(94 days)
PALACOS® LV + 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.
Palacos® LV + 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.
The provided text is a 510(k) summary for PALACOS® LV + G bone cement. This document does not describe a study involving an algorithm or device performance in the context of diagnostic accuracy, image analysis, or similar applications where acceptance criteria and performance are typically measured with metrics like sensitivity, specificity, or AUC.
Instead, this 510(k) focuses on demonstrating substantial equivalence to a legally marketed predicate device (OSTEOPAL® K030903 and PMA P810020) for a medical device (bone cement). The primary "acceptance criteria" here is substantial equivalence to the predicate, with the main difference being the addition of gentamicin.
Therefore, many of the requested elements for describing an AI/algorithm study (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, how ground truth for training was established) are not applicable to this type of regulatory submission.
However, I can extract the relevant information from the provided text regarding the device and its claimed equivalence.
Here's an interpretation of the request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) of a bone cement, "acceptance criteria" typically refer to demonstrating that the new device is as safe and effective as a predicate device. This is often done by comparing technological characteristics and, if applicable, performance in terms of mechanical properties or elution rates for antibiotic-loaded cement.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence for bone cement) | Reported Device Performance/Characteristics |
|---|---|
| Intended Use Equivalence | Indicated for use in the second stage of a two-stage revision for total joint arthroplasty after initial infection has been cleared. (Matches predicate's context, adjusted for antibiotic presence implied). |
| Technological Characteristics Equivalence (Composition, properties) | Acrylic bone cement (PMMA). Formed from powder and liquid by exothermic polymerization. Includes Gentamicin (difference to primary predicate OSTEOPAL). Performance "most similar to Osteopal." |
| Safety and Effectiveness Equivalence | Implied through substantial equivalence claim to OSTEOPAL® K030903 and PMA P810020. No specific performance metrics (e.g., mechanical strength) are listed in this summary, but would have been part of the full submission. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This summary does not describe a clinical study with a "test set" in the context of an algorithm's performance. The review is based on a comparison of the device's characteristics to a predicate.
- Data Provenance: Not applicable. The submission is from Heraeus Kulzer GmbH, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study assessing diagnostic accuracy or expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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 device is bone cement, not an AI or imaging diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for this type of device and submission. The "ground truth" for the 510(k) process is the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
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510(k)
Palacos LV®+ G
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510(k) Summary
| Mar 29th, 2005 | |
|---|---|
| Date of summary | |
| Device trade name | PALACOS® LV + G |
| Common Name | PMMA Bone Cement |
| Classification name | Bone Cement, 888.3027 |
| Identification of the marketed device to whichequivalence is claimed | OSTEOPAL® K030903PMA P810020 1998 |
| Description of the device | Palacos® LV + G is an acrylic bone cement for usein orthopedic surgery. It is formed from powderand liquid by exothermic polymerization. It securesthe fixation of the grafted artificial joint improvingthe transfer of forces at the interface implant -bone. |
| Intended use | The cement is indicated for use in the second stageof a two stage revision for total joint arthroplastyafter the initial infection has been cleared. |
| Comparison of technological characteristics | The only difference to Osteopal is the additionalgentamicin. The cement performs most similar toOsteopal. |
| Submitted by | Dr. C. Tuchschererphone: +49 6081 959-278fax: +49 6081 959-252christian.tuchscherer @heraeus.com |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUL 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Christian Tuchscherer Heraeus Kulzer GmbH Division Heraeus Medical Phillip Reis-Strasse 8/13 Wehrheim, Germany - D-61273
Re: K050854
Trade/Device Name: Palacos® LV + G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: March 30, 2005 Received: April 7, 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, iisting 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. Christian Tuchscherer
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 it you attent 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,
Hupt Rhodes
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: PALACOS® LV + G
Indications For Use:
PALACOS® LV + 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)
Styt Rlurlie
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(Division Sign-Off Division of General, Restorative. and Neurological Devices
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.”