(105 days)
The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.
The VKS Knee System is a tri-compartmental total knee prosthesis comprised of femoral, patellar and tibial components with an intrinsic tibial PE-insert. Standard, and Ultra-Congruent tibial components are available.
The provided document for the VKS Knee System (K022204) is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. It is important to note that a 510(k) submission for this type of device (a knee joint prosthesis) primarily relies on biomechanical testing and generally does not include clinical performance studies involving human subjects in the same way that software or AI/ML-based medical devices do.
Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of traditional medical device submission.
Here's the information based on the provided document:
Acceptance Criteria and Device Performance
The document states: "Performance data: Biomechanical Testing has been provided. All test results are sufficient for in vivo loading." This implies that the acceptance criteria were met through mechanical testing demonstrating the device's ability to withstand forces anticipated in the human body.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biomechanical Performance | "All test results are sufficient for in vivo loading." |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Biomechanical Testing." The document does not provide specific details about the methodology, results, or comparison to acceptance criteria thresholds, but it asserts that this testing was sufficient.
Additional Information (based on the provided document):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. Biomechanical testing typically involves physical samples of the device, not human data.
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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/Not provided. Ground truth for biomechanical testing is typically established by engineering specifications and industry standards, not expert medical consensus on human data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This concept applies to human reader studies, not biomechanical testing.
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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. An MRMC comparative effectiveness study was not done. This is not relevant for a knee prosthesis submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biomechanical testing, the "ground truth" would be engineering specifications and established standards for mechanical properties and durability, rather than medical ground truth from patient data.
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The sample size for the training set:
- Not applicable/Not provided. This type of device does not involve a training set as used in AI/ML.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
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OCT 1 8 2002
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
PLUS ORTHOPEDICS Contact: 6055 Lusk Blvd. San Diego, CA 92121
- VKS Knee System Trade name:
Common name: Knee Joint Prosthesis
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Classification name: Polymer/Metal/Polymer. & 21 CFR 888.3560, Class II, 87 JWH
TC-PLUS™ Solution Knee System (K000666, SE date 10/13/2000) Equivalence:
The VKS Knee System is a tri-compartmental total knee prosthesis Characteristics: comprised of femoral, patellar and tibial components with an intrinsic tibial PE-insert. Standard, and Ultra-Congruent tibial components are available.
- The VKS Knee System is intended as a cemented surface replacement Indications: in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.
- Contraindications include acute or chronic infections (local or systemic) Contraindications: or a history of infection; severe muscular, neurological, or vascular deficiencies which compromise the affected extremity: bone defects or insufficient bone quality which may affect the stability of the implant; any concomitant illness which may compromise the function of the implant; severe obesity; allergy to the implant materials; subluxation of the femur against the eminentia; ligament instability; severe varus or valgus misalignment; retropatellar degenerative arthritis; extension contractures over 10°.
- Performance data: Biomechanical Testing has been provided. All test results are sufficient for in vivo loading.
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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & 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 two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca Wahl Consultant, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121
Received: October 4, 2002
Re: K022204
Trade/Device Name: VKS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: October 3, 2002
Dear Ms. Wahl:
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
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Page 2 - Ms. Rebecca Wahl
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.
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
l Mark N. Milliken
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 .
510(k) Number: K022204
Device Name(s):
VKS KNEE SYSTEM
Indications for Use:
The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022204 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter-Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (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.