(30 days)
Total knee replacement is indicated for patients suffering from severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, or pseudogout. These devices are intended for cemented use only.
Stemmed tibial baseplate components are part of the MG II Total Knee System. They incorporate a central stem with available modular stem extensions. There are three versions of stemmed tibial baseplate components: Porous, PMMA Precoat, and Option (non-coated). They are available in the same size range, and are compatible with the same articular surface components, as the predicate device.
The provided document is a 510(k) summary for a medical device (MG II™ Total Knee System Stemmed Tibial Baseplate Components) and a clearance letter. This type of regulatory submission for orthopedic implants differs significantly from the type of information you'd find for AI/ML-based medical devices.
Therefore, the document does not contain any of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for an AI/ML algorithm.
Instead, it's a submission for a physical orthopedic implant and focuses on demonstrating substantial equivalence to a predicate device based on design modifications and non-clinical performance (mechanical testing).
Here's why the requested information isn't present:
- No AI/ML Component: The device is a knee prosthesis, not an AI/ML diagnostic or predictive tool.
- Regulatory Pathway: The 510(k) pathway for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing and comparison of materials, design, and intended use, rather than clinical efficacy studies involving human readers or AI performance metrics.
- "Performance Data (Nonclinical and/or Clinical)" Section: The document explicitly states:
- "Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device." This refers to mechanical or material testing, not AI performance.
- "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This confirms no clinical studies were performed, which would be essential for AI/ML device validation.
In summary, this document does not describe the acceptance criteria and study proving an AI/ML device meets those criteria because the device in question is a physical orthopedic implant, not an AI/ML system.
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Special 510(k): Device Modification
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| APR | 20 | 2005 |
|---|---|---|
| ----- | ---- | ------ |
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon HipsherSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | March 18, 2005 |
| Trade Name: | MG II™ Total Knee System Stemmed TibialBaseplate Components |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis21 CFR § 888.3560 |
| Predicate Device: | MG II Porous Total Knee System, manufactured byZimmer, Inc., K892800, cleared August 3, 1989 |
| Device Description: | Stemmed tibial baseplate components are part of theMG II Total Knee System. They incorporate acentral stem with available modular stemextensions. There are three versions of stemmedtibial baseplate components: Porous, PMMAPrecoat, and Option (non-coated). They areavailable in the same size range, and are compatiblewith the same articular surface components, as thepredicate device. |
| Intended Use: | Total knee replacement is indicated for patientssuffering from severe knee pain and disability dueto rheumatoid arthritis, osteoarthritis, primary andsecondary traumatic arthritis, polyarthritis, collagendisorders, avascular necrosis of the femoralcondyle, or pseudogout. |
| These devices are intended for cemented use only. |
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Comparison to Predicate Device:
Except for minor modifications, MG II Stemmed Tibial Baseplate Components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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APR 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K050723
K050723
Trade/Device Name: MG IJ™ Total Knee System Stemmed Tibial Baseplate Components Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Codes: JWH Dated: March 18, 2005 Received: March 21, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosed. 976, the enactment date of the Medical Device Amendments, or to conninered province that have been reclance with the provisions of the Federal Food, Drug, devices mat have been recuire a require approval of a premarket approval application (PMA). allu Cosmetic Ac, (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mainer of the Act include requirements for annual registration, listing of general condois provisions 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 IT your device is classified (600 as 310) of on the major regulations affecting your device can may be subject to subli duditions, 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 I least of advised that I Drivisounces at your device complies with other requirements of the Act that I DA has made a availations administered by other Federal agencies. You must of any I cacal statutes and regalabents and limited to: registration and listing (21 Comply with an the Her STequirements)01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bycrents (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manceling your and equivalence of your device to a legally premaired notincation: The PPA intelligence 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 If you desire specific advice for your access in the regulation of the regulation entitled, contact the Office of Compilance an (21 ) = (21CFR Part 807.97). You may obtain Misolanding by reference to promanteensbilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, international and Octass http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stepto Rhodes
Miriam Provost, Ph.D.
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:
MG II" Total Knee System Stemmed Tibial Baseplate Components
Indications for Use:
Total knee replacement is indicated for patients suffering from severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, or pseudogout.
These devices are intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
.
్రాల్య
AND/OR
Over-The-Counter Use (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)
Stypt Rurds
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.