Refobacin Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

Refobacin® Bone Cement R is a fast setting acrylic cement containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X-ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.

AI/ML Overview

This document describes the 510(k) premarket notification for Refobacin® Bone Cement R, a polymethylmethacrylate (PMMA) bone cement, and its substantial equivalence to the predicate device PALACOS® G.

Acceptance Criteria and Study Details:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on performance against specific acceptance criteria for a novel device. As such, the structure of the provided information is geared towards comparing the subject device to its predicate.

Here's an attempt to extract and organize the information based on your request, understanding that a direct "acceptance criteria" table and a "study proving performance" in the typical sense for a brand new AI/diagnostic device are not present in this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Implicit - Substantial Equivalence to Predicate)	Reported Device Performance (Refobacin® Bone Cement R)
Mechanical Properties	Comparable to PALACOS® G	"The results showed that Refobacin® Bone Cement R possesses mechanical... characteristics necessary to fulfill the intended use." (Reported as compliant and comparable)
Chemical Properties	Comparable to PALACOS® G	"The results showed that Refobacin® Bone Cement R possesses... chemical... characteristics necessary to fulfill the intended use." (Reported as compliant and comparable)
Physical Properties	Comparable to PALACOS® G	"The results showed that Refobacin® Bone Cement R possesses... physical... characteristics necessary to fulfill the intended use." (Reported as compliant and comparable)
Handling Characteristics	Comparable to PALACOS® G	"The results showed that Refobacin® Bone Cement R possesses... handling characteristics necessary to fulfill the intended use." (Reported as compliant and comparable)
Bacterial Endotoxin Limit	Met pyrogen limit specifications	"BET demonstrated the pyrogen limit specifications have been met."

Explanation: In a 510(k) submission for a bone cement, the "acceptance criteria" are implicitly tied to demonstrating that the new device is as safe and effective as a predicate device already on the market. The device performance is deemed acceptable if it performs comparably or better than the predicate across critical parameters, and meets relevant standards for safety (like endotoxin testing).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involves "comparative in-vitro testing" with the predicate device. For materials like bone cement, this typically involves a series of standardized tests (e.g., strength, fatigue, curing time, temperature release) run on multiple samples of both the subject and predicate material. The "sample size" here refers to the number of specimens tested for each characteristic.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the tests are "in-vitro," meaning conducted in a lab setting, not clinical patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a bone cement, not an AI/diagnostic device that requires expert ground truth for interpretation. The "ground truth" for its performance is established through standardized laboratory testing and material science metrics.

4. Adjudication Method for the Test Set

Not Applicable. See point 3. Testing is objective and based on established material science methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a medical device (bone cement), not an imaging or diagnostic AI system that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is a physical medical device (bone cement), not an algorithm. The in-vitro testing could be considered "standalone" in the sense that it evaluates the material properties independently of a human user; however, it's not an "algorithm-only" performance as you would describe for software.

7. The Type of Ground Truth Used

Objective Laboratory Measurements and Standards Compliance: The "ground truth" for bone cement performance is established through objective, measurable physical, chemical, and mechanical properties (e.g., compressive strength, bending strength, fatigue resistance, setting time, temperature profile, residual monomer content, radiopacity, endotoxin levels). These are compared against established industry standards and the performance of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8.

Summary from the Document:

The 510(k) submission for Refobacin® Bone Cement R relies on non-clinical comparative in-vitro testing to demonstrate substantial equivalence to PALACOS® G. The tests evaluated mechanical, chemical, physical, and handling characteristics. Additionally, Bacterial Endotoxin Testing (BET) confirmed that pyrogen limits were met. No clinical data was required for this determination. The document concludes that "Refobacin® Bone Cement R is substantially equivalent to PALACOS® G for the primary intended use of fixation of prosthetic components as described in the device labeling" due to similarities in design, function, indications for use, and fundamental scientific technology, and that it "does not introduce any new risks of safety or efficacy."

Summary

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Public Health Service

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

August 30, 2017

Biomet Inc. Ms. Heidi Busz Regulatory Affairs Associate 56 East Bell Drive Warsaw, Indiana 46581

Re: K171540

Trade/Device Name: Refobacin Bone Cement R Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB Dated: July 17, 2017 Received: July 18, 2017

Dear Ms. Busz:

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-

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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 contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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,

Katherine D. Kavlock -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		K171540Page 1 of 1Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number ( if known )	K171540
Device Name	Refobacin Bone Cement R
Indications for Use (Describe)	Refobacin Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other jointsto fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previousarthroplasty procedures due to joint infection. The cement is indicated for use in the second stage of a two stage revisionfor total joint arthroplasty after the initial infection has been cleared.
Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
	CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)		Page 1 of 1PSC Publishing Services (301) 443-6740EF

মেয়ে

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Refobacin® Bone Cement R 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact Person:	Heidi BuszRegulatory Affairs AssociateTelephone: (574-372-4249)Fax: fax (574-372-4710)
Date:	May 23, 2017
Subject Device:	Trade Name: Refobacin Bone Cement RCommon Name: Bone Cement
	Classification Name:• LOD, MBB – Polymethylmethacrylate (PMMA) bonecement (21 CFR 888.3027)
Predicate Device(s):	K031673 PALACOS® G Heraeus KulzerBone Cement GmbH & Co.The product obtained for testing and labeling comparison islabeled as PALACOS® R+G.
DeviceDescription:	Refobacin® Bone Cement R is a fast setting acryliccement containing gentamicin, for use in bone surgery.Mixing of the two component system, consisting of apowder and a liquid, produces a paste, which is used toanchor the prosthesis to the bone. The hardened bonecement allows stable fixation of the prosthesis andtransfers stresses produced in a movement to the bonevia the large interface. Insoluble zirconium dioxide isincluded in the cement powder as an X-ray contrastmedium. The chlorophyll additive in the liquid componentserves as optical marking of the bone cement at the siteof the operation.
Indications for Use:	Refobacin Bone Cement R is indicated for use as bonecement in arthroplasty procedures of the hip, knee, and

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other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage of a two stage revision for total ioint arthroplasty after the initial infection has been cleared.

Summary of Technological Characteristics:

The intended use, indications for use, materials. sterilization methods, cement design, and principle of operation of the subiect device are the same as the predicate device. Differences in size offerings and shelf life do not introduce any new risks of safety and efficacy. Refobacin® Bone Cement R is substantially equivalent to PALACOS® G for the primary intended use of fixation of prosthetic components as described in the device labeling.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests:

Comparative in-vitro testing was performed and the O results for Refobacin® Bone Cement R were compared to that of the predicate, PALACOS® G. The results showed that Refobacin® Bone Cement R possesses mechanical, chemical, physical and handling characteristics necessary to fulfill the intended use. Refobacin® Bone Cement R is substantially equivalent to PALACOS® G for the primary intended use of fixation of prosthetic components as described in the device labeling. Bacterial Endotoxin Testing (BET) O
- BET demonstrated the pyrogen limit ● specifications have been met.
Clinical Tests: ●
- Clinical data was not required to establish o substantial equivalence between the subject Refobacin® Bone Cement R and the predicate device.

Based on the similarities in design, function, indications for use and fundamental scientific technology, the subject device is similar to the predicate device and does not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject device is substantially equivalent to the predicate device.

Substantial Equivalence Conclusion

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.”