The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Device Description

The BALTEUM - ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an antero-lateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.

AI/ML Overview

This document is a 510(k) summary for the BALTEUM - ONE™ Lumbar Plate System. It describes the device, its intended use, and the studies performed to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical study report for evaluating performance in terms of diagnostic accuracy or similar metrics.

It focuses on non-clinical (mechanical) testing to demonstrate substantial equivalence for a medical implant device, not a diagnostic AI device. Therefore, many of the requested categories are not applicable to the information provided.

Here's an breakdown of the available information based on your request:

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

The document does not specify "acceptance criteria" in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. for a AI device. Instead, it states that "Non-clinical testing was performed to demonstrate that the subject BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the predicate device."

The reported performance is that the device "demonstrates that the BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the legally marketed predicate devices" based on the following tests conducted in accordance with ASTM F1717:

Static compression
Dynamic compression
Static Torsion

A detailed table of acceptance criteria and specific numerical results for these mechanical tests is not provided in this summary. It only states that the device was found substantially equivalent based on these tests.

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

This information is not applicable and not provided. The testing described is non-clinical (mechanical) on the device itself, not on patient data.

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 information is not applicable and not provided, as the study is not related to diagnostic accuracy or interpretation by experts.

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

This information is not applicable and not provided.

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 information is not applicable and not provided. This is a mechanical device, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided.

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

For mechanical testing, the "ground truth" would be established by the physical properties and performance characteristics of the predicate devices under standardized testing conditions (ASTM F1717).

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI/machine learning study.

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

This information is not applicable and not provided, as this is not an AI/machine learning study.

In summary: This document is a regulatory submission for a physical medical device (spinal implant), not a diagnostic device or an AI product. Therefore, the details requested about acceptance criteria, study design for diagnostic accuracy, expert involvement, and ground truth for AI models are not present. The studies performed were non-clinical mechanical tests to demonstrate that the new device is "substantially equivalent" in its physical performance to already-approved predicate devices.

Summary

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March 25, 2022

Huvexel Co., Ltd % Milan George Vice President, R&D Dio Medical Corporation 2100 Campus Lane, Suite 100 East Norriton, Pennsylvania 19403

Re: K213820

Trade/Device Name: BALTEUM – ONE™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: December 23, 2021 Received: December 27, 2021

Dear Milan George:

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

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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-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 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) K213820

Device Name BALTEUM - ONE™ Lumbar Plate System

Indications for Use (Describe)

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

HUVEXEL Co., Ltd's BALTEUM - ONE™ Lumbar Plate System

Sponsor:
Manufacturer	HUVEXEL Co., Ltd.101-105 Megacenter, SKn Technopark124 Sagimakgol-ro, Jungwon-guSeongnam-siGyeonggi-do, South Korea
Official ContactPhone:	Milan George877-394-5407x102
Date:	December 7, 2021
Device Name:	BALTEUM - ONE™ Lumbar Plate System
Common Name:	Anterior Thoracolumbosacral Plate
ClassificationName:	Spinal intervertebral body fixation orthosis, 21 CFR 888.3060
ClassificationNumber:	Class II
ProductCode/Classification:	KWQ
Description:	The BALTEUM - ONE™ Lumbar Plate System consists of non-sterile,single use, rigid plates and bone screws of varying sizes and lengthsto fit the anatomical needs of a wide variety of patients. The plateattaches by means of screws to the vertebral body of thethoracolumbar spine (T1-L5) either through an antero-lateral, orlateral approach and to the lumbar/lumbosacral spine (L1-S1)through an anterior approach. The system includes instrumentationwhich assists in the surgical implantation of the device.
Intended Use:	The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate Systems areintended for use via a lateral or anterolateral surgical approachabove the bifurcation of the great vessels in the treatment ofthoracic and thoracolumbar (T1-L5) spine instability or via theanterior surgical approach, below the bifurcation of the great vesselsin the treatment of lumbar and lumbosacral (L1-S1) spine instabilityas a result of fracture (including dislocation and subluxation), tumor,degenerative disc disease (defined as back pain of discogenic origin

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	with degeneration of the disc confirmed by patient history andradiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, ora failed previous spine surgery. The device is intended as atemporary fixation device until fusion is achieved.
Performance Data:	Non-clinical testing was performed to demonstrate that thesubject BALTEUM - ONE™ Lumbar Plate System is substantiallyequivalent to the predicate device. The following testing wasperformed in accordance with the ASTM F1717:- Static compression- Dynamic compression- Static TorsionThe nonclinical tests demonstrate that the BALTEUM - ONE™Lumbar Plate System is substantially equivalent to the legallymarketed predicate devices.
Predicate Device:	Primary predicate: BALTEUM™ Lumbar Plate System (K200846) -HUVEXEL Co., LtdAdditional predicates: Globus Medical – Plymouth™ ThoracolumbarPlate System (K120092), Globus Medical – TRUSST™ ThoracolumbarPlate System (K092108), NuVasive Lateral Plate System (K091071)and Globus Medical - REVERE™ Stabilization System (K061202)
TechnologicalCharacteristics	The BALTEUM - ONE™ Lumbar Plate System was shown to besubstantially equivalent and has equivalent technologicalcharacteristics to its predicate and reference devices throughcomparison in areas including design, labeling/intended use,material composition, function, range of sizes, and packaging.
Performance andSE Determination:	The BALTEUM - ONE™ Lumbar Plate System have beendemonstrated to be substantially equivalent to the predicatesystem(s) with respect to technical characteristics, performance,and intended use. The information provided within this premarketnotification supports substantial equivalence of the subject deviceto the predicate device(s).

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.