The CarboClear® X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.

The CarboClear® X Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Device Description

The CarboClear® X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.

The implants include pedicle screws, rods, and a locking element (set screw). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants may include tantalum markers. Titanium alloy rod is also available.

The implants are supplied sterile, and are intended for single use.

The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the CarboClear® X Pedicle Screw System. This document is a regulatory submission for a medical device, specifically spinal implants. It focuses on demonstrating that the new device is substantially equivalent to existing predicate devices already on the market.

Crucially, this document does not describe studies proving device meets acceptance criteria related to AI/software performance or diagnostic accuracy. It primarily discusses the mechanical performance and material equivalence of a physical implant system (pedicle screws) to predicate devices, and an expansion of its indications for use.

Therefore, many of the requested items related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained within this regulatory submission.

However, I can extract information relevant to the device's performance as understood in the context of this specific regulatory submission for a physical medical device:

Acceptance Criteria and Device Performance (Mechanical/Physical)

For this type of medical device (pedicle screws), "acceptance criteria" and "performance" relate to mechanical and material characteristics rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test Standard	Performance/Result	Notes
Mechanical Stability	ASTM F1717	Results comparable to predicate devices.	Includes static and dynamic tests for spinal implant constructs.
Axial Gripping Capacity	ASTM F1798	Results comparable to predicate devices.	Relates to the ability of the screws to grip the bone.
Torsional Gripping Capacity	ASTM F1798	Results comparable to predicate devices.	Relates to the rotational stability of the screws in the bone.
Static Flexion-Extension	ASTM F1798	Results comparable to predicate devices.	Simulates spinal movement.
Material Equivalence	Not explicit standard, but inferred	Components (pedicle screws, rods, locking elements) made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). Threaded portion of screws encased in thin titanium shell. Tantalum markers may be included. Titanium alloy rod also available.	Compared to predicate devices, especially the primary predicate, the subject device's implant components are "the same."
Geometric Equivalence	Not explicit standard, but inferred	Subject device includes "longer rods" compared to primary predicate. Otherwise, implant components are "the same."	This is the basis for the "expansion of indications for use."

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

The document mentions "Performance Data" from mechanical tests (ASTM F1717, ASTM F1798). It does not specify the sample size for these tests (e.g., number of constructs tested, number of screws).
The data provenance is not explicitly stated beyond being part of this 510(k) submission by CarboFix Orthopedics Ltd. (Israel-based company). It's scientific laboratory data gathered for regulatory purposes, typically conducted in a controlled lab environment. It is prospective testing for the submission, not retrospective data.

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

This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM standards) and the physical measurements obtained from those tests, not by expert human interpretation.

4. Adjudication method for the test set:

Not applicable for 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 as this is not an AI/software device.

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

Not applicable as this is not an AI/software device.

7. The type of ground truth used:

The "ground truth" for this device's performance relies on objective physical measurements derived from standardized mechanical testing (e.g., load-displacement curves, fatigue life) compared against established performance benchmarks within the specific ASTM standards for spinal implants and demonstrating comparability to predicate devices.

8. The sample size for the training set:

Not applicable as this is not an AI/software device.

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

Not applicable as this is not an AI/software device.

Summary regarding the provided document:

The provided document (a 510(k) clearance letter and summary) is for a physical medical device (pedicle screw system), not an AI/software device. As such, the "acceptance criteria" and "performance studies" described are entirely focused on the mechanical and material properties of the implant, demonstrating its substantial equivalence to already cleared devices. The detailed questions about AI, ground truth, experts, and MRMC studies are not relevant to the content of this specific regulatory submission.

Summary

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August 1, 2024

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. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'Hoshlim Street Herzeliya, 4672411 Israel

Re: K233793

Trade/Device Name: CarboClear® X Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 2, 2024 Received: June 3, 2024

Dear Hila Wachsler-Avrahami:

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 QS 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 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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is from Eileen Cadel. The date of the signature is August 1st, 2024. The time of the signature is 08:59:46 -04'00'.

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

Submission Number (if known)

K233793

Device Name

CarboClear® X Pedicle Screw System

Indications for Use (Describe)

CarboClear® X Pedicle Screw System (DDD)

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

CarboFix Orthopedics Ltd.

CarboClear® X Pedicle Screw System

Applicant Name

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

Contact Person

Hila Wachsler-Avrahami CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939

Date Prepared

June 2, 2024

Trade/Proprietary Name

CarboClear® X Pedicle Screw System

Common Name

Pedicle Screw System

Regulation Number and Device Class

Class II; 21 CFR §888.3070

Product Code, Regulatory Description and Review Panel

NKB; Thoracolumbosacral Pedicle Screw System; Orthopedic

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Predicate Devices

Primary Predicate Device:

CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K233944, K240846)

Additional Predicate Devices:

" CarboClear® Pedicle Screw System (CarboFix Orthopedics Ltd.; K232341)
CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716, K231280)
· CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more)
· S4® Spinal System (Aesculap Spine; K130291 and more)

Intended Use/Indications for Use

CarboClear® X Pedicle Screw System

System Description

The implants are supplied sterile, and are intended for single use.

The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

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Purpose of Submission

Expansion of indications for use.

Comparison of Technological Characteristics with Predicate Devices

Compared to the primary predicate device, the subject CarboClear® X System includes longer rods. Otherwise, the subject CarboClear® X implant components are the same as the corresponding implant components of the cleared CarboClear X Pedicle Screw System (K233944, K240846).

Performance Data

Performance characteristics of the CarboClear® X Pedicle Screw System included static and dynamic tests according to ASTM F1717, as well as static flexion-extension test, axial gripping capacity test, and torsional gripping capacity test according to ASTM F1798. The results of the tests are comparable to those of the predicate devices, demonstrating substantially equivalent performance of the subject and predicate devices.

Substantial Equivalence

The intended use, design, dimensions, materials, technological characteristics, principles of operation, and performance of the subject CarboClear® X Pedicle Screw System are substantially equivalent to those of the predicate devices.

Conclusion

Based on the information provided in this 510(k) Premarket Notification, the subject CarboClear® X Pedicle Screw System is substantially equivalent to its predicate devices.

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.