(28 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.
Use the TC-PLUS patella with the VKS Knee System.
This is a 510(k) premarket notification for a medical device (VKS Knee System), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.
Therefore, many of the requested items related to study design, acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness are not available in the provided text. The document is an FDA approval letter and a summary of safety and effectiveness, which does not typically include a detailed performance study report.
Here's a breakdown of the information that can be extracted, and where information is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text as specific numerical thresholds for performance. The approval is based on "substantial equivalence" to a predicate device, meaning it performs similarly and is as safe and effective.
- Reported Device Performance: Not provided as specific performance metrics. The document states "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...". This implies that the performance was deemed acceptable relative to the predicate, but specific performance values are not given.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical performance targets. The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device regarding safety and effectiveness. | The device was determined to be "substantially equivalent" to the predicate devices (TC-Plus Knee System, K000666/VKS Knee System K022204) for its stated indications for use. Specific performance metrics are not detailed in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no specific clinical test set is described. The 510(k) process for a knee prosthesis typically relies on non-clinical testing (e.g., mechanical testing, materials characterization, and comparison to predicate) rather than a clinical "test set" in the context of an AI/imaging device.
3. 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 as no specific clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific clinical test set requiring adjudication is described.
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
- Not applicable. This is not an AI or imaging device. It is a knee joint prosthesis, and such studies are not relevant to its regulatory pathway.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no specific study involving "ground truth" (in the context of diagnosis or interpretation) is detailed. The "ground truth" for a prosthetic device would relate to its mechanical properties, biocompatibility, and clinical outcomes, which are typically assessed through non-clinical testing and long-term surveillance rather than a "ground truth" similar to image interpretation.
8. The sample size for the training set
- Not applicable. This is a medical device (knee prosthesis), not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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K023416
page 1 of 1
NOV 8 2002
510(k) Summary of Safety and Effectiveness
Contact:
PLUS ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121 Tel: 858-550-3800 x 2506
Trade name: VKS Knee System
Common name: Knee Joint Prosthesis
Classification Prosthesis, Knee Patellofemoratibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 888.3860, 87 JWH name:
Equivalence: TC-Plus Knee System, K000666/VKS Knee System K022204
Device Modification Use the TC-PLUS patella with the VKS Knee System. Description:
Indications:
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.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 NOV
Ms. Louise Focht Consultant PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121-2700
Re: K023416
Trade/Device Name: VKS 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 10, 2002 Received: October 11, 2002
Dear Ms. Focht:
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. Louise Focht
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 vours.
Sincerely yours,
Mark A. Millburn
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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SPECIAL 510(K) DEVICE MODIFICATION VKS Knee System October 10, 2002
Page 1 - of
K023416 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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 | K023416 |
| Prescription Use | 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.