2 Cervical Plating System (K050813) ●

Additional Predicate Devices:

The following additional predicate devices are presented to further demonstrate substantial equivalence since these devices contribute incremental benefit to the substantial equivalence profile with the device indications, design, mechanical performance, and clinical performance:

EBI VueLock™ Anterior Cervical Plate System (K023133)
Synthes Spine Anterior CSLP System (K030866) ●

The following reference device is substantially equivalent to the subject device with respect to materials and manufacturing technology and methods:

VADER®one Pedicle System MIS and Lightmore® Pedicle System 6.0 (K190545, ● K193423)

Performance Testing Summary:

The testing of the icotec Anterior Cervical Plate System includes:

Static compression bending, static torsion and dynamic compression bending per ASTM F1717
-Biocompatibility Assessment
Clinical Data -

Substantial Equivalence:

The subject devices were demonstrated to be substantially equivalent to predicates cited above with respect to indications, design, materials, function, manufacturing, and performance. The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria. The results of the performed tests demonstrate that the icotec Anterior Cervical Plate System is substantially equivalent to the legally marketed predicate devices.

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Conclusion:

The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the icotec Anterior Cervical Plate System to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.