The Sigma Co-Cr Tibial Trays are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The Sigma Co-Cr Tibial Trays are intended for cemented use only.

Device Description

The DePuy Sigma Co-Cr Tibial Trays are Co-Cr-Mo alloy tibial trays similar in design to the Darwin tibial trays cleared in K943462. The Sigma Co-Cr Tibial Trays are intended for use with the Darwin (now PFC Sigma) femoral and patella components, previously cleared in K943462.

AI/ML Overview

This document describes a medical device, the DePuy Sigma Co-Cr Tibial Trays, and its regulatory submission. It is a 510(k) premarket notification, which means the manufacturer is claiming that their new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This type of submission generally does not involve a clinical study to prove new acceptance criteria based on performance because the device is not claiming novel performance, but rather equivalence in safety and effectiveness to a predicate.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for a device performance study is not applicable to this 510(k) submission.

Instead, the "acceptance criteria" and "study" in this context refer to the criteria for demonstrating substantial equivalence to the predicate device, which is a regulatory assessment rather than a performance study.

Here's how to address the questions given the nature of a 510(k) for substantial equivalence:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are the demonstration of equivalence to the predicate, and the "performance" is a comparison to the predicate's known characteristics.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Same Intended Use as the predicate device.	The Sigma Co-Cr Tibial Trays have the "same intended use" as the tibial trays of the Darwin Knee System (K943462). Both are for total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage from conditions like rheumatoid arthritis, osteoarthritis, etc., and are intended for cemented use only.
Similar Design to the predicate device.	The Sigma Co-Cr Tibial Trays are "similar in design" to the Darwin tibial trays cleared in K943462. They can be used with the existing PFC Sigma femoral and patella components (which were previously cleared with the Darwin system).
Similar Materials to the predicate device, or changes do not raise new questions of safety or effectiveness.	The tibial tray material has been changed from forged Ti-6Al-4V alloy (predicate) to forged Co-Cr-Mo alloy (new device). The documentation implies this change does not raise new questions of safety or effectiveness, as it states "Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the Sigma Co-Cr Tibial Trays are substantially equivalent." (Further material testing, e.g., biocompatibility, mechanical properties, would have been submitted to demonstrate this, but explicit results are not detailed in this summary.)
Similar Manufacturing Method to the predicate device.	The documentation explicitly states "similarities in... manufacturing method."
No New Questions of Safety or Effectiveness are raised by the differences.	The FDA's substantial equivalence determination implies they agree that no new questions of safety or effectiveness were raised.

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. This is a claim of substantial equivalence based on design, materials, manufacturing, and intended use comparison, not a clinical performance study with test sets or data provenance.

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. There was no "ground truth" to establish for a test set in the context of a clinical performance study. The "ground truth" here is the regulatory determination of substantial equivalence by the FDA, based on the submitted information and comparison to the predicate device.

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

Not applicable. There was no "test set" for clinical performance that would require an adjudication method.

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 device is a total knee joint replacement prosthesis (a physical implant), not a diagnostic device or AI system that would involve human readers or AI assistance.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable to a clinical performance study. The "ground truth" in this regulatory context is the established safety and effectiveness profile of the predicate device, to which the new device is compared for equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

Summary

{0}------------------------------------------------

032151

Page 1 of 1

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) CONTACT:	Cheryl HastingsDirector, Regulatory Affairs
TRADE NAME:	DePuy Sigma Co-Cr Tibial Trays
COMMON NAME:	Total Knee Joint Replacement Prosthesis
CLASSIFICATION:	888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis; Class II
DEVICE PRODUCT CODE:	87 JWH
SUBSTANTIALLY EQUIVALENTDEVICE:	Johnson & Johnson Professional, Inc. (now DePuy)Darwin Knee System - K943462

DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Sigma Co-Cr Tibial Trays have the same basic design and the same intended use as the tibial trays of the Darwin Knee System. Like the Darwin trays, the Sigma Co-Cr trays can be used with the existing PFC Sigma femoral and patella components. The tibial tray material has been changed from forged Ti-6Al-4V alloy to forged Co-Cr-Mo alloy. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the Sigma Co-Cr Tibial Trays are substantially equivalent to the previously cleared trays of the Darwin Knee System.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

SEP 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw. Indiana 46581-0988

Re: K032151

Trade/Device Name: DePuy Sigma Co-Cr Tibial Trays 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: August 27, 2003 Received: August 28, 2003

Dear Ms. Hastings:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

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 vours,

Sincerely yours,

Mark N Millman

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

{3}------------------------------------------------

Indications Statement

510(k) Number (if known) K032151

Device Name DePuy Sigma Co-Cr Tibial Trays

Intended Use and Indications:

Concurrence of CDRH, Office of Device Evaluation

for Mark N. Millican

Tivision Sign-Off) Latision of General, Restorative and Neurological Devices Kossalis

510(k) Number_

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The Counter Use

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.