(259 days)
- Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
- Failure of a previously failed joint replacement procedure 2.
- Correction of varus, valgus or post-traumatic deformity 3.
- Correction or revision of unsuccessful osteotomy or arthrodesis 4 .
The device is intended for use with bone cement (USA)
The AGC V2 Revision Knee System is an extension of Biomet's knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 system employs Biomet's standard all polyethylene patella button.
Unique features of the AGC V2 System included the femoral stem angle being built into the stem itself rather than the boss of the femoral component like other systems. The device expands Biomet's existing AGC product line by providing a device with more constraint than current components and additional augments for the femoral component.
The AGC V2 tibial component provides a one-piece molded component with a high post posterior stabilized option. Pegs on the bottom of the tray provide stability for the augmentations.
This document focuses on the substantial equivalence of the AGC V2 Revision Knee System to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance data. The FDA 510(k) approval process for devices like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on new clinical performance studies with predefined acceptance criteria.
Therefore, many of the requested elements for a detailed study description are not available in the provided text.
Based on the provided text, here's what can be inferred:
1. Table of acceptance criteria and reported device performance:
This information is not provided in the document. The document primarily focuses on establishing "substantial equivalence" to predicate devices, not on presenting specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
This information is not provided. The document does not describe a "test set" in the context of a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to this type of submission.
4. Adjudication method for the test set:
This information is not provided.
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a knee implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm-only performance study was not done. This device is a physical knee implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as it relates to evaluating an algorithm's performance is not applicable here. Instead, the "truth" for this regulatory submission is the established safety and effectiveness of the predicate devices to which the AGC V2 Revision Knee System is compared.
8. The sample size for the training set:
This information is not provided. There is no mention of a "training set" in the context of a machine learning model.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for a machine learning model.
Summary regarding acceptance criteria and studies:
The provided K984054 document is a 510(k) premarket notification for a medical device (AGC V2 Revision Knee System). The core of a 510(k) submission is to demonstrate substantial equivalence to a device already legally marketed in the U.S. (a predicate device). This process typically involves:
- Comparison of technological characteristics: Showing that the new device has similar design, materials, and operational principles to the predicate.
- Discussion of intended use: Confirming the new device's indications for use are the same as or comparable to the predicate.
- Performance data (often non-clinical): This might include bench testing, mechanical testing, or material characterization to show that the device performs as intended and is as safe and effective as the predicate. In this case, the document states, "In function and overall design, Biomet's AGC V2 Revision Knee System is equivalent to almost all knee components on the market."
The document lists several Biomet knee systems as comparators (predicate devices):
- AGC 2000 Total Knee Prosthesis (K833921)
- AGC Revision Knee Prosthesis (K912245)
- MCK (Maxim) Knee System (K915132)
The "study" in this context is the comparison to these predicate devices to establish substantial equivalence. Specific quantitative acceptance criteria for clinical performance are generally not a requirement for this type of 510(k) pathway, as the safety and effectiveness are established by reference to the predicate.
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Image /page/0/Picture/2 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a stylized font. Below the logo, the words "Corporate Headquarters" are written in a smaller font.
Summary of Safety and Effectiveness
Biomet. Inc. Sponsor: Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: AGC V2 Revision Knee System
Classification Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis (CFR 888.3560)
Indications:
- Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
-
- Failure of a previously failed joint replacement procedure
-
- Correction of varus, valgus or post-traumatic deformity
-
- Correction or revision of unsuccessful osteotomy or arthrodesis
The device is intended for use with bone cement (USA)
Device Description: The AGC V2 Revision Knee System is an extension of Biomet's knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 system employs Biomet's standard all polyethylene patella button.
Unique features of the AGC V2 System included the femoral stem angle being built into the stem itself rather than the boss of the femoral component like other systems. The device expands Biomet's existing AGC product line by providing a device with more constraint than current components and additional augments for the femoral component.
The AGC V2 tibial component provides a one-piece molded component with a high post posterior stabilized option. Pegs on the bottom of the tray provide stability for the augmentations.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Nerve damage
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Disassociation of components Bone fracture Infection Hematoma Dislocation Excessive wear
Substantial Equivalence: In function and overall design, Biomet's AGC V2 Revision Knee System is equivalent to almost all knee components on the market. These systems include:
AGC 2000 Total Knee Prosthesis (Biomet, Inc., Warsaw, IN) AGC Revision Knee Prosthesis (Biomet, Inc., Warsaw, IN) MCK (Maxim) Knee System (Biomet, Inc., Warsaw, IN)
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
OFFICE 219.267.6639
FAX 219.267.8137
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 or bird design with three curved lines representing its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet INC Airport Industry Park P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K984054
Trade Name: AGC V2 Revision Knee System Regulatory Class: II Product Code: JWH Dated: May 6, 1999 Received: May 7, 1999
Dear Ms. Sandborn Beres:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K984054
Device Name: AGC V2 Revision Knee System
Indications For Use:
- Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
- Failure of a previously failed joint replacement procedure 2.
- Correction of varus, valgus or post-traumatic deformity 3.
- Correction or revision of unsuccessful`osteotomy or arthrodesis 4 .
ﺮ
The device is intended for use with bone cement (USA)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Acòde
(Division Sign-Off)
Division of General Restorative Devices K984054
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.