The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:

Degenerative disc disease (DDD) (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis and tumors, deformity (e.g., scoliosis, kyphosis, lordosis), pseudoarthrosis, failed previous fusions.

Device Description

The CarboClear Cervical Plate System comprises implants (plates and screws) in different dimensions, and instruments.

The CarboClear cervical plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and may incorporate tantalum markers. The screws are made of titanium alloy.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically the CarboClear® Cervical Plate System. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, the provided document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML powered diagnostic or prognostic device.

The document discusses the following:

Device Name: CarboClear® Cervical Plate System
Intended Use: Anterior fixation of the cervical spine for temporary stabilization during fusion development in patients with various spinal conditions.
Materials: Carbon fiber reinforced PEEK for plates, titanium alloy for screws.
Predicate Devices: Several predicate devices are listed, including Spider® Cervical Plating System and Anterior CSLP System.
Substantial Equivalence: The submission claims substantial equivalence based on intended use, design, materials, technological characteristics, principles of operation, and mechanical performance.
Performance Testing: Static and dynamic compression bending, static torsion (per ASTM F1717), and static screw pushout testing were conducted, and the results were found to be comparable to predicate devices. Bacterial endotoxin evaluation was also performed.

To answer your specific questions, based only on the provided text, I must state that the requested information is not present:

A table of acceptance criteria and the reported device performance: Not provided. The document states "Performance characteristics... are comparable to those of predicate devices," but no specific acceptance criteria or quantitative performance data are given.
Sample size used for the test set and the data provenance: Not applicable or provided. This is physical device testing, not a data-driven AI/ML study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would likely refer to engineering specifications and measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
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. This is not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not directly specified in terms of "ground truth" for a diagnostic study. Mechanical performance is compared against predicate devices and ASTM standards.
The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.

Summary

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June 4, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CarboFix Orthopedics, Ltd. Ms. Yael Rubin Director of Regulatory Affairs 11 Ha'Hoshlim St. Herzeliya, 4672411 Israel

Re: K200883

Trade/Device Name: CarboClear® Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 30, 2020 Received: April 2, 2020

Dear Ms. Rubin:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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. Acting 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) K200883

Device Name CarboClear® Cervical Plate System

Indications for Use (Describe)

CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine.

The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary

CarboFix Orthopedics Ltd.

CarboClear® Cervical Plate System

Applicant Name

CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel

Contact Person

Yael Rubin CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939

Date Prepared

March 2020

Trade/Proprietary Name

CarboClear® Cervical Plate System

Common Name Appliance, Fixation, Spinal Intervertebral Body

Classification Name

Spinal intervertebral body fixation orthosis (21 CFR §888.3060; Class II; Product Code KWQ).

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Predicate Devices

Primary

. Spider® Cervical Plating System (X-spine Systems, Inc.; K170224, and more) Additional

Anterior CSLP System (Synthes; K030866, and more) '
. Reflex® Hybrid Anterior Cervical Plate System (Stryker; K040261, and more)

Reference

. CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377)
Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, I K130061, K182015, and more)

Indications for Use

CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine.

The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:

System Description

The CarboClear Cervical Plate System comprises implants (plates and screws) in different dimensions, and instruments.

The CarboClear cervical plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and may incorporate tantalum markers. The screws are made of titanium alloy.

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Substantial Equivalence

The CarboClear Cervical Plate System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.

Performance characteristics, including static and dynamic compression bending, and static torsion, per ASTM F1717, and static screw pushout testing, are comparable to those of predicate devices (as applicable), thus demonstrating substantially equivalent mechanical performance of the subject device.

In addition, bacterial endotoxin evaluation was conducted for the system.

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.