(28 days)
The Sigma XLK Tibial Inserts 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 DePuy Sigma XLK Tibial Inserts are posterior lipped, cruciate retaining or stabilized tibial inserts with the same design and intended use as the tibial inserts cleared in K033272. The subject inserts are manufactured from XLK Crossfinked Polycthylene. The Sigma XLK Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.
The provided document is a 510(k) premarket notification for a medical device (DePuy Sigma XLK Tibial Inserts) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical wear testing. It does not contain information about a clinical study involving human readers or the components typically found in such a study (like acceptance criteria for diagnostic accuracy, expert review, training sets, etc.).
However, I can extract the information provided regarding the mechanical wear performance.
Acceptance Criteria and Study for DePuy Sigma XLK Tibial Inserts
The study described is an in-vitro knee simulator wear test, not a clinical study involving human readers or diagnostic performance. The "acceptance criteria" here relate to the wear performance of the device compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Criteria | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Gravimetric Wear | To exhibit similar or less wear than the predicate Darwin tibial inserts. Explicit numerical acceptance for "less wear" is not stated, but the claim is for a significant reduction. | The DePuy XLK Sigma Tibial Inserts exhibit 89% less gravimetric wear than previously cleared Johnson & Johnson Darwin tibial inserts. |
| Mechanical Performance | Perform similarly to Sigma and Darwin Inserts in mechanical testing. | Mechanical testing shows similar performance. |
Note: The document explicitly states: "The results of in-vitro wear tests have not been shown to correlate with clinical wear mechanisms." This is an important disclaimer.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Wear Test):
- DePuy Sigma XLK Tibial Inserts: n = 3 (Size 3, 10mm cruciate retaining)
- Johnson & Johnson Darwin (PFC Sigma) Tibial Inserts (predicate): n = 6 (Size 3, 10mm cruciate retaining)
- Data Provenance: The data is from an in-vitro knee simulator wear study conducted by the manufacturer, DePuy Orthopaedics, Inc. (USA). This is a laboratory-based study, not a clinical study involving human patients or data from a specific country of origin in the context of clinical outcomes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this document. The study described is an in-vitro mechanical wear test, not a study requiring expert consensus for a ground truth.
4. Adjudication Method for the Test Set
This information is not applicable to this document, as there was no expert review or adjudication in this in-vitro mechanical study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical performance and substantial equivalence of a medical implant, not the diagnostic efficacy of an imaging device or AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about a knee implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measured gravimetric wear of the tibial inserts under controlled laboratory conditions using a knee joint simulator, based on physical material loss.
8. The Sample Size for the Training Set
Not applicable. This study is not an AI algorithm study and therefore has no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no ground truth to establish for it in this context.
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FEB 2 3 2004
KO4066
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 XLK Tibial Inserts |
| COMMON NAME: | Total Knee Joint Replacement Prosthesis |
| CLASSIFICATION: | 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis; Class II |
| DEVICE PRODUCT CODE: | 87 JWI1 |
| SUBSTANTIALLY EQUIVALENTDEVICE: | DePuy Sigma Tibial Inserts - K033272Johnson & Johnson (now DePuy) Darwin KneeSystem - K943462, K950010, K961685,K971189 |
DEVICE DESCRIPTION:
The DePuy Sigma XLK Tibial Inserts are posterior lipped, cruciate retaining or stabilized tibial inserts with the same design and intended use as the tibial inserts cleared in K033272. The subject inserts are manufactured from XLK Crossfinked Polycthylene. The Sigma XLK Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.
When tested with DePuy Sigma Co-Cr Tibial Trays, the DePuy XLK Sigma Tibial Inserts exhibit 89% less gravimetric wear than previously cleared Johnson & Johnson Darwin tibial inserts tested with Johnson & Johnson PFC tibial trays. This claim is supported by 5 million cycle knee simulator wear data. The products tested were Size 3 Sigma Co-Cr Tibial Trays mated with Size 3, 10mm cruciate retaining Sigma XLK Tibial Inserts (n= 3) compared to Size 3 PFC Titanium Trays mated with Size 3, 10mm cruciate retaining Darwin (PFC Sigma) Tibial Inserts (n= 6). Both sets of inserts were articulated against Size 3 cast Co-Cr PFC Sigma cruciate retaining, non-porous coated femoral components. All tibial trays and femoral components were sterilized using ganma irradiation. The Sigma XLK inserts were sterilized using gas plasma sterilization. The Darwin Tibiah Inserts were sterilized using gamma vacuum foil (GVF) sterilization and packaging. Testing was conducted on a AMTI multi-axial displacement controlled knee joint simulator using bovine serum as a lubricant.
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Koholl
The results of in-vitro wear tests have not been shown to correlate with clinical wear mechanisms.
INTENDED USE AND INDICATIONS:
The Sigma XLK Tibial Inserts 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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Sigma XLK Tibial Inserts have the same design and intended use as the Sigma Inserts cleared in K033272. Mechanical testing shows that the Sigma XLK Tibial Inserts perform similarly to the Sigma and Darwin Inserts but exhibit less wear in knee simulator testing. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the Sigma Tibial XLK Inserts are substantially equivalent to the previously cleared Sigma and Darwin Tibial Inserts.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2004
Ms. Cheryl K. Hastings Director, Regulatory Affairs DePuv Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K040166
Trade/Device Name: DePuy Sigma XLK Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knce joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 24, 2004 Received: January 26, 2004
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, 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. Cheryl K. Hastings
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manag 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 If you desire specific at not 101 your 201) 594-4659. Also, please note the regulation entitled, contact the Orited of Computers and (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 A. Millikan
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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Indications for Use
510(k) Number (if known): K040166__________________________________________________________________________________________________________________________________________
Device Name: __DePuy Sigma XLK Tibial Inserts
Indications for Use:
Prescription Use
The Sigma XLK Tibial Inserts 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.
| Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|---|---|---|
| ---------------------------------------------- | -------- | --------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
for Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K040166 |
|---|---|
| --------------- | --------- |
(Posted November 13, 2003)
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Over-The-Counter Use ________
§ 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.