Cemex System Genta Fast Bone Cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

The individual chemical constituents in Cemex System Genta Fast bone cement are identical to those in the predicate Centa / Cemex System Genta bone cement (#K033596). The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate, benzoyl peroxide and gentamicin sulphate. The only difference is that the predicate Cemex Genta / Cemex Genta System has a 2.7:1 powder-to-liquid ratio compared to the 2.4:1 ratio the new Cemex System Genta Fast product. The powder-to-liquid ratio reduction results in a quicker setting time to accommodate various application techniques. Use of Cemex System Genta Fast bone cement takes place in two consecutive stages. During the first stage, the glass ampoule containing the liquid monomer is broken to allow the component to flow into the chamber containing the powdered constituents. The device is then used as a closed manual mixing device. Mixing is accomplished by firmly striking the device against the palm of the hand and mating at each strike. In re second stage, the container is attached to an application gun device and used as a syringe while the cement is still in a semi-fluid state.

AI/ML Overview

The provided document is a 510(k) summary for the Tecres Cemex® System Genta Fast bone cement. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML medical device.

The document discusses the physical and chemical properties of the bone cement and its comparison to a predicate device. The "performance testing" mentioned refers to engineering and material science tests to ensure the bone cement meets specific standards (ISO 5833 and ASTM 451-99) and that gentamicin release is comparable to the predicate. This is typical for a traditional medical device, not an AI/ML device.

Therefore, I cannot provide the requested information for an AI/ML device based on the given input, as the document does not describe such a device or study.

Here's why the specific questions cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: The document states that "Performance testing shows that the proposed device is equivalent to the predicate and meet the requirements of ISO 5833 and ASTM 451-99." It also mentions "gentamicin release is within the safety range and comparable to the predicate Cemex Genta." This refers to material and chemical properties, not diagnostic performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI/ML device. Specific numerical acceptance criteria or performance metrics for these standards are not detailed in this summary.
Sample sized used for the test set and the data provenance: Not applicable, as this is a non-AI bone cement. No "test set" of patient data is mentioned for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would be established by human experts or pathology, which is not relevant here.
Adjudication method: Not applicable. This relates to expert review in AI/ML studies.
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: Not applicable. This is for AI-assisted human reading.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This describes AI performance without human intervention.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a bone cement, "ground truth" would relate to its physical properties meeting specifications, potentially in vivo performance in animal studies or clinical trials for safety and efficacy, but not in the sense of diagnostic ground truth for an AI/ML system.
The sample size for the training set: Not applicable. No AI model is trained here.
How the ground truth for the training set was established: Not applicable. No AI model is trained here.

Summary

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K043403.

2320 NW 66TH COURI GAINESVILIE, FL 32653

352-377-1140 FAX 352-378-2617

Tecres Cemex® System Genta Fast bone cement Special 510(k)

DEC: 2 8 2004

Summary of Safety and Effectiveness

Trade Names:	Cemex System Genta Fast bone cement
Common Name:	Bone Cement
Classification Name:	Polymethylmethacrylate (PMMA)Bone Cement

Legally Marketed Device for Substantial Equivalence Comparison:

Model	Manufacturer	510(k) Number
Cemex GentaCemex System Genta	Tecres, S.p.A.	#K033596

INDICATIONS FOR USE

CONTRAINDICATIONS

Cemex System Genta Fast Bone Cement is contraindicated in primary orthopaedic musculoskeletal surgical procedures.

Cemex System Genta Fast Bone Cement is contraindicated in patients who are allergic or sensitive to any of its components, including Gentamicin Sulphate.

If the patient has a history of hypersensitivity or serious toxic reactions to aminoglycosides, the use of any other aminoglycosides may also be contraindicated due to the known cross-sensitivity of patients to drugs in this class.

Cemex System Genta Fast Bone Cement is contraindicated in the presence of active or incompletely treated infection, at the site where the bone cement is to be applied.

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Section 4 Page 2 of 4

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Tecres Cemex® System Genta Fast bone cement Special 510(k)

352 377-1140 י FAX 352-378-26 ד

Summary of Safety and Effectiveness

Cemex System Genta Fast Bone Cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.

Cemex System Genta Fast Bone Cement must be considered carefully in the presence of mvastenia gravis.

There may be increased risk of oto:oxicity from gentamicin, if other ototoxic drugs such as cisplatin (an antineoplatic agent) and vancomycin (another antibiotic) are given at the same time. There also appears to be a synergistic effect of loop diuretics, such as furosemide or ethacrynic acid, and also loud noise, when combined with gentamicin.

GENERAL DESCRIPTION - Substantial Equivalency Information

The only difference is that the predicate Cemex Genta / Cemex Genta System has a 2.7:1 powder-to-liquid ratio compared to the 2.4:1 ratio the new Cemex System Genta Fast product. The powder-to-liquid ratio reduction results in a quicker setting time to accommodate various application techniques,

Performance testing shows that the proposed device is equivalent to the predicate and meet the requirements of ISO 5833 and ASTM 451-99. Performance testing shows that the rate of gentamicin release is within the safety range and comparable to the predicate Cemex Genta.

PACKAGING

Cemex System Genta Fast bone cement is packaged similarly to the predicate Cemex System Genta bone cement. The device is contained into the same double blister pack used for the predicate. The blisters are sealed with Tyvek® lids. The double blister pack is positioned inside an aluminum bag. The outer packaging is a heavy weight cardboard box.

MIXING & APPLICATION

Use of Cemex System Genta Fast bone cement takes place in two consecutive stages. During the first stage, the glass ampoule containing the liquid monomer is broken to allow the component to flow into the chamber containing the powdered constituents. The device is then

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Section 4 Page 3 of 4

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Tecres Cemex® System Genta Fast bone cement Special 510(k)

Summary of Safety and Effectiveness

used as a closed manual mixing device. Mixing is accomplished by firmly striking the device against the palm of the hand and mating at each strike. Because no direct contact is made between the components and the use , volitile release into the local environment and possibility of contamination is minimized. In re second stage, the container is attached to an application gun device and used as a syringe while the cement is still in a semi-fluid state. The transparency of the mixing device provides for preliminary inspection of the suitability of the cement components and the visualization of he mixing and application stages as required by ISO 5833. Detailed instructions for use and pr >aution/warning information is outlined in the instruction leaflet provided with the product.

STERILITY ASSURANCE

The powdered component is steriliz. d by ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10 °. The liquid component is sterilized by a membrane filtration technique to a SAL of 10-3.

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Section 4 Page 4 of 4

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2004

Ms. Lisa Simpson Sr. Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K043403

Trade Name: Cemex System Genta Fast Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: December 16, 2004 Received: December 20, 2004

Dear Ms. Simpson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
b. Mark A. Melkman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tecres Cemex® System Genta Fast Bone Cement Indications for Use

510(k) Number:

K043403

Device Names:

Cemex System Genta Fast Bone Cement

INDICATIONS FOR USE

CONTRAINDICATIONS

Cemex System Genta Fast Bone Cement is contraindicated in primary orthopaedic musculoskeletal surgical procedures.

Cemex System Genta Fast Bone Cement is contraindicated in patients who are allergic or sensitive to any of its components, including Gentamicin Sulphate.

Cemex System Genta Fast Bone Cement is contraindicated in the presence of active or incompletely treated infection, at the site where the bone cement is to be applied.

Cemex System Genta Fast Bone Cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.

Cemex System Genta Fast Bone Cement must be considered carefully in the presence of myastenia gravis.

There may be increased risk of ototoxicity from gentamicin, if other ototoxic drugs such as cisplatin (an antineoplatic agent) and vancomycin (another antibiotic) are given at the same time. There also appears to be a synergistic effect of loop diuretics, such as furosemide or ethactynic acid, and also loud noise, when combined with gentamicin.

X Over the Counter Use Prescription Use Or

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

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Page 1 of 1

510(k) Number K043403

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.”