(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 use with bone cement.
Vanguard™ Removable Molded Polyethylene Tibia is intended to replace the tibial articulating surface in a joint replacement along with femoral components that were cleared in K023546. There are three parts to the Vanguard™ Removable Molded Polyethylene Tibia component: the tibial tray, tibial bearing, and an insert.
The I-beam profile of the tibial tray is identical to that of the Maxim® tibial tray cleared in the following submissions K984623 and K991753. The articulating surface is identical to the surface cleared in K023546.
The provided document is a 510(k) summary for a medical device called the "Vanguard™ Removable Molded Polyethylene Tibia (Pop-Top)". This type of document is for premarket notification of a medical device and aims to demonstrate substantial equivalence to a predicate device already on the market. It does not typically include detailed studies with acceptance criteria, sample sizes, expert-established ground truth, or multi-reader multi-case studies as would be found in a clinical trial report for AI/CAD devices.
Based on the provided text, here's what can be extracted and what is explicitly stated as not applicable:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or a direct performance table as would be expected for an AI/CAD device. Instead, the "acceptance" is based on demonstrating substantial equivalence through non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional within intended use | "The results indicated that the device was functional within its intended use." |
| Similar to predicate devices in technological characteristics | "The technological characteristics (direct molding UHMWPE onto the tibial tray and the Vanguard™ articulating surface) of the Vanguard™ Removable Molded Polyethylene Tibia are similar to or identical to the predicate devices." |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set for clinical performance is mentioned. The assessment was based on non-clinical laboratory testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No clinical ground truth was established from experts for a device performance test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication process is described.
-
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. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This type of study is not relevant for this device's submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implantable device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would be established by engineering standards and specifications for material properties, mechanical performance, and design adherence to the predicate device. The document does not detail the specific ground truth methods for these non-clinical tests, but implies they were sufficient for substantial equivalence.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
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Image /page/0/Picture/0 description: The image shows the word BIOMET in a bold, sans-serif font. Each letter is outlined with a thick black border, giving the text a blocky appearance. The letters are tightly spaced, creating a compact and solid visual unit.
Ka60525
510(k) Summary
Preparation Date: 24 February 2006
MAY 2 5 2006
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Tracy Bickel Johnson, RAC
Proprietary Name: Vanquard™ Removable Molded Polyethylene Tibia (Pop-Top)
Common Name: knee prostheses
Classification Name: JWH- prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (888.3560)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Removable Molded Polyethylene Tibia (Pop-Top) - K991753 and K984623 (Biomet, Inc.): Vanquard™ System- K023546 (Biomet, Inc.)
Device Description: Vanguard™ Removable Molded Polyethylene Tibia is intended to replace the tibial articulating surface in a joint replacement along with femoral components that were cleared in K023546. There are three parts to the Vanguard™ Removable Molded Polyethylene Tibia component: the tibial tray, tibial bearing, and an insert.
The I-beam profile of the tibial tray is identical to that of the Maxim® tibial tray cleared in the following submissions K984623 and K991753. The articulating surface is identical to the surface cleared in K023546.
Intended Use:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic 1. arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity. 2.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint 3. replacement procedure.
The device is a single use implant intended for use with bone cement.
Summary of Technologies: The technological characteristics (direct molding UHMWPE onto the tibial tray and the Vanguard™ articulating surface) of the Vanguard™ Removable Molded Polyethylene Tibia are similar to or identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
MAILING ADDRESS 1:0. Box 587 Warsaw, IN 46581 0587 - - - -
SHIPPING ADDRESS 56 E. Bell Drive Warsow, IN 46582
.
()Ff-1Ct; 574. 267.6659
I'AX 574.267 81.47
E-MAH. biomet@hiomet.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
Biomet Manufacturing Corp c/o Mr. Tracy Bickel Johnson 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581
Re: K060525
Trade/Device Name: Vanguard Removable Molded Polyethylene Tibia Regulation Number: CFR 888.3560 . Regulation Name: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Regulatory Class: Class II Product Code: JWH Dated: February 24, 2006
Received: February 27, 2006
Dear Mr. Johnson:
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
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Page 2 -- Mr. Tracy Bickel Johnson
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. 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 (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.
Hebert Lerner mo
Mark N. Melkerson 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: Vanguard™ Removable Molded Poly Tibia
Indications For Use:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 1. traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity. 2.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous 3. joint replacement procedure.
The device is a single use implant intended for use with bone cement.
Prescription Use × (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)
Herbert Simmering
sion Sign-Off Division of General. Restorative. and Neurological Devices
510(k) Number K060525
Page 1 of 1
§ 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.