PALACOS R

• K Number: K030902
• Device Name: PALACOS R
• Manufacturer: HERAEUS KULZER GMBH & CO. KG
• Date Cleared: 2003-09-23 ( 183 days)
• Product Code: LOD
• Regulation Number: 888.3027
• Type: Abbreviated
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: K053198 , K123225 , K150119 , K172408 , K192394 , K193059 , K193061 , K202475 , K210120

Intended Use

Palacos® R 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® R 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.

AI/ML Overview

The provided text is a 510(k) summary for the Palacos® R bone cement, which is a medical device. This type of document is for regulatory clearance and does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance in the way a clinical trial or a machine learning model's validation study would.

Specifically, for a medical device cleared via the 510(k) pathway, the "acceptance criteria" are typically related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance metrics from a de novo clinical study. The "study that proves the device meets the acceptance criteria" refers to the submission of data (often pre-clinical testing or a review of existing literature/predicate device data) that supports this claim of substantial equivalence.

Therefore, many of the requested points are not applicable or cannot be extracted from this document, as it is not a report of a performance study in the context of AI/ML or a new clinical device.

Here's a breakdown based on the information provided in the 510(k) summary:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: "Substantial Equivalence" to the legally marketed predicate device, PALACOS® R BONE CEMENT (PMA Number: P810020). The specific criteria for substantial equivalence typically involve demonstrating similar technological characteristics, intended use, and safety/effectiveness profiles.
   • Reported Device Performance: The document states, "This is the well known Palacos® R being marketed for more than 25 years (PMA by Merck)." This implies that its long-standing market history and prior PMA approval serve as evidence of its performance. The 510(k) summary confirms that the device meets the requirements for substantial equivalence to its predicate.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	Device is the "well known Palacos® R being marketed for more than 25 years (PMA by Merck)" and determined substantially equivalent to PALACOS® R BONE CEMENT (PMA P810020).
Intended Use	Fixation of prostheses in bone for arthroplastic procedures.
Technological Characteristics	Similar to the predicate; formed from powder and liquid by exothermic polymerization to secure fixation.

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

   • Not applicable. This is a 510(k) summary for a bone cement, not a study involving a test set of data like in an AI/ML context. The clearance is based on comparison to a predicate device, not primary clinical data for "testing" in this manner.

3. 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. This is not an expert-driven validation study. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device as determined by the FDA (through its PMA process).

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

   • Not applicable. There is no "test set" and no adjudication process in the context of comparing human readers or AI in this 510(k) submission.

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. This is a medical device (bone cement), not an AI/ML-driven diagnostic tool that would involve human readers or MRMC studies.

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

   • Not applicable. This is a physical medical device (bone cement), not an algorithm.

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

   • The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the identified predicate device, PALACOS® R BONE CEMENT (PMA Number: P810020), which has been marketed for over 25 years and previously approved under a PMA. The substantial equivalence argument relies on the predicate's known performance rather than new, primary ground truth data from this submission.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. No training set is relevant for this type of device and submission.

Summary

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ハリロビのマイルコロレアイ

Palacos® R

SEP 2 3 2003

Applicant's name and address	Heraeus Kulzer GmbH & Co. KGGrüner Weg 11D-63450 Hanau
Contact persons	Dr. K.-D. Kühnphone: [phone]fax: [phone]. C. Tuchschererphone: [phone]fax: [phone]
Date of summary	March 18th, 2003
Device trade name	PALACOS® R
Classification name	Bone Cement
Identification of the marketed device Palacos® towhich equivalence is claimed	PALACOS® R BONE CEMENTPMA Number: P810020
Description of the device	Palacos® R 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.
Intended use	Fixation of prostheses in the bone (partial or totalhip joint replacement at the hip, knee or otherjoints).
Comparison of technological characteristics	This is the well known Palacos® R being marketedfor more than 25 years (PMA by Merck)

510(k) Summary

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ਗੱਟ

KO30902

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Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. K. D. Kühn Head of Department Heraeus Kulzer GmbH & Co. KG Grüner Weg 11 Hanau. Germany D-63450

Re: K030902

Trade/Device Name: PALACOS®R Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 25, 2003 Received: July 14, 2003

Dear Dr. Kühn:

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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Page 2 - Dr. K. D. Kühn

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millison

elia 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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Palacos® R

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Intended Use

Palacos® R 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.

for Mark N. Millman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030902

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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.”