(94 days)
PALAMED® G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
PALAMED® G 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.
This document is a 510(k) premarket notification for a medical device (Palamed® G bone cement), not a study report or clinical trial. Therefore, it does not contain the structured information typically found in a study describing acceptance criteria and device performance based on a specific study.
The document primarily focuses on establishing "substantial equivalence" to a predicate device (PALACOS® R BONE CEMENT), meaning it asserts that the new device is as safe and effective as a legally marketed device.
Here's a breakdown of why the requested information is not available in this document:
- No Acceptance Criteria or Reported Device Performance Table: The document does not present a table of specific acceptance criteria (e.g., mechanical strength thresholds, elution rates, etc.) nor does it report detailed performance metrics for Palamed® G against such criteria. The comparison is made at a higher level, stating "Palamed® G performs very similar to Palacos R."
- No Specific Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth for Test or Training Sets): Since this is a 510(k) summary focusing on equivalence, it does not describe a clinical study or a detailed technical performance study with the granularity you've requested.
- There is no mention of a specific test set sample size, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
- No MRMC comparative effectiveness study is described. The concept of "human readers improving with AI" is not applicable here as Palamed® G is a bone cement, not an AI-powered diagnostic device.
- The document does not describe a "standalone" algorithm performance study for the same reason – it's a physical device, not an algorithm.
- The type of ground truth used (e.g., pathology, outcomes data) is not discussed because no such study is presented.
- There is no information on a training set sample size or how ground truth was established for a training set, as the device is not machine-learning based.
What the Document DOES provide related to performance:
- Comparison to Predicate Device: "Palamed® G is similar to Palacos R except for the additional gentamicin sulphate and a lower initial viscosity. Palamed® G performs very similar to Palacos R." This is the core "proof" of performance in a 510(k) – that it's equivalent to an already approved device.
- Intended Use: 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. This defines the clinical context in which its performance is relevant.
- Reference to another 510(k): "See also K030904 (PALAMED)." This implies that some data or comparison for a similar device (PALAMED, without the 'G' perhaps) was submitted previously, and this submission might leverage or build upon that.
In summary, this document is a regulatory submission for substantial equivalence, not a detailed technical or clinical study report. It doesn't contain the granular information about acceptance criteria and study methodologies that you are seeking. To find such information, one would typically need to review the full 510(k) submission (which is usually much more extensive than the summary provided) or any associated pre-clinical or clinical study reports that were conducted to support the safety and effectiveness claims.
{0}------------------------------------------------
ついい(K)
Palamed® G
Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. The text is slightly distressed, giving it a textured appearance. The word is horizontally oriented and fills the majority of the frame.
510(k) Summary
| Date of summary | Mar 29th, 2005 |
|---|---|
| Device trade name | PALAMED® G |
| Common Name | PMMA Bone Cement |
| Classification name | Bone Cement, 888.3027 |
| Identification of the marketed device to which equivalence is claimed | PALACOS® R BONE CEMENTPMA Number: P810020 |
| Description of the device | PALAMED® G 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. |
| Intended use | 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. |
| Comparison of technological characteristics | Palamed® G is similar to Palacos R except for the additional gentamicin sulphate and a lower initial viscosity. Palamed® G performs very similar to Palacos R.See also K030904 (PALAMED). |
| Submitted by | Dr. C. Tuchschererphone: +49 6081 959-278fax: +49 6081 959-252christian.tuchscherer@heraeus.com |
| Signature | Image: SignatureDate |
Image /page/0/Picture/7 description: The image shows the logo for Heraeus Kulzer. The logo is in black and white and features the company's name in a bold, sans-serif font. The name is split into two lines, with "Heraeus" on the top line and "Kulzer" on the bottom line. The logo is set against a black background.
CC02
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Dr. Christian Tuchscherer Heraeus Kulzer GmbH Grüner Weg 11 Germany - D-63450 Hanau
Re: K050855 Trade/Device Name: Palamed® G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: March 29, 2005 Received: April 4, 2005
Dear Dr. Tuchscherer:
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.
{2}------------------------------------------------
Page 2 - Dr. Tuchscherer
This letter will allow you to begin marketing your device as described in your Section 510(k) 1 mo letter will and the FDA finding of substantial equivalence of your device to a legally p whather 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 (240) 276-0120 . 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hipt Rluder
iriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: PALAMED® G
Indications For Use:
PALAMED® G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Prescription Use yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use no (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stypa Plurdin
Page 1 of 1 -
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOSO855 510(k) Number_
§ 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.”