PALACOS ® MV 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.

Device Description

PALACOS® MV 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. It is currently marketed in a 44 g packaging size in the United States.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called PALACOS® MV, which is a polymethylmethacrylate (PMMA) bone cement. This document details the device's characteristics and its substantial equivalence to a predicate device, but does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the rigorous validation of AI/ML-based medical devices for regulatory clearance. Since PALACOS® MV is a physical bone cement, these types of evaluations are not applicable.

Instead, the document focuses on demonstrating the substantial equivalence of PALACOS® MV to a previously cleared predicate device (Palamed®, K030904) through preclinical testing of its physical and mechanical properties. The "acceptance criteria" in this context would refer to the standards outlined in ISO 5833 and Heraeus's internal final test requirements, which the device met.

Here's an attempt to answer the questions based on the provided text, while highlighting the irrelevance of some questions to this type of device:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standards Met)	Reported Device Performance (PALACOS® MV)
ISO 5833	Doughing time, maximum temperature, setting time, intrusion, compressive strength, bending modulus, and 4-point bending strength were characterized. Met ISO 5833 standards.
Heraeus final test requirements	Tested for impact and bending strength (Dynstat test method). Met Heraeus final test requirements.
ANSI/AAMI ST72:2011 (Bacterial Endotoxin Test)	Bacterial endotoxin evaluated (LAL test). Test results met endotoxin limits (20 endotoxin units (EU)/Device).
Stability/Shelf Life	Data compared between subject and predicate devices. No specific quantitative criteria or results are detailed beyond "data were also compared".

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the preclinical tests conducted to characterize the physical and mechanical properties of the bone cement. The tests were presumably conducted in a laboratory setting, likely in Germany, where Heraeus Medical GmbH is located. This would be considered prospective controlled laboratory testing, not data provenance in the AI/ML sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant for evaluating the physical properties of bone cement. The "ground truth" for bone cement performance is based on established engineering and materials science principles, and international standards (like ISO 5833).
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used to resolve disagreements among human reviewers of data, particularly in complex medical image interpretation or clinical outcomes. This is not
relevant for standardized mechanical and chemical testing of a material.
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. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic tasks. This device is a physical bone cement, not an AI/ML algorithm, so an MRMC study was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The concept of "standalone performance" refers to the evaluation of an AI algorithm independent of human interaction. PALACOS® MV is a physical product. Its performance is evaluated through material science tests, not as an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of PALACOS® MV is based on objective measurements and established international standards for bone cement (e.g., ISO 5833) and bacterial endotoxin testing (ANSI/AAMI ST72:2011). This is material science and chemistry, not clinical "outcomes data" or "pathology" in the diagnostic sense.
The sample size for the training set

Not applicable. As a physical product, there is no "training set" in the context of AI/ML. The device's properties are inherent to its formulation and manufacturing process, evaluated through testing.
How the ground truth for the training set was established

Not applicable, as there is no "training set" for this device.

Summary

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

September 17, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue letters.

Heraeus Medical GmbH Ute Greiner Head of Regulatory Affairs Philipp-Reis-Straße 8/13 Wehrheim, Germany 61273

Re: K182260

Trade/Device Name: PALACOS® MV Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: August 17, 2018 Received: August 21, 2018

Dear Ute Greiner:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

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

Enclosure

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

Indications for Use

510(k) Number (if known) K182260

Device Name PALACOS® MV

Indications for Use (Describe)

PALACOS ® MV 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.

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 Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@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."

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

PALACOS® MV

Image /page/3/Picture/1 description: The image shows the logo and address of Heraeus Medical GmbH. The logo is a stylized wordmark with the company name "Heraeus" in a bold, sans-serif font. Below the logo is the company name and address, which is "Heraeus Medical GmbH, 61273 Wehrheim, Germany."

Radiopaque bone cement

510(k) Summary - K182260

Date of summary	August 17th, 2018
Device trade name	PALACOS® MV (previously named PALAMED®)
Common name	PMMA Bone Cement
Classification	PMMA Bone Cement : Class II Special Controls per21 CFR 888.3027
Classification name	Polymethylmethacrylate (PMMA) bone cement
Device product code	LOD
Identification of themarketed device to whichequivalence is claimed	Palamed®, K030904 (now named PALACOS® MV)
Contact person	Ute GreinerPhone: + 49 (0) 6181.35-2808Fax: + 49 (0) 6181.35-2947Regulatory_HM@heraeus.com
Description of the device	PALACOS® MV is an acrylic bone cement for use inorthopedic surgery. It is formed from powder andliquid by exothermic polymerization. It secures thefixation of the grafted artificial joint, improving thetransfer of forces at the interface implant - bone. It iscurrently marketed in a 44 g packaging size in theUnited States.
Indications for use	PALACOS® MV is intended for use in arthroplasticprocedures of the hip, knee, and other joints for thefixation of polymer or metallic prosthetic implantsto living bone.
Comparison oftechnologicalcharacteristics	Bone cement is derived by mixing a powdercomponent and a monomer liquid. The onlydifference between the subject and predicate deviceis the modification of the lower specification limit of the
	benzoyl peroxide (BPO) content in the powdercomponent of the finished device.
Discussion of preclinicaltests	The doughing time, maximum temperature, settingtime, intrusion, compressive strength, bendingmodulus and 4-point bending strength ofPALACOS® MV with a lower specification limit ofbenzoyl peroxide (BPO) content was characterizedper ISO 5833. In addition, impact and bendingstrength were measured according to Dynstat testmethod. Stability/shelf life data were alsocompared between the subject and predicatedevices.Bacterial endotoxin have been evaluated usingbacterial endotoxin test method (LAL test; knownas the Limulus amebocyte lysate test), inaccordance with the ANSI/AAMI ST72:2011. Testresults met the endotoxin limits for the BET: 20endotoxin units (EU)/Device.
Clinical performance data	No clinical data was provided.
Conclusions frompreclinical and clinical data	PALACOS® MV with a lower limit of benzoyl peroxide(BPO) content is substantially equivalent to thePalamed® predicate device and meets ISO 5833and Heraeus final test requirements
Applicant's name andaddress	Heraeus Medical GmbHPhilipp-Reis-Straße 8/1361273 WehrheimGermany

Page 1 of 2

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

PALACOS® MV

Image /page/4/Picture/1 description: The image shows the logo for Heraeus Medical GmbH, located in 61273 Wehrheim, Germany. The logo is in a bold, sans-serif font and is stacked on top of the company name and address. The text is black and the background is white.

Radiopaque bone cement

510(k) Summary - K182260

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.”