VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision k nee a rthroplasty w here the collateral ligaments a re intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, or connective tissue disorders. It is for cemented use only.

Device Description

The VKS/TC-PLUS Revision Knee is a tri-compartmental knee consisting of a femoral component, tibial baseplate, tibial insert, femoral and tibial augmentation blocks and intramedullary stems.

The VKS/TC-PLUS Revision femoral component is available in five size and right and left configurations. It has a post in the box into which is machined a female Morse type taper to receive an intramedullary stem. It is also configured to received posterior and distal augmentation blocks.

The VKS/TC-PLUS Revision tibial baseplate has five sizes, right and left, and has the same outer profile as the VKS baseplates cleared in K022204. The tibial insert locking mechanism is the VKS Knee. The inferior surface of the baseplate has a short post with a female type taper machined into it to receive modular stems and a hole through the baseplate to receive a screw to augment the baseplate/stem connection. The stems are as used on the femoral component. The inferior surface of the baseplate also has two fins that extend posterior/laterally from the post.

The same ultra-congruent insert cleared with the VKS Knee under K022204 is used with the VKS/TC-PLUS Revision Knee.

The femoral augmentation blocks are available in distal and posterior configurations, 5mm and 10mm thickness. The tibial augmentation blocks are available in half blocks so that medial, lateral or full augmentation can be achieved. They are also available in 5mm and 10mm thickness.

AI/ML Overview

This document describes a premarket notification (510(k)) for the VKS/TC-PLUS Revision Knee, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with acceptance criteria, ground truth, and statistical analysis typically associated with AI/software devices. Therefore, many of the requested categories related to such studies are not applicable.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Details for K032215

As this is a 510(k) submission for a physical medical device (a knee prosthesis), the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/software device's performance metrics (like sensitivity, specificity, etc.) is not directly applicable. For this device, acceptance criteria are generally met through substantial equivalence to predicate devices in terms of materials, design, intended use, and engineering analysis demonstrating comparable strength.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this type of device are primarily tied to demonstrating equivalence to predicate devices and meeting established engineering standards and safety requirements. Performance is assessed through engineering analysis and comparison.

Acceptance Criteria Category (for 510(k) devices)	Reported Device Performance (from K032215)
Substantial Equivalence to Predicate(s)	The VKS/TC-PLUS Revision Knee is equivalent to the VKS Total Knee (K022204) in terms of materials, articulating surface geometry, constraint, and indications. It is also equivalent to the RT-PLUS Modular Knee (K023667) in terms of modular stems and augmentation blocks.
Materials	Equivalent to predicate devices (K022204 and K023667).
Articulating Surface Geometry	Equivalent to VKS Total Knee (K022204). The same ultra-congruent insert cleared with the VKS Knee under K022204 is used.
Constraint	Equivalent to VKS Total Knee (K022204).
Indications for Use	Stated indications are for revision knee arthroplasty where collateral ligaments are intact, and it's not indicated for significant bone loss/ligamentous deficiencies due to specific pathologies. Note: K032215 initially stated a broader indication ("where the collateral ligaments are indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tuma, infection, or connective tissue disorders") but the final Indications for Use statement (Page 3) clarifies it is for intact collateral ligaments and not indicated for significant bone loss/ligamentous deficiencies. This discrepancy was likely clarified during the review process.
Mechanical Strength/Integrity	"Engineering analysis indicates that the VKS/TC-PLUS Revision Knee is as strong as its predicate devices."
Manufacturing Processes	Presumed to comply with good manufacturing practice (GMP) requirements (implied by FDA's general controls statement).

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as this is a 510(k) for a physical implantable device, not an AI/software device requiring a test set of data. The "test" for this device is primarily via engineering analysis and comparison to predicate devices, not clinical data from a prospective or retrospective study on patients for algorithm performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies evaluating diagnostic or prognostic AI/software. For a knee prosthesis 510(k), experts (e.g., orthopedic surgeons, materials scientists, mechanical engineers) would be involved in the design, testing, and regulatory review, but not in establishing "ground truth" for a test set in the way you're asking.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as (2) and (3). There is no "test set" in the context of an AI/software device study.

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

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in imaging or diagnostic tasks. This device is a surgical implant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. This device is a physical knee prosthesis and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable in the context of AI/software performance. For a knee prosthesis, "ground truth" might refer to validated biomechanical models, material property standards, or clinical outcomes from predicate devices, but not in the way it's used for AI validation.

8. The Sample Various Size for the Training Set

This information is not applicable. There is no "training set" for this type of device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no "training set" or "ground truth" that would be established in this manner for this device.

Summary

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K032215

Date July 17, 2003

Submitter PLUS Orthopedics 6055 Lusk Blvd San Diego, CA

AUG - 8 2003

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name Total knee

Classification name

Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (per 21 CFR section 888.3560)

Equivalent Device

The VKS/TC-PLUS Revision Knee is equivalent to the VKS Total Knee (K022204) in terms of materials, articulating surface geometry, constraint and indications, and the RT-PLUS Modular Knee (K023667) in terms of modular stems and augmentation blocks.

Device Description

The VKS/TC-PLUS Revision Knee is a tri-compartmental knee consisting of a femoral component, tibial baseplate, tibial insert, femoral and tibial augmentation blocks and intramedullary stems.

The same ultra-congruent insert cleared with the VKS Knee under K022204 is used with the VKS/TC-PLUS Revision Knee.

Intended Use

The VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision knee arthroplasty where the collateral ligaments are indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tuma, infection, or connective tissue disorders. It is for cemented use only.

Summary of Technological Characteristics Compared to Predicate Device

Engineering analysis indicates that the VKS/TC-PLUS Revision Knee is as strong as its predicate devices.

Bay | of |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol consisting of three stylized human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

PLUS Orthopedics c/o Mr. J.D. Webb Authorized Contact Person 1001 Oakwood Blvd Round Rock, TX 78681

Re: K032215

Trade/Device Name: VKS/TC-PLUS Revision Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: July 17, 2003 Received: July 21, 2003

Dear Mr. Webb:

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 - Mr. J.D. Webb

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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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510(k) number (if known):

K032215

Device Name: VKS/TC-PLUS Revision Knee

Indications for Use:

VKS/TC-PLUS Revision Knee Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of General, Neurological and Restorative Devices

510(k) Number

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_KO322215

Page iii

Regulation Number and Section

§ 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.