BonOs R Genta 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 when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.

Device Description

BonOs R Genta is a fast-setting acrylic resin with the addition of gentamicin sulfate for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radiopaque bone cement which fixes the implant and transfers stresses evenly to the bone.

AI/ML Overview

The provided text describes the BonOs R Genta bone cement and claims substantial equivalence to the predicate device Palacos R+G. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report.

Instead, the document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new efficacy study with defined acceptance criteria. The equivalence here is based on material composition, mechanical safety, and performance characteristics compared to an existing device, not on clinical performance against a specific set of outcomes with acceptance thresholds.

Therefore, the requested information cannot be fully extracted from the provided text. I will explain what information is present and what is missing.

Missing Information:

1. A table of acceptance criteria and the reported device performance: This is not present as it's not a clinical performance study.
2. Sample size used for the test set and the data provenance: No test set in the context of clinical performance is described. The "test set" for equivalence was likely material testing and characterization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it's not a diagnostic or prediction study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is a bone cement, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical ground truth for a diagnostic device. The "ground truth" here is the established properties of the predicate device.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding "study" and "criteria":

The document claims substantial equivalence based on:

Scientific concepts, significant physical and performance characteristics: The device is described as a self-polymerizing two-component system, similar to other bone cements.
Summary of technological characteristics: A direct comparison table is provided between BonOs R Genta and the predicate device Palacos R+G.
- Shared characteristics: Common name (PMMA Bone Cement), Responsible manufacturer (aap Biomaterials vs. Heraeus Kulzer), Product Code (LOD, MBB), Classification (Class II), Regulation no. (21 CFR 888.3027), Materials (Polymer, Initiator, Radiopacifier, Antibiotic, Monomer, Activator).
- Specific material comparison:
  - Powder: Both use Poly(methyl acrylate, methyl methacrylate) polymer, Di-benzoyl peroxide initiator, Zirconium dioxide radiopacifier, and Gentamicin antibiotic.
  - Liquid: Both use Methylmethacrylate (stabilized with hydroquinone) monomer and N,N-dimethyl-p-toluidine activator.
  - Note: Palacos R+G is mentioned to contain "Chlorophyll Copper Complex," which is not listed for BonOs R Genta, but the overall conclusion is still substantial equivalence.
Equivalence verification: "Equivalence was verified by physical, chemical and mechanical comparative tests to Palacos R+G." This implies laboratory-based testing of properties rather than a clinical trial. The specific results of these tests are not provided in this summary.

Conclusion:

This document is a regulatory submission demonstrating substantial equivalence for a bone cement based on material composition and physical/mechanical properties compared to a predicate device. It does not contain information about clinical performance against specific acceptance criteria, nor does it describe a clinical study with human subjects, expert adjudication, or AI performance metrics.

Summary

{0}------------------------------------------------

aap Biomaterials GmbHLagerstraße 11 – 1564807 DieburgGermany	BonOs R Genta	164-0059-02
5. 510(k) Summary		Date of issue:07.12.2012
510(k) Premarket Notification PO-35		page 1 of 3

5. 510(k) summary

7 2013 MAR

ાર

Preparation date:	07.12.2012
Submitter:	aap Biomaterials GmbHLagerstraße 11-1564807 DieburgGermanyPhone: +49 6071 / 929-0Fax: +49 6071 / 929-100
Contact person:	Volker Stirnal
Trade name:	BonOs R Genta
Common name:	PMMA Bone Cement
Classification:	Polymethylmethacrylate (PMMA) Bone Cement21 CFR 888.3027, Class II
Product Code:	LOD, Bone CementMBB, Bone Cement, Antibiotic
Panel:	Orthopedics

Predicate device to which substantial equivalence is claimed:

Manufacturer	Device Name	510(k) #
Heraeus	Palacos R+G	(K031673)

{1}------------------------------------------------

aap Biomaterials GmbHLagerstraße 11 – 1564807 DieburgGermany	BonOs R Genta5. 510(k) Summary510(k) Premarket Notification PO-35	164-0059-02Date of issue:07.12.2012page 2 of 3
--------------------------------------------------------------------------	-------------------------------------------------------------------------------	--------------------------------------------------------------------

Device description:

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 an 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 paste is obtained which can be introduced into bone 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 fix the implant. The setting or curing time is greatly influenced by the temperature of the components and environment, which is common for all acrylic bone cements.

Statement of the intended use:

The BonOs R Genta bone cement 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 when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.

{2}------------------------------------------------

aap Biomaterials GmbHLagerstraße 11 – 1564807 DieburgGermany	BonOs R Genta5. 510(k) Summary510(k) Premarket Notification PO-35	164-0059-02Date of issue:07.12.2012page 3 of 3
--------------------------------------------------------------------------	-------------------------------------------------------------------------------	----------------------------------------------------------------

3 3

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

BonOs R Genta bone cement comprises the same materials, mechanical safety and performance as the legally marketed devices Palacos R+G.

Trade Name	BonOs R Genta	Palacos R+G
Common name	PMMA BoneCement	PMMA BoneCement
Responsiblemanufacturer	aap Biomaterials	Heraeus Kulzer
510(k) Number	-	K031673
Device ClassificationName	Cement, Bone	Cement, Bone
Product Code	LOD, MBB	LOD, MBB
Classification	Class II	Class II
Regulation no.	21 CFR 888.3027	21 CFR 888.3027
MaterialPowder	Polymer	Poly(methyl acrylate, methyl methacrylate)	Poly(methyl acrylate, methylmethacrylate)*
	Initiator	Di-benzoylperoxide	Di-benzoylperoxide
	Radiopacifier	Zirconium dioxide	Zirconium dioxide
	Antibiotic	Gentamicin	Gentamicin
Liquid	Monomer	Methylmethacrylate(stabilized withhydroquinone)	Methylmethacrylate(stabilized withhydroquinone)*
	Activator	N,N-dimethyl-p-toluidine	N,N-dimethyl-p-toluidine

contains Chlorophyll Copper Complex

BonOs R Genta is substantially equivalent to Palacos R Genta (K031673)in regard to intended use, materials and operational principles as a bone cement. Equivalence was verified by physical, chemical and mechanical comparative tests to Palacos R+G.

In summary, BonOs R Genta bone cement is as safe and effective for the declared indications as the predicate devices Palacos R+G.

5 - 3

{3}------------------------------------------------

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-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

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

March 7, 2013

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

Re: K123081

Trade Name: BonOs R Genta Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, MBB Dated: January 25, 2013 Received: January 28, 2013

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

{4}------------------------------------------------

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,

Erin DKeith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

aap Biomaterials GmbH
Lagerstraße 11 – 15
64807 Dieburg
Germany

BonOs R Genta
4. Indications for Use Statement

510(k) Premarket Notification PO-35
-------------------------------------

	164-0058-01
Date of issue:	27.09.2012

4. Indications for Use

K123081 510(k) Number:

Device Name:

BonOs R Genta

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123081

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.”