Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Profix Total Knee System includes porous coated devices which are indicated for use without bone cement, and are single use devices.

Device Description

The overall design, components, and materials of the Profix Total Knee System are substantially equivalent to the existing components of the Profix Total Knee System cleared under previous premarket notifications. The main difference between the subject components of the Profix Total Knee System, and the currently marketed components is the intended use of the system without bone cement.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the Smith & Nephew Profix Total Knee System, seeking clearance for devices indicated for use without bone cement. It is a submission to demonstrate substantial equivalence to previously cleared devices, not a study evaluating new performance criteria or clinical outcomes in the way requested by the prompt.

Therefore, most of the requested information cannot be extracted from the provided text because the submission is not a performance study as described in the prompt. Instead, it is a regulatory filing focused on demonstrating equivalence.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This submission is for substantial equivalence to existing devices, not a performance study with specific acceptance criteria and outcome metrics for patient care. The "performance" being evaluated here is the substantial equivalence to predicate devices, focusing on design, materials, and intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. This document does not describe a clinical performance study with a test set of patients or data provenance. It's a regulatory submission comparing device specifications.

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)

Cannot be provided. There is no "ground truth" derived from expert consensus in this type of submission. The ground truth for regulatory clearance in this context is the FDA's determination of substantial equivalence based on the provided documentation and comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set or expert 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

Cannot be provided. This is not an AI or diagnostic imaging device; it's a knee implant. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Cannot be provided. This is irrelevant to a knee implant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" (or basis for approval) for this submission is regulatory in nature. It relies on established predicate devices and the demonstration of "substantial equivalence" in terms of intended use, design, and materials. It's not a clinical performance ground truth based on patient outcomes, pathology, or expert consensus on diagnostic accuracy.

8. The sample size for the training set

Cannot be provided. This document does not describe a training set for an algorithm.

9. How the ground truth for the training set was established

Cannot be provided. This document does not describe a training set or its ground truth establishment.

Summary derived from the document:

The provided text describes a 510(k) Pre-Market Notification for the Smith & Nephew Profix Total Knee System. The purpose of this submission is to demonstrate that the expanded use of the system (without bone cement) is "substantially equivalent" to predicate devices already on the market.

Acceptance Criteria & Device Performance: The primary "acceptance criterion" in a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context is that the new components (indicated for use without bone cement) are substantially equivalent in terms of their intended use, designs, and materials to the existing Profix Total Knee System and other predicate total knee prostheses.
- Predicate Devices:
  - Profix Total Knee System (K933958)
  - Profix Posterior-Stabilized Knee System (K954909)
  - Profix Knee Posterior-Stabilized Plus Tibial Insert (K963255)
  - Tricon Knee System (K884824)
  - Freeman-Samuelson Mark II Press-Fit Total Knee Replacement (K853730)
Study Type: This is a substantial equivalence submission, not a clinical performance study involving patient data, expert review, or statistical analysis of outcomes for the new "uncemented" feature itself. The study conducted is a comparative technological assessment against predicate devices.

In essence, the document is a regulatory filing for a medical device approval based on equivalence, not a clinical study evaluating the device against specific performance metrics with patient data.

Summary

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510(K) SUMMARY SMITH & NEPHEW PROFIX TOTAL KNEE SY

AY 22 2003

SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME:

COMMON OR USUAL NAME: CLASSIFICATION NAME:

DEVICE CLASS: DEVICE PRODUCT CODE: PANEL CODE:

Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6707 Gino J. Rouss February 26, 2003 Smith & Nephew Profix Total Knee System Total Knee Prosthesis Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Class II MBH Orthopedics/87

DEVICE INFORMATION:

INTENDED USE: A.

The Profix Total Knee System is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
The posterior stabilized knee system is designed for use in patients in primary and 4. revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Profix Total knee system includes porous coated devices which are indicated for use without bone cement, and are single use devices.

B. DEVICE DESCRIPTION:

C. SUBSTANTIAL EQUIVALENCE INFORMATION:

Smith & Nephew, Inc. concludes that the Profix Total Knee System is substantially equivalent to the currently marketed knee prosthesis filed with the following premarket notifications: Profix Total Knee System (K933958), Profix Posterior-Stabilized Knee System (K954909), Profix Knee Posterior-Stabilized Plus Tibial Insert (K963255). Tricon Knee System (K884824), and Freeman-Samuelson Mark II Press-Fit Total Knee Replacement (K853730)

D. SUMMARY OF TECHNOLOGICAL COMPARISON:

The intended use, designs, and materials of the Profix Total Knee System are substantially equivalent to the predicate components found in the original Profix System submissions previously cleared by FDA.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2003

Mr. Gino J. Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. Orthpaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K030623

Trade/Device Name: Profix Total Knee System Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Codes: MBH Dated: February 26, 2003 Received: February 27, 2003

Dear Mr. Rouss:

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. Iisting 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

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Page 2 - Mr. Gino J. Rouss

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 (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,

Mark N Millerson

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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ﻻﻣﺔ ﺗﻤﺮﻳﺒﺎ

K030623 510(k) Number (if known):

Device Name: Smith & Nephew Profix Total Knee System

Indications For Use:

The Profix Total Knee System is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Profix Total Knee System includes porous coated devices which are indicated for use without bone cement, and are single use devices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__ OR Over-The-Counter Use_**_
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
urgical Devices
510(k) Number _**_K030623

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.