The COHESION Bone Cement is indicated 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

The purpose of this submission is to submit a new bone cement that is a modification of Vertecem and Opacity+ bone cements, previously cleared on K090435 and K080873, respectively. Cohesion has the same indications for use as the predicate devices. Another similarity is that the cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. Cohesion is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates Cohesion allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device, specifically bone cement. It describes the device, its intended use, and compares it to previously cleared predicate devices to establish substantial equivalence.

Here's an analysis of the document to extract the requested information, specifically noting that this is not an AI/ML device, so some questions will not be applicable.

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

The document does not explicitly list "acceptance criteria" as pass/fail thresholds against specific performance metrics for the Cohesion Bone Cement. Instead, it states that the device's properties were evaluated against the "standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements'" and were found to be "in compliance" and "similar to predicate devices."

The reported device performance is indicated by the types of tests performed and the general statement of compliance.

Acceptance Criteria Category	Reported Device Performance
Compliance with ISO 5833 "implants for surgery - acrylic resin cements"	Final properties of Cohesion are in compliance with ISO 5833.
Similarity to Predicate Devices	Final properties of Cohesion are similar to predicate devices (Vertecem, Opacity+, Spine-Fix®).
Chemical Composition	PMMA based with methylmethacrylate (similar to predicates).
Powder morphology	Tested.
Molecular weights	Tested.
Handling times	Tested.
Compressive strength (per ISO 5833)	Tested and found compliant/similar.
Dynamic fatigue test compression	Performed and found compliant/similar.
Flexural strength (per ISO 5833)	Tested and found compliant/similar.
Flexural modulus (per ISO 5833)	Tested and found compliant/similar.
Viscosity or extrusion forces	Tested.
Setting time vs. temperature	Tested.
Radiopacity	Tested (Cohesion has a high amount of radiopaque agent).
Monomer elution testing	Tested.

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

This document describes a pre-market notification for a medical device (bone cement), not an AI/ML algorithm. Therefore, the concepts of "test set," "sample size," and "data provenance" in the context of AI/ML are not directly applicable.

The tests conducted are non-clinical, involving material science and mechanical properties, likely performed on manufactured samples of the bone cement in a laboratory setting. There is no information provided about the specific number of cement samples used for each test.

The data provenance for these non-clinical tests would typically be from the manufacturer's labs (Teknimed SAS, France) and could be considered prospective as they were performed to characterize the new device.

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 this device submission. This is a non-clinical evaluation of a physical medical device (bone cement) based on engineering and material science standards (ISO 5833), not an AI/ML diagnostic or prognostic tool that requires expert human interpretation to establish ground truth for a test set.

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

This question is not applicable to this device submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for AI/ML performance evaluation where disagreements among human readers need to be resolved to establish ground truth or evaluate algorithmic performance. This submission focuses on non-clinical, in-vitro material 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

This question is not applicable. The submission explicitly states: "No clinical studies were performed." Furthermore, this is a bone cement, not an AI/ML diagnostic or assistive device that would involve human readers or an MRMC study.

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

This question is not applicable. This is a physical medical device (bone cement), not an algorithm or AI system.

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

For the non-clinical tests performed, the "ground truth" (or reference standard) is the established engineering and material science standard, specifically ISO 5833 "implants for surgery - acrylic resin cements." The device's performance metrics were compared against the requirements and specifications outlined in this international standard.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable. As stated above, this is a physical medical device and does not involve AI/ML training concepts or a "training set."

Summary

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510(k) Summary for the Cohesion Bone Cement

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Cohesion Bone Cement

Date Prepared: December 20, 2010

K1.03816

FEB - 4 2011

Submitter: Teknimed SAS 11 rue Apollo Z.I. Montredon 31240 L'Union France

Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199

~~2:~~Trade name: Cohesion Bone Cement Common Name: Classification Name:

Polymethylmethacrylate (PMMA) bone cement Cement, Bone, Vertebroplasty Class II per 21 CFR section 888.3027 NDN

3. Predicate or legally marketed devices which are substantially equivalent:

Cohesion is a modification of the following bone cements: Vertecem (K090435, Teknimed) Opacity+ (K080873, Teknimed) Spine-Fix® (K045593, Teknimed)

Description of the device: 4.

Materials:

The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.

Substantial equivalence claimed to predicate devices 5.

Cohesion is substantially equivalent to the Vertecem, Opacity+ and Spine-Fix® in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the Cohesion to these predicate devices.

DeviceNameItems	Cohesion	Vertecem	Opacity+	Spine-Fix®
Sponsor	Teknimed	Teknimed	Teknimed	Teknimed
510(k) Number	--	K090435	K080873	K045593
Device ClassificationName	Cement, Bone,Vertebroplasty	Cement, Bone,Vertebroplasty	Cement, Bone,Vertebroplasty	Cement, Bone,Vertebroplasty
Product Code	NDN	NDN	NDN	NDN
Regulation #	Class II per 21 CFR	Class II per 21 CFR	Class II per 21 CFR	Class II per 21 CFR

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DeviceName	Cohesion	Vertecem	Opacity+	Spine-Fix®
Items
	section 888.3027	section 888.3027	section 888.3027	section 888.3027
Indications for Use	see below	same	same	same
Chemical Composition	PMMA based w/methylmethacrylate	PMMA based w/methylmethacrylate	PMMA based w/methylmethacrylate	PMMA based w/methylmethacrylate
Compressive strength	per ISO 5833	per ISO 5833	per ISO 5833	per ISO 5833
Dynamic testing	performed	performed	performed	performed
Flexural strength	per ISO 5833	per ISO 5833	per ISO 5833	per ISO 5833
Flexural modulus	per ISO 5833	per ISO 5833	per ISO 5833	per ISO 5833

6. Intended Use:

The Cohesion 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).

The Vertecem 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).

The Opacity+ is intended 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).

Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Non-clinical Test Summary: 7.

The following tests were conducted:

· Chemical Composition
. Powder morphology
. Molecular weights
handling times .
Compressive strength .
. Dynamic fatgue test compression
Flexural strength .
Flexural modulus .
· Viscosity or extrusion forces during the injection phase
. Setting time vs. temperature
Radiopacity .
. Monomer elution testing

Test data indicate that the final properties of Cohesion are stable and in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are similar to predicate devices.

Clinical Test Summary: 8.

No clinical studies were performed

Conclusions Nonclinical and Clinical: 9.

The Cohesion Cement is substantially equivalent to Vertecem, Opacity+ and Spine-Fix®. The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

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

Teknimed SAS % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681

FEB - 4 201

Re: K103816

Trade/Device Name: Cohesion Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: December 20, 2010 Received: January 07, 2011

Dear Mr. Webb:

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

. . . . . . . . .

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Page 2 - Mr. J.D. Webb

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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Indications for Use

510(k) Number (if known):

Device Name: COHESION Bone Cement

Indications For Use:

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

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

510(k) Number K103816

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.”