The 4CIS® Chiron Spinal Fixation System is 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:

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis
Trauma (i.e., fracture or dislocation)
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Stenosis
Failed previous fusion (pseudoarthrosis).

Device Description

The 4CIS® Chiron Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, instruments are available for the application and removal of the Spinal Fixation System.

AI/ML Overview

This document is a 510(k) premarket notification for the "4CIS® Chiron Spinal Fixation System." It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data. However, it does not include detailed acceptance criteria or extensive study results that would typically be found in a clinical trial report.

Here's an analysis of the provided text in relation to your questions:

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

The document provides summary statements about performance data but does not explicitly list acceptance criteria or specific numerical results in a table format. It states:

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent to predicate device performance under similar test conditions	"Mechanical testing confirmed the 4CIS® Chiron Spinal Fixation System demonstrated equivalent performance to the cited predicate device under the same test conditions."

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

The document mentions "Mechanical testing was performed," but does not explicitly state the sample size (e.g., number of spinal fixation systems tested) for this testing. It also doesn't specify the country of origin for the data or whether it was retrospective or prospective. Given it's mechanical testing of a physical device, it's typically performed in a lab setting rather than involving human subjects or real-world data in the same way clinical studies do.

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)

This question is not applicable to the type of data presented. The "ground truth" for mechanical testing is based on the physical properties and performance of the device under defined conditions, typically measured by engineering standards and equipment, not by expert medical interpretation.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for diagnoses or interpretations. Mechanical testing uses objective measurements against predefined standards.

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

No such study was mentioned or performed. This document is for a spinal fixation system, which is a physical implant, not an AI software or a device that assists human readers/diagnosticians.

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

This question is not applicable, as this is a physical medical device, not a software algorithm.

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

The ground truth for the performance of the 4CIS® Chiron Spinal Fixation System, as described, is based on mechanical testing results against established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the performance of predicate devices. This is an engineering-based ground truth.

8. The sample size for the training set

This question is not applicable. The device is a physical implant. The concept of a "training set" is relevant for machine learning models, not for mechanical testing of a spinal fixation system.

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

This question is not applicable, as there is no training set for this type of device and testing.

Summary

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November 26, 2024

Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Solco Biomedical Co., Ltd. Seo-Hee Koo RA & Exam Certification Team Researcher 154 Seotan-ro, Seotan-myeon Pyeongtaek-Si. 17704 South Korea

Re: K231655

Trade/Device Name: 4CIS® Chiron Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: October 28, 2024 Received: October 28, 2024

Dear Seo-Hee Koo:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely, Digitally signed Eileen by Eileen Cadel -S
Date: Cadel -2024.11.26 S 13:56:02 -05'00' 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) K231655

Device Name

4CIS® Chiron Spinal Fixation System

Indications for Use (Describe)

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis

1. Trauma (i.e., fracture or dislocation)
1. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

Tumor
Stenosis

1. Failed previous fusion (pseudoarthrosis)
  Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. 510(k) Summary

Submitter	Solco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,17704 Republic of KoreaPhone. +82-31-664-4101Fax. +82-31-663-8983
Contact Person	Seo-Hee KooSolco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,17704 Republic of KoreaPhone: +82)31-610-4079Fax: +82)31-663-8983
Submission Date	May 25, 2023
Trade / Proprietaryname	4CIS® Chiron Spinal Fixation System
Common / UsualName	Spinal Fixation System
Classification NameClassification CodeRegulatory ClassRegulation Number	Thoracolumbosacral pedicle screw systemNKB, KWPClass II888.3070
	4CIS® Chiron Spinal Fixation System (K203233)[Solco
Predicate Device	Biomedical Co., Ltd.] – Primary Predicate
	EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2SYSTEM (K111136) [DEPUY SPINE, INC.] – AdditionalPredicate
	MOSS MIAMI SPINAL SYSTEM (K030383) [DEPUYAcroMed Inc.] – Additional Predicate
	SYNERGY™ TI INTEGRAL OPEN SCREW SYSTEM(K012871) [Interpore Cross International, LLC] –Additional Predicate
	LDR Spine Easyspine Posterior Spinal System (K123134)[LDR Spine USA] – Additional Predicate
Description of Device	The 4CIS® Chiron Spinal Fixation System is a top-loadingposterior spinal fixation system which consists of pediclescrews, rods, nuts, transverse (cross) link and associatedinstruments. Rigid fixation is provided by pedicle screwsinserted into the vertebral body through pedicle of thelumbar spine via posterior approach. This system will allowsurgeons to build a spinal implant construct to stabilize andpromote spinal fusion through open surgery or minimallyinvasive surgery. Implant components can be rigidly lockedinto a variety of different configurations to suit theindividual pathology and anatomical conditions of themature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy(Ti-6A1-4V ELI) that conforms to ASTM F 136 and CobaltAlloy (Co-28Cr-6Mo) per ASTM F1537. Also, instrumentsare available for the application and removal of the SpinalFixation System.
Indication for Use	The 4CIS® Chiron spinal fixation system is intended toprovide immobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in thetreatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar and sacral spine:1. Degenerative disc disease (defined as discogenic back painwith degeneration of the disc confirmed by history andradiographic studies);2. Spondylolisthesis;
	3. Trauma (i.e., fracture or dislocation);
	4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/orlordosis);
	5. Tumor;
	6. Stenosis;
	7. Failed previous fusion (pseudoarthrosis).
Comparison ofTechnologicalCharacteristics withthe Predicate Devices	The 4CIS® Chiron Spinal Fixation System and all thepredicates have the same or similar indications for usestatements. The system is composed of the same material as thepredicate devices conforming to recognized industry standardsfor permanent implants and surgical orthopedic instruments.The 4CIS® Chiron Spinal Fixation System and cited predicatedevices share similar basic design features and functions aswell as their dimensions. Also they are provided non-sterile forsingle use only. Mechanical testing confirmed the 4CIS®Chiron Spinal Fixation System demonstrated equivalentperformance to the cited predicate device under the same testconditions.
Performance Data	Mechanical testing was performed including static and dynamiccompression bending and static torsion testing per ASTMF1717 as well as axial and torsional grip testing and tulip-dissociation testing per ASTM F1798.
Conclusion	The overall technology characteristics and mechanicalperformance data lead to the conclusion that the subject deviceis substantially equivalent to legally marketed predicatedevices.

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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.