XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

Device Description

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is provided as a twocomponent system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.

AI/ML Overview

The provided text describes the 510(k) summary for a medical device, XeliteMed VertehighFix High Viscosity Spinal Bone Cement. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The acceptance criteria and study that proves the device meets those criteria are focused on non-clinical performance testing rather than clinical study data involving AI or human readers, as the device is a bone cement, not an AI-powered diagnostic tool. Therefore, many of the requested points regarding AI and human reader studies (MRMC, standalone AI, training set details) are not applicable to this type of device and submission.

Here's an interpretation of the text for the applicable criteria:

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

The document states that "Test data indicate that the final properties of XeliteMed VertehighFix High Viscosity Spinal Bone Cement are in compliance with the standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements' and are substantially equivalent to the predicate device."

While a specific table of numerical acceptance criteria and reported device performance values is not explicitly provided in this public summary, the general acceptance criterion is compliance with ISO 5833 and substantial equivalence to the predicate device (Mendec Spine K042415) for the following non-clinical tests:

Acceptance Criteria (General)	Reported Device Performance (General)
Compliance with ISO 5833 standards for bone cement	"in compliance with the standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements'"
Substantial Equivalence to Predicate Device (Mendec Spine K042415)	"substantially equivalent to the predicate device"
Met predefined limits for Bacterial Endotoxins Testing	"met the limits (<20 EU/device)"

The specific performance tests conducted were:

Setting time and Max temperature
Dough time
Intrusion
BPO content
Barium Sulfate Content
Trace elements
Residual monomer
Leachables
Molecular weights
NMR
Glass transition temperature
Powder morphology
Porosity, Dimension change
% Water Absorption
Stability
Compressive Strength & Compressive Modulus
Bending Strength & Bending Modulus
Tensile Strength & Tensile Modulus
Bacterial endotoxin testing (using USP <85> LAL test method)

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

The document does not specify the sample sizes (e.g., number of test specimens) used for each non-clinical test. The data provenance is from Xelite Biomed Ltd. in New Taipei City, Taiwan (R.O.C.), and the tests are inherently prospective as they are conducted on the newly manufactured device to demonstrate its properties.

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

This question is not applicable as the "ground truth" for bone cement performance is established by objective, standardized laboratory measurements according to ISO standards, not by expert consensus or interpretation of images.

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

This question is not applicable as there is no human interpretation or subjective adjudication involved in the objective non-clinical performance testing of bone cement.

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 question is not applicable as the device is a bone cement, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable as the device is a bone cement, not an AI algorithm.

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

The "ground truth" for this device's performance is based on established international standards (ISO 5833) and objective physical and chemical measurements of the bone cement's properties (e.g., mechanical strength, setting time, chemical composition, biocompatibility). For bacterial endotoxin testing, the ground truth is established by the USP <85> Bacterial Endotoxins Test limits.

8. The sample size for the training set

This question is not applicable as the performance testing described is for a physical medical device (bone cement), not a machine learning model that requires a training set.

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

This question is not applicable for the same reason as point 8.

Summary

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September 18, 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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

Xelite Biomed Ltd. Mandy Lin Regulatory Affairs Specialist 2F., No. 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist New Taipei City, 231022 Taiwan

Re: K241775

Trade/Device Name: XeliteMed VertehighFix High Viscosity Spinal Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: June 19, 2024 Received: June 20, 2024

Dear Mandy Lin:

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"

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(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).

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.

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-devices/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 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).

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Sincerely,

JESSE	Digitally signed byJESSE MUIR -S
MUIR -S	Date: 2024.09.1812:06:17 -04'00'

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma 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) K241775

Device Name

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Transaction Involving OFF-Highway Diesel	Transaction Involving OFF-Highway Kerosene
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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

1. Submission Information

Submitter:	XELITE BIOMED LTD.2F., No. 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist.,New Taipei City 231, Taiwan (R.O.C.) New Taipei City231022 Taiwan
Submitter contact:	Mr. Wei Chun ChangTel: +886-912111529E-mail: raychang@xelitemd.com
Prepared date:	2024-08-06

2. Device Name and Classification

Product Name:	XeliteMed VertehighFix High Viscosity SpinalBone Cement (HSA0125/HSA0200/HSA0250)
Classification Name:	Cement, Bone, Vertebroplasty
Common or Usual Name:	Polymethylmethacrylate (PMMA) bone cement
Regulation Number:	888.3027
Product Code:	NDN

3. Predicate Device(s)

Product Name:	Mendec Spine (K042415)
Common or Usual Name:	Polymethylmethacrylate (PMMA) bone cement
Regulation Number:	888.3027
Product Code:	NDN
Items	Predicate Device	Proposed Device
Device Name(Common name)	Mendec Spine(TECRES S.p.A)	XeliteMed VertehighFixHigh Viscosity SpinalBone Cement
K. number	K042415	/
Regulation Number	21 CFR 888.3027	Substantially identical
Product code	NDN	Substantially identical
Intended Use	Mendec Spine is indicated forthe treatment of pathologicalfractures of the vertebrae using avertebroplasty or kyphoplastyprocedure. Painful vertebralcompression fractures mayresult from osteoporosis, benignlesions (hemangioma), andmalignant lesions (metastaticcancers, myeloma).	Substantially identical
Main Components	Polymethylmethacrylate(PMMA)Methylmethacrylate (MMA)	Substantially identical
	Barium sulphate	Substantially identical
Other SignificantComponents	Benzoyl peroxideN,N-Dimethyl-p-toluidineHydroquinone	Substantially identical
Mixing/Application	Manual	Substantially identical
Powder SterilizationMethod	EtO gas	Substantially identical
Sterility AssuranceLevel (SAL) – Powder	10-6	Substantially identical
Items	Predicate Device	Proposed Device
Liquid SterilizationMethod	Filtration	Substantially identical
SAL - Liquid	10-3	Substantially identical
Biocompatibility	Biocompatible	Substantially identical
Performance	Compliance with SpecialControls Guidance document	Substantially identical

4. Device Description

5. Indications for Use

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by

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osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

6. Comparison to the Predicate Device

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XeliteMed VertehighFix High Viscosity Spinal Bone Cement has similar technological characteristics as the predicate devices including overall design, intended use, material composition, function, and range of sizes. Even though the manufacturing methods are different, this does not affect the same acceptability attributes between the product and the predicates and does not cause new issue relating to the safety or performance. The performance data demonstrate that the new devices are substantially equivalent to

the predicate device and meet the requirements of the Special Controls Guidance document.

7. Performance Data

Non-clinical tests were performed on the proposed device.

The following tests were conducted:

Setting time and Max temperature .
Dough time .
Intrusion .
BPO content ●
Barium Sulfate Content ●
Trace elements .
Residual monomer ●
Leachables ●
Molecular weights ●
NMR ●
Glass transition temperature .
Powder morphology ●
Porosity, Dimension change .
% Water Absorption ●
Stability ●
Compressive Strength & Compressive Modulus ●

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Bending Strength & Bending Modulus .
. Tensile Strength & Tensile Modulus.
Bacterial endotoxin testing was performed using the LAL test method, following . the USP <85> Bacterial Endotoxins Test, and met the limits (<20 EU/device).

Conclusion

Test data indicate that the final properties of XeliteMed VertehighFix High Viscosity Spinal Bone Cement are in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”