PALACOS® R+G pro is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The bone cement powder and liquid of PALACOS® R+G pro are pre-packed in a vacuum mixing and application system. This reduces the user steps and processing time during mixing of the bone cement. It also decreases the exposure to monomer fumes. PALACOS® R+G pro is available in one size: 75 g and is for single use. The PALACOS® R+G pro device includes: The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun

AI/ML Overview

Based on the provided text, the device is PALACOS® R+G pro, a radiopaque bone cement with gentamicin. This document is a 510(k) summary for its premarket notification.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format as would be seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it describes a series of nonclinical tests performed according to international standards (ISO standards) to demonstrate that the PALACOS® R+G pro is substantially equivalent to a legally marketed predicate device (PALACOS® R+G, K031673). The reported device performance is that it characterized per ISO 5833, measured according to Dynstat test method, validated per ISO 11135, and performed per ISO 10993. The conclusion is that it is "substantial equivalent to PALACOS® R+G."

Given the nature of this medical device (bone cement), the "acceptance criteria" are implied by compliance with these standards and the demonstration of substantial equivalence.

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Stability of liquid components	Characterized per ISO 5833
Maximum temperature	Characterized per ISO 5833
Setting time	Characterized per ISO 5833
Intrusion	Characterized per ISO 5833
Compressive strength	Characterized per ISO 5833
Bending modulus	Characterized per ISO 5833
Bending strength	Characterized per ISO 5833
Impact strength	Measured by Dynstat method
EtO sterilization validation	Validated per ISO 11135
Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation, genotoxicity, chemical characterization)	Performed per ISO 10993

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

The document indicates that nonclinical tests were performed. No specific sample sizes for these tests (e.g., number of test specimens for mechanical strength) are detailed in this summary. The data provenance is from Heraeus Medical GmbH, Germany. The tests are inherently prospective as they are conducted specifically for the purpose of demonstrating equivalence for this new product.

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

This question is not applicable. The device is a bone cement, not a diagnostic or AI device that requires expert adjudication for ground truth establishing. The "ground truth" for this device's performance is established through physical and biological testing against established standards, not expert consensus on medical images or clinical outcomes.

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

This question is not applicable for the same reasons as point 3. Testing of physical properties and biocompatibility does not involve human adjudication in the described manner.

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 device is a bone cement, not an AI or diagnostic tool. No MRMC study was performed or is relevant for this device.

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

This question is not applicable. The device is a bone cement, not an algorithm.

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

For a bone cement, the "ground truth" for its performance and safety is established through:

Compliance with international standards: ISO 5833 for mechanical properties, ISO 11135 for sterilization, and ISO 10993 for biocompatibility.
Physical and chemical characterization: Direct measurements of properties like stability, temperature, setting time, strength, etc.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" for a physical medical device like bone cement. The manufacturing process and formulation are developed, and then the final product is tested against standards.

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

This question is not applicable for the same reason as point 8.

Summary

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

September 5, 2014

Heraeus Medical GmbH Dr. Astrid Marx Junior Regulatory Affairs Manager Philipp-Reis-Straße 8/13 61273 Wehrheim Germany

Re: K142157

Trade/Device Name: PALACOS® R+G pro Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, MBB, KIH, JDZ Dated: July 25, 2014 Received: August 6, 2014

Dear Dr. Marx

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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K142157

Device Name PALACOS® R+G pro

Indications for Use (Describe)

PALACOS® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a bold, sans-serif font in gray color. Below the logo, the words "Heraeus Medical GmbH" are written in a smaller, sans-serif font in black color.

61273 Wehrheim, Germany

PALACOS® R+G pro

Radiopaque bone cement with gentamicin

Special 510(k)	510(k) Summary
Date of summary	July 25th, 2014
Applicant's name and address	Heraeus Medical GmbHPhilipp-Reis-Straße 8/1361273 WehrheimGermany
Device trade name	PALACOS® R+G pro
Common name	PMMA Bone Cement
Classification	PMMA Bone Cement : Class II special control per 21 CFR888.3027Cement Mixer for Clinical Use: Class I Exempt per 21 CFR888.4210Cement Dispenser: Class I Exempt per 21 CFR 888.4200
Classification name	Polymethylmethacrylate (PMMA) bone cement
Device code	LOD, MBB, KIH, JDZ
Identification of the marketeddevice to which equivalence isclaimed	PALACOS® R+G, K031673
Reference device	SmartMix Cemvac Pre-filled with SmartSet GHVGentamicin bone cement, K053445
Description of the device	PALACOS® R+G pro is an acrylic bone cement for use inorthopedic surgery. It is formed from powder and liquid byexothermic polymerization. It secures the fixation of thegrafted artificial joint improving the transfer of forces at theinterface implant - bone. The bone cement powder andliquid of PALACOS® R+G pro are pre-packed in a vacuummixing and application system. This reduces the user stepsand processing time during mixing of the bone cement. Italso decreases the exposure to monomer fumes.PALACOS® R+G pro is available in one size: 75 g and is
Special 510(k)	510(k) Summary
	for single use. The PALACOS® R+G pro device includes:The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun
Indications for use	PALACOS® R+G pro is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Comparison of technologicalcharacteristics	Bone cement is derived by mixing a powder component and a monomer liquid. The only difference between the subject and predicate device exists in a change to the primary packaging into a pre-packed application device to simplify the user handling of the components.
Discussion of nonclinical tests	The stability of liquid component, maximum temperature, setting time, intrusion, compressive strength, bending modulus and bending strength of PALACOS® R+G pro was characterized per ISO 5833. In addition, impact and bending strength were measured according to Dynstat test method. EtO sterilization was validated per ISO 11135. Biocompatibility testing, including cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation, genotoxicity and chemical characterization was performed per ISO 10993.
Clinical performance data	No clinical data was provided.
Special 510(k)	510(k) Summary
Conclusions from nonclinicaland clinical data	PALACOS® R+G pro is substantial equivalent toPALACOS® R+G.
Submitted by	Dr. Astrid MarxPhone: + 49 (0) 6181.35-2963Fax: + 49 (0) 6181.35-2910astrid.marx@heraeus.com
US contact information	Aptiv Solutions,62 Forest Street, Suite 300, Marlborough, MA 01752,Tina Wu (Phone: +1 443.352.3909,tina.wu@aptivsolutions.com)

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Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a bold, sans-serif font in a dark gray color. Below the logo is the text "Heraeus Medical GmbH" in a smaller, black font. There is a thin black line underneath the text.

61273 Wehrheim, Germany

PALACOS® R+G pro

Radiopaque bone cement with gentamicin

Special 510(k) – 510(k) Summary, Page 2

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Heraeus

Heraeus Medical GmbH

61273 Wehrheim, Germany

PALACOS® R+G pro

Radiopaque bone cement with gentamicin

25 July 2014

Special 510(k) – 510(k) Summary, Page 3

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.”