The Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Device Description

Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body using a Vertebroplasty or Kyphoplasty procedure.

The Vertecem II Mixing Kit consists of sterile packed components. When the cement components are mixed together, they become a self hardening, radioopaque bone cement.

Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.

The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as initiator is included.

The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.

When the powder and liquid components are mixed together, the activator DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - D.

As a result, a viscous injectable paste is obtained which can be introduced into a vertebral body using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. After curing the bone cement is able to stabilize the vertebral lesions and vertebral compression fractures. The setting or curing time is greatly influenced by the temperature of the components and environment, which is common for all acrylic bone cements.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Vertecem II Mixing Kit, a PMMA bone cement. It is not an AI/ML device, therefore, the requested information regarding acceptance criteria, study data analysis, and expert involvement is not applicable. The device relies on physical, chemical, and mechanical comparative tests to establish substantial equivalence to predicate devices, not on AI/ML performance metrics.

Summary of Device and Regulatory Context:

The Vertecem II Mixing Kit is a radio-opaque, injectable acrylic bone cement designed for Vertebroplasty or Kyphoplasty procedures to treat pathological vertebral body fractures (e.g., from osteoporosis, hemangioma, metastatic cancers, myeloma). The 510(k) submission seeks to demonstrate substantial equivalence to two predicate devices: Vertecem (K090435) and BonOs Inject (K090460).

Acceptance Criteria and Device Performance (Not Applicable - Non-AI/ML Device):

This device is a medical material (PMMA bone cement) and its regulatory clearance is based on demonstrating substantial equivalence to existing predicate devices through physical, chemical, and mechanical comparative tests, not on an algorithm's performance in a diagnostic or predictive task. Therefore, the concept of "acceptance criteria" for AI/ML performance metrics, such as sensitivity, specificity, or AUC, and the associated study designs (e.g., MRMC studies, standalone studies) are not applicable.

The document states: "The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data."

Table of Comparison (Based on the provided text, but note this is for material properties, not AI/ML performance):

Criterion/Characteristic	Vertecem II Mixing Kit Performance	Predicate Device (Vertecem) Performance	Predicate Device (BonOs Inject) Performance
Material Composition	Same as predicate devices	(Implicitly similar)	(Implicitly similar)
Mechanical Safety	Same as predicate devices	(Implicitly similar)	(Implicitly similar)
Performance	Same as predicate devices	(Implicitly similar)	(Implicitly similar)
Physical Properties	Comparatively tested	Comparatively tested	Comparatively tested
Chemical Properties	Comparatively tested	Comparatively tested	Comparatively tested
Mechanical Properties	Comparatively tested	Comparatively tested	Comparatively tested

(Note: The document states "Vertecem II bone cement comprises the same materials, mechanical safety and performance as the legally marketed devices BonOs Inject and Vertecem," and "The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data." Specific numerical values for these properties are not provided in the summary, but were part of the full submission.)

Regarding the specific questions about AI/ML device studies:

Sample size for the test set and data provenance: Not applicable. The study involved comparative physical, chemical, and mechanical testing of the bone cement, not a test set of data for an AI algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of material science refers to validated laboratory test results and established material standards, not expert consensus on medical images or patient outcomes.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating observer performance with AI assistance, which is irrelevant for a bone cement product.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
The type of ground truth used: For bone cements, the "ground truth" would be established physical, chemical, and mechanical properties determined through standardized testing methods, such as those outlined in ISO or ASTM standards, and their comparison to the predicate devices and regulatory requirements. It is a material science "ground truth," not a clinical "ground truth" established by experts.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

Summary

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aap Biomaterials GmbHLagerstraße 11 – 1564807 DieburgGermany	Vertecem II Mixing Kit	K121876
5. 510(k) Summary	164-0008-01Date of issue:2 2. Juni 2012
510(k) Premarket Notification PO-32	page 1 of 3

5. 510(k) summary

OCT 1 9 2012

Preparation date:	June 22, 2012
Submitter:	aap Biomaterials GmbHLagerstraße 11-1564807 DieburgGermanyPhone: +49 6071 / 929-0Fax: +49 6071 / 929-100
Contact person:	Volker Stirnal
Trade name:	Vertecem II Mixing Kit
Common name:	PMMA Bone Cement (For Vertebroplasty)
Classification:	Polymethylmethacrylate (PMMA) Bone Cement21 CFR 888.3027, Class II
Product Code:	LOD, NDN
Panel:	Orthopedics

Predicate device to which substantial equivalence is claimed:

Manufacturer	Device Name	510(k) #
Teknimed S.A.S.	Vertecem	(K090435)
Manufacturer	Device Name	510(k) #
aap Biomaterials	BonOs Inject	(K090460)

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		K 121876
aap Biomaterials GmbHLagerstraße 11 – 1564807 DieburgGermany	Vertecem II Mixing Kit5. 510(k) Summary510(k) Premarket Notification PO-32	164-0008-01Date of issue:22. Juni 2012page 2 of 3

Device description:

Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body using a Vertebroplasty or Kyphoplasty procedure.

The Vertecem II Mixing Kit consists of sterile packed components. When the cement components are mixed together, they become a self hardening, radioopaque bone cement.

Scientific concepts, significant physical and performance characteristics:

Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.

The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as initiator is included.

The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.

Statement of the intended use:

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aap Biomaterials GmbHLagerstraße 11 – 1564807 DieburgGermany	Vertecem II Mixing Kit5. 510(k) Summary510(k) Premarket Notification PO-32	164-0008-01Date of issue:2 2. Juni 2012page 3 of 3
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VI91471

Summary of technological characteristics of the new device in comparison to the predicate devices:

Vertecem II bone cement comprises the same materials, mechanical safety and performance as the legally marketed devices BonOs Inject and Vertecem.

Trade Name	Vertecem II Mixing Kit	Vertecem	BonOs Inject
Common name	PMMA BoneCement	PMMA BoneCement	PMMA BoneCement
Responsiblemanufacturer	aap Biomaterials	Teknimed S.A.S.	aap Biomaterials
510(k) Number	-	K090435	K090460
DeviceClassificationName	Cement, Bone,Vertebroplasty	Cement, Bone,Vertebroplasty	Cement, Bone,Vertebroplasty
Product Code	NDN	NDN	NDN
Classification	Class II	Class II	Class II
Regulation no.	21 CFR 888.3027	21 CFR 888.3027	21 CFR 888.3027

The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data.

In summary, Vertecem II Bone Cement is as safe and effective for the declared indications as the predicate devices BonOs Inject and Vertecem.

In conclusion substantially equivalence has been demonstrated for Vertecem II Mixing Kit in comparison to Vertecem (K090435) and BonOs Inject (K090460).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

aap Biomaterials GmbH % Mr. Volker Stirnal Director, Quality Assurance and Regulatory Affairs Lagerstrasse 11-15 Dieburg, Germany D-64807

Re: K121876

Trade/Device Name: Vertecem II Mixing Kit Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MDN, LOD Dated: October 15, 2012 Received: October 16, 2012

Dear Mr. Stirnal:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

OCT 1 9 2012

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Page 2 - Mr. Volker Stirnal

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part. 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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aap Biomaterials GmbHLagerstraße 11 – 15	Vertecem II Mixing Kit	164-0007-01
64807 DieburgGermany	4. Indications for Use Statement	Date of issue:22. Juni 2012
	510(k) Premarket Notification PO-32

4. Indications for Use

510(k) Number:

Device Name:

Vertecem II Mixing Kit

Indications for Use:

Samuel D. Payne

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121876

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.”