(90 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 total joint replacement procedure.
The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It consists of femoral components composed of cast Co-Cr-Mo per ASTM F-75 with either a porous plasma spray (PPS) or Interlok® surface finish, tibial bearings molded of polyethylene (UHMWPE) conforming to ASTM F-648 or machined of polyethylene (UHMWPE or UHMWPE with a-tocopherol) conforming to ASTM F-648, tibial trays (not part of this submission) and patellar components machined of polvethylene (UHMWPE) conforming to ASTM F-648.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
Important Note: The provided document is a 510(k) summary for a Vanguard® Complete Knee System (Knee Prosthesis). For this type of medical device, the "acceptance criteria" and "study" described are primarily related to mechanical and physical testing to demonstrate substantial equivalence to previously cleared devices, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested fields regarding expert adjudication, effect size of human readers with AI assistance, and training set information are not applicable (N/A) in this context.
Acceptance Criteria and Study for the Vanguard® Complete Knee System
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Parameter | How Performance Was Measured/Reported | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Tibial-femoral Contact Area | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." |
| Patello-femoral Contact Area | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Patellofemoral Mechanical Stability | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Tibialfemoral Constraint | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Tibialfemoral Mechanical Stability | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Posterior Stabilized Fatigue | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Posterior Stabilized Static Load | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Range of Motion Analysis | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| 80/20 Femoral Fatigue | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Vanguard® PS Open Box Tensile Stress | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Constraint testing of AS and CR-L | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Contact Area Analysis (AS bearing) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Static Rotational Strength Test (PS+) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Varus/Valgus Constraint (PS+) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Tensile Strength E-poly | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Wear Testing E-poly | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Contact Areas Analysis (patellar) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Overall Conclusion | Substantial equivalence to predicate knee systems | Evaluation of technological characteristics and safety/efficacy implications of modifications. | "The Vanguard® Complete Knee System is substantially equivalent to previously cleared Biomet knee systems and do not raise any new issues of safety or efficacy." |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a number of "samples" in a clinical sense. The "test set" here refers to the collection of mechanical tests performed on the device components.
- Data Provenance: The tests were "previously performed" and the "test reports were provided in the predicate 510(k)s," suggesting that new, independent tests specifically for this submission were not all conducted, but rather existing data from predicate devices or previous versions demonstrating the performance of similar components. The tests themselves are non-clinical, laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. For mechanical testing, "ground truth" is typically established by engineering specifications, accepted industry standards (e.g., ASTM F-75, F-648), and internal quality control criteria, rather than expert human consensus in the way it's used for AI/diagnostic devices. The "experts" would be the engineers and technicians performing and verifying the tests against these established standards.
4. Adjudication method for the test set
- N/A. Given this is mechanical testing against defined specifications, there is no direct "adjudication method" involving multiple human readers as would be found in clinical imaging studies. The results are quantitative measurements compared against predefined pass/fail criteria.
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. This is a mechanical device, not an AI/software diagnostic device. An MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
7. The type of ground truth used
- Engineering Specifications and Industry Standards: The ground truth for this device's performance is based on established engineering specifications, mechanical test standards (e.g., ASTM F-75, F-648), and internal acceptance criteria developed to ensure the safety and efficacy of knee prostheses. The goal is to demonstrate that the device performs within these acceptable mechanical limits.
8. The sample size for the training set
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set.
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FEB 2 9 2012
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Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with thick, blocky letters. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black on a white background.
510(k) Summary
| Preparation Date: | 28 November, 2011 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0857Establishment Registration No. 1825034 |
| Contact Person: | Gary Baker, MS RACSenior Regulatory Affairs SpecialistBiomet Manufacturing Corp.56 East Bell DriveWarsaw, Indiana 46580Phone: (574) 371-6639Fax: (574) 371-1027gary.baker@biomet.com |
| Proprietary Name: | Vanguard® Complete Knee System |
| Common Name: | Knee Prosthesis |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous- coateduncemented prosthesis (21CFR §888.3565) |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis (21CFR §888.3560) |
| Classification Name: | Knee joint patellofemorotibial polymer+Additive/metal/polymer+Additivesemi-constrained cemented prosthesis (21CFR §888.3560) |
| Legally Marketed Devices To Which Substantial Equivalence Is Claimed: | K023546 Vanguard® CR Knee SystemK033489 Vanguard® CR Knee SystemK041046 Vanguard® PS+ BearingsK050222 Vanguard® AS Tibial BearingsK060303 Vanguard® PS Open Box Porous FemoralK061340 Vanguard® Single Peg PatellaK080528 E1® Tibial Components (previously E-poly) |
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Device Description: The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It consists of femoral components composed of cast Co-Cr-Mo per ASTM F-75 with either a porous plasma spray (PPS) or Interlok® surface finish, tibial bearings molded of polyethylene (UHMWPE) conforming to ASTM F-648 or machined of polyethylene (UHMWPE or UHMWPE with a-tocopherol) conforming to ASTM F-648, tibial trays (not part of this submission) and patellar components machined of polvethylene (UHMWPE) conforming to ASTM F-648.
Intended Use: Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (interlok") devices and all polyethylene patellar components are indicated for cemented application only.
Summary of Technologies: The Vanguard® Complete Knee System components have the same technological characteristics as the predicate components with the exception of the modifications described within this 510(k). Non-clinical testing was conducted to demonstrate that the modifications did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components.
Non-Clinical Testing: Mechanical testing was previously performed to determine substantial equivalence. All testing met or exceeded the established acceptance criteria. The following test reports were provided in the predicate 510(k)s.
Tibial-femoral Contact Area, Patello-femoral Contact Area. Patellofemoral Mechanical Stability, Tibialfemoral Constraint, Tibialfemoral Mechanical Stability, Posterior Stabilized Fatigue, Posterior Stabilized Static Load, Range of Motion Analysis. 80/20 Femoral Fatigue, Vanguard® PS Open Box Tensile Stress, Constraint testing of AS and CR-L, Contact Area Analysis (AS bearing), Static Rotational Strength Test (PS+), Varus/Valgus Constraint (PS+), Tensile Strength E-poly, Wear Testing E-poly, and Contact Areas Analysis (patellar)
Clinical Testing: Clinical data is not necessary for a determination of substantial equivalence.
Conclusion: The Vanguard® Complete Knee System is substantially equivalent to previously cleared Biomet knee systems and do not raise any new issues of safety or efficacy.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a double-stranded snake winding around a staff.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Mr. Gary Baker, MS RAC Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46580
FEB 2 9 2012
Re: K113550
Trade/Device Name: Vanguard Complete Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY . Dated: November 28, 2011 Received: December 1, 2011
Dear Mr. Baker:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Gary Baker
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erina Keith
Image /page/3/Picture/6 description: The image shows a stylized handwritten word, possibly "for". The "f" is written in a cursive style with a long, curved descender. The "o" is connected to the "f" and is also written in a cursive style. The "r" is connected to the "o" and is also written in a cursive style. The word is written in black ink on a white background.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
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Indications for Use
KIJSEED 510(k) Number (if known):
Device Name: Vanguard® Complete 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 total joint replacement procedure.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NQ (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)
K
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII 3 E CO 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.