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.

When used with the icotec Cervical Cage or the KONG®-C VBR System, the icotec Anterior Cervical Plate System is intended to stabilize the cervical (from C2 to T1) spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

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 devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate tantalum markers per ASTM F560.

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 18 mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94 mm. The plates are precontoured to fit patient anatomy. The screw holes in the plates are conical and threaded.

The icotec Anterior Cervical Plate System self-tapping screws are available in diameters of 4.0 and 4.25 mm with lengths of 13 and 15 mm. 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 describes the regulatory clearance (K233215) for the icotec Anterior Cervical Plate System. The information provided focuses on the device's technical specifications and the basis for its substantial equivalence to a predicate device, rather than detailed performance study results against specific, quantifiable acceptance criteria.

The provided text does not contain a detailed study with specific acceptance criteria and reported device performance in the format of a table as requested. Instead, it presents a summary of non-clinical and clinical data supporting substantial equivalence.

Based on the provided text, here's an attempt to extract and infer the requested information, noting limitations due to the nature of the available document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter for a 510(k) submission typically does not present performance data in a detailed table against pre-defined acceptance criteria, especially for a device seeking substantial equivalence based on prior clinical data without a de novo clinical trial. Instead, it refers to a summary of performance testing and clinical data that broadly supported substantial equivalence.

Acceptance Criteria Category	Reported Device Performance as per Document
Non-clinical Performance	Non-clinical testing data demonstrate the performance of the subject device is substantially equivalent to that of the predicate device. The document mentions the device is manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporates tantalum markers per ASTM F560. Specific mechanical or material acceptance criteria and their results are not detailed in this summary.
Clinical Performance (Safety & Efficacy)	"The clinical data provided supports a substantially equivalent safety and effectiveness profile for the use of anterior cervical plate devices for the indications for use." The document explicitly states: "However, the provided clinical data did not support that the specific material or unique technological characteristics of the subject device components provides additional benefit relative to other anterior cervical plate devices for the indications for use related to infection." This suggests that while equivalence was shown, superiority or additional benefit for specific aspects (like infection) was not demonstrated.
Substantial Equivalence	The device was demonstrated to be substantially equivalent to the predicate device (K201587) with respect to indications for use, intended use, design, and performance, based on non-clinical testing data and clinical data. The subject and predicate devices are stated to have similar technological characteristics, be made of similar materials, and are packaged/sterilized by identical methods. The conclusion is that the device is substantially equivalent.

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

Sample Size for Test Set: Not specified in the provided text. The document refers to "clinical data provided" but does not detail the size or nature of this dataset in terms of individual patients or cases used for the "test set" (if a distinct test set was even explicitly defined in the context of this 510(k) submission).
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not available in the provided document. The clearance letter mentions "clinical data" but does not detail how ground truth was established for any specific test set, or the number and qualifications of experts involved in such a process.

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

This information is not available in the provided document.

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:

This document describes a spinal implant device (Anterior Cervical Plate System), not an AI/software device that would involve human readers or AI assistance in interpretation. Therefore, an MRMC study related to AI assistance would not be applicable in this context.

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

This document concerns a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

For a spinal implant device seeking 510(k) clearance based on substantial equivalence, the "ground truth" would typically refer to established clinical safety and effectiveness from the predicate device and the clinical data supporting the subject device's performance. This would involve "outcomes data" and potentially clinical assessments, but the specific methodology (e.g., expert consensus on outcomes) is not detailed here. The document states "clinical data provided supports a substantially equivalent safety and effectiveness profile."

8. The sample size for the training set:

This concept of "training set" is relevant for AI or machine learning models. This document is about a physical medical device. Therefore, a "training set" in that context is not applicable.

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

As above, the concept of a "training set" for ground truth establishment is not applicable to this type of device.

Summary

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May 17, 2024

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Icotec AG % Justin Eggleton VP, Head of Musculoskeletal Regulatory Affairs Mcra, LLC. 803 7th Street NW, 3rd floor Washington, District of Columbia 20001

Re: K233215

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: KWQ Dated: April 19, 2024 Received: April 19, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Colin O'neill -S 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

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Indications for Use

510(k) Number (if known) K233215

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:	Mr. Justin EggletonVice President, Head of Musculoskeletal Regulatory AffairsMCRA, LLC803 7th Street NWWashington, DC 20001Phone: 202.552.5804Email: jeggleton@mcra.com
Date Prepared:	May 15, 2024
Classifications:	21 CFR §888.3060, Spinal intervertebral body fixation orthosi
Class:	II
Product Codes:	KWQ
Primary Predicate:	icotec Anterior Cervical Plate System (K201587)
Reference Device:	icotec VADER® Pedicle System (K232628)

Indications For Use:

When used with the icotec Cervical Cage or the KONG®-C VBR System, the icotec Anterior Cervical Plate System is intended to stabilize the cervical (from C2 to T1) spine as an adjunct to

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fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

Device Description:

Predicate Device:

The icotec Anterior Cervical Plate System is substantially equivalent to the primary predicate device cited on the previous page with respect to indications, design, function, and performance.

Performance Testing Summary:

The clinical data provided supports a substantially equivalent safety and effectiveness profile for the use of anterior cervical plate devices for the indications for use. However, the provided clinical data did not support that the specific material or unique technological characteristics of the subject device components provides additional benefit relative to other anterior cervical plate devices for the indications for use related to infection.

Substantial Equivalence:

The subject device was demonstrated to be substantially equivalent to the predicate device (K201587) with respect to indications for use, intended use, design, and performance,

Non-clinical testing data and clinical data demonstrate the performance of the subject device is substantially equivalent to that of the predicate device, and support the performance of the subject device in its expanded indications for use.

Conclusion:

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in identical materials and are sterilized using identical methods. The data included

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in this submission demonstrate that the icotec Anterior Cervical Plate System is substantially equivalent to the predicate devices listed above.

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.