RT-PLUS PE INSERT CLAMP by PLUS ORTHOPEDICS

The RT-PLUS™ Knee System is a tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use as a replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The RT-PLUS™ Modular Cemented Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL and the iliotibial band.

Device Description

The RT-PLUS™ Knee System is a tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. The snapping mechanism of the PE tibial inserts for the RT-PLUS™ Device Knee System (S/E May 11, 2001 - K003504) has been modified by adding a clamp to secure the PE insert to the tibial component. All PE tibial inserts of the predicate device have been modified, and they are available in sizes 2, 4, 6, 8 and 10, and each size in 8 mm, 11 mm, 14 mm and 17 mm height.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document describes a 510(k) submission for a modified medical device, the "RT-PLUS™ Knee System" (specifically, a modification to the PE tibial inserts). The core of the submission is to demonstrate substantial equivalence to a predicate device (K003504).

Here's what the document does state regarding performance:

Performance Data:

Type of Study: Biomechanical tests were performed.
Results: "The test results of the modified components were superior to the predicate device and are sufficient for in vivo loading."

However, the document lacks the following information that you requested:

A table of acceptance criteria and the reported device performance: While it states the modified device was "superior" and "sufficient," it doesn't provide specific numerical criteria or performance metrics.
Sample size used for the test set and the data provenance: No details on the number of samples tested or where the biomechanical test data originated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was a biomechanical test, not an expert-driven diagnostic study.
Adjudication method: Not applicable for biomechanical testing.
Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned. No information on human readers or AI assistance.
Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, as this is a physical prosthetic device, not an algorithm.
The type of ground truth used: Not explicitly stated beyond "biomechanical tests."
The sample size for the training set: Not applicable, as there is no mention of a training set or an AI algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a 510(k) summary for a physical medical device modification and focuses on demonstrating substantial equivalence through biomechanical testing, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.

Summary

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KO21714

510(k) Summary of Safety and Effectiveness

[in accordance with SMDA of 1990, 21 CFR 807.92(c)]

Contact:	PLUS ORTHOPEDICS
	6055 Lusk Blvd.
	San Diego, CA 92121
	Tel: 858-550-3800 x 2506
	Attn: Mr. Hartmut Loch, RAC
	Director, Regulatory Affairs

Trade name: RT-PLUS™ Knee System
Hinged Knee Prosthesis Common name:

Classification Prosthesis Knee, Femorotibial, Constrained, Cemented, Metal/Polymer § 888.3510 - Class II - Product Code: KRO - 87 Orthopedic Device Panel name:

Predicate Device: RT-PLUS™ Knee System, K003504 - S/E 5/11/01

The snapping mechanism of the PE tibial inserts for the RT-PLUS™ Device Knee System (S/E May 11, 2001 - K003504) has been modified by Modification Description: adding a clamp to secure the PE insert to the tibial component. All PE tibial inserts of the predicate device have been modified, and they are available in sizes 2, 4, 6, 8 and 10, and each size in 8 mm, 11 mm, 14 mm and 17 mm height.

Indications: The RT-PLUS™ Knee System is a tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use as a replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The RT-PLUS™ Modular Cemented Knee provides joint stability when any or all of the following structures are nonfunctional: MCL, LCL, PCL, ACL and the iliotibial band.
Contraindications: Contraindications include acute or chronic infections (local or systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease. which might interfere with the function of the implant.

Performance Biomechanical tests have been performed. The test results of the data: modified components were superior to the predicate device and are sufficient for in vivo loading.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a row, with a flowing design element below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2002

Mr. Hartmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, CA 92121-2700

Re: K021714

Trade/Device Name: RT-PLUSTM Knee System Regulation Number: 21 CFR §888.3510 Regulation Name: Knee joint femortibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: May 21, 2002 Received: May 23, 2002

Dear Mr. Loch;

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.

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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.

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark A. Milken

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

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SPECIAL 510(K) DEVICE MODIFICATION RT-PLUS™ PE Insert Clamp May 21, 2002

Page 1 of of 1

K021714 510(k) Number:

RT-PLUS™ PE Insert Clamp Device Name(s):

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional format 1-2-96)

for Mark A. Milliken

ivision of General, Restorative nd Neurological Devices

510(k) Number K021714

Regulation Number and Section

N/A