The F20 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

F20 is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates F20 allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. 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 liguid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. 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.

AI/ML Overview

The medical device described in the 510(k) summary is a bone cement called F20, intended for use in vertebroplasty and kyphoplasty procedures to fix pathological fractures of the vertebral body.

Here's an analysis of the acceptance criteria and study information provided in the document:

This document describes a non-clinical study for device F20 as depicted in the 510(k) summary provided.

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

The F20 bone cement’s performance was evaluated against the standards outlined in ISO 5833 "Implants for surgery - acrylic resin cements". The acceptance criteria are implicitly defined by compliance with this standard and similarity to predicate devices.

Acceptance Criteria (Implicit from ISO 5833 & Predicate Comparison)	Reported Device Performance (F20)
Chemical Composition	Compliant with ISO 5833, similar to predicate devices
Powder Morphology	Compliant with ISO 5833, similar to predicate devices
Molecular Weights	Compliant with ISO 5833, similar to predicate devices
Handling Times	Compliant with ISO 5833, similar to predicate devices
Compressive Strength	Performed (per ISO 5833), compliant, similar to predicate devices
Dynamic Fatigue Test (Compression)	Performed, compliant, similar to predicate devices
Flexural Strength	Performed (per ISO 5833), compliant, similar to predicate devices
Flexural Modulus	Performed (per ISO 5833), compliant, similar to predicate devices
Viscosity or Extrusion Forces during Injection Phase	Performed, compliant, similar to predicate devices
Setting Time vs. Temperature	Performed, compliant, similar to predicate devices
Radiopacity	Performed, compliant, similar to predicate devices (high amount of radiopaque agent specifically mentioned in description)
Monomer Elution Testing	Performed, compliant, similar to predicate devices

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of samples for compressive strength testing). It only states that tests were "conducted."

The data provenance is from non-clinical laboratory testing conducted by Teknimed SAS, the manufacturer, in France. The specific nature of the data is experimental results from material science and mechanical engineering tests.

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

This information is not applicable as there was no clinical study. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards (ISO 5833) and the performance characteristics of the predicate devices. The experts involved would be the engineers and scientists conducting these tests, but their number and qualifications are not specified.

4. Adjudication method for the test set

This information is not applicable as there was no clinical study involving subjective interpretation. The assessment was based on objective measurements against ISO 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone cement, not an AI-assisted diagnostic tool.

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

No, this is not an AI algorithm. The performance evaluation was of the physical and chemical properties of the bone cement in a standalone non-clinical setting.

7. The type of ground truth used

The "ground truth" for the non-clinical tests was based on:

Established scientific and engineering standards: Specifically ISO 5833 "Implants for surgery - acrylic resin cements."
Performance characteristics of legally marketed predicate devices: Vertecem (K090435), Opacity+ (K080873), and Spine-Fix® (K045593). The F20 was shown to have similar properties to these predicates.

8. The sample size for the training set

This information is not applicable as this is not a machine learning or AI device. There is no concept of a "training set" for the evaluation of a bone cement's physical and chemical properties.

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

This information is not applicable as this is not a machine learning or AI device.

Summary

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510(k) Summary for the F20

K103'433

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the F20

Date Prepared: November 15, 2010

1. Submitter: Teknimed SAS 11 rue Apollo Z.I. Montredon 31240 L'Union France
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Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199

JAN - 3 2011

1. Trade name: Common Name: Classification Name:
  F20 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:

F20 is a modification of the following bone cements: Vertecem (K090435. Teknimed) Opacity+ (K080873, Teknimed) Spine-Fix® (K045593, Teknimed)

4. Description of the device:

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. F20 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 liguid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. F20 is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates F20 allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.

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.

5. Substantial equivalence claimed to predicate devices

F20 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 theF20 to these predicate devices.

Items	Device NameF20	Vertecem	Opacity+	Spine-Fix
Sponsor	Teknimed	Teknimed	Teknimed	Teknimed
510(k) Number	--	K090435	K080873	K045593
Device ClassificationName	Cement	Bone	Vertebroplasty	Cement

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DeviceName	F20	Vertecem	Opacity+	Spine-Fix®
Items
Product Code	NDN	NDN	NDN	NDN
Regulation #	Class II per 21 CFRsection 888.3027	Class II per 21 CFRsection 888.3027	Class II per 21 CFRsection 888.3027	Class II per 21 CFRsection 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

e. Intended Use:

The F20 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 compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

7. Non-clinical Test Summary:

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 t
. Setting time vs. temperature
. Radiopacity
. Monomer elution testing

Test data indicate that the final properties of F20 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.

8. Clinical Test Summary:

No clinical studies were performed

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9. Conclusions Nonclinical and Clinical:

..............................................................................................................................................................................

The F20 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

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

JAN - 3 2011

Re: K103433

Trade/Device Name: F20 Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: December 20, 2010 Received: December 27, 2010

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 Ameridments, 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. Iisting 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 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/Reportal?roblem/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,

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:

Indications For Use:

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 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 K103433

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.”