(87 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is a single use implant intended for implantation with bone cement.
The Maxim Accel Knee System is intended to replace the articular portions of the knee joint. The system consists of three femoral components with augmentation pieces and three modular tibial bearings.
The provided text describes a 510(k) premarket notification for the "Maxim Accel Knee System." This document is a summary of safety and effectiveness, and it focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device or AI algorithm.
Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.
Here's a breakdown of why these elements are not present and what the document does provide:
- Acceptance Criteria and Reported Device Performance: This device is a traditional medical implant (knee replacement system). Its "performance" is primarily assessed through mechanical testing and comparison to predicate devices, not through performance metrics like accuracy, sensitivity, or specificity found in AI/diagnostic device studies. The document only states "All mechanical testing was done in accordance to 1994- Draft guidance for the preparation of Premarket Notifications (510(j)s) for cemented, semi-constrained total knee prostheses." This indicates compliance with established mechanical testing standards for knee prostheses, but no specific acceptance criteria or reported values are listed in this summary.
- Clinical Testing / Studies: The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means no human clinical studies were conducted or submitted for this 510(k) application to prove the device meets specific clinical performance criteria. The device's approval is based on its similarity to previously cleared devices.
- Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: All of these elements are typically associated with studies involving human data, particularly for diagnostic devices, AI algorithms, or comparative effectiveness studies, none of which were performed for this 510(k) submission.
In summary, the provided document is a regulatory submission for a physical medical implant (knee system) based on substantial equivalence, not a study evaluating an AI algorithm or diagnostic device with defined acceptance criteria and clinical performance metrics.
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0225546
BIOMET
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SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet Inc.Airport Industrial ParkP.O. Box 587Warsaw, IN 46581-0587JAN 17 2003 |
|---|---|
| Contact Person: | Tracy J. Bickel(574) 267-6639 |
| Device(s): | Maxim Accel Knee System |
| Classification Name: | Cemented semi-constrained polymer/metal/polymer (888.3560) |
| Device Classification: | Class II |
| Device Product Code: | 87 JWH |
| Substantially Equivalent Devices: | MCK (K915132); Performance (K936274) |
| Device Description: | The Maxim Accel Knee System is intended to replace the articular portions of the kneejoint. The system consists of three femoral components with augmentation pieces andthree modular tibial bearings. |
Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement 3) procedure.
The device is a single use implant intended for implantation with bone cement.
| Summary of Technologies: | The femoral component and tibial bearings have been redesigned.The Maxim Accel Knee System is similar to or identical in terms of function,labeling, and sizing to the predicate MCK device(s). |
|---|---|
| Non-Clinical Testing: | The Maxim Accel Knee System is intended to replace the articular portions of the kneejoint. The system consists of three femoral components with augmentation pieces andthree modular tibial bearings. All mechanical testing was done in accordance to 1994-Draft guidance for the preparation of Premarket Notifications (510(j)s) for cemented,semi-constrained total knee prostheses. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |
All trademarks are property of Biomet, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
트
000015
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
OFFICE 574.267.6639
FAX 574.267.8137
E-MAIL biomet@biomet.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Ms. Tracy Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0578
Re: K023546
Trade/Device Name: Maxim Accel Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: October 18, 2002 Received: October 22, 2002
Dear Ms. Bickel:
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 - Ms. Tracy Bickel
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
Celia 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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Page _ of _
510(k) Number (if known): Device Name: Maxim Accel Knee System Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is a single use implant intended for implantation with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milham
ivision Sign-Division of General, Restorative and Neurological Devi
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§ 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.