(135 days)
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee replacement components for Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally states that "Non-clinical tests were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended." and "Clinical cases performed confirmed the safety and effectiveness of the device."
2. Sample Size and Data Provenance for Test Set
The document mentions "Non-clinical tests" and "Clinical cases," but does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number and Qualifications of Experts for Ground Truth
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for Test Set
The document does not describe any adjudication method used for either non-clinical or clinical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The device is a surgical instrument system (software and hardware components) to assist surgeons, not strictly an AI diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance
The document describes the "Zimmer Patient Specific Instruments Planner" (software component) and "Zimmer Patient Specific Instruments" (hardware component) as parts of a system "designed to assist the surgeon." The software generates a pre-surgical plan which is then "inspected, fine-tuned and approved by a qualified surgeon." This indicates a human-in-the-loop process, and no standalone algorithm-only performance is described.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for Training Set
The document does not provide information on the sample size used for any training set.
9. How Ground Truth for Training Set Was Established
The document does not provide information on how ground truth was established for any training set.
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KIII492( Vz)
OCT 1 3 2011
510(k) Summary
Submitter information
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Contact name | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
| Additional contact person | Li Cher Chan |
| Contact title | Quality Responsible |
| Contact e-mail address | licher.chan@materialise.com.my |
| Additional contact person | Karl vom Berge |
| Contact title | Product Manager |
| Contact e-mail address | karl.vomberge@materialise.be |
Submission date
The date of the Traditional 510(k) submission is May 27th, 2011.
Submission information
| Trade Name | Zimmer Patient Specific InstrumentsZimmer Patient Specific Instruments Planner |
|---|---|
| Common Name | Knee prosthesis |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesisKnee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis |
| Product code | JWH, (21 CFR 888.3560), MBH (21 CFR 888.3565) and OOG (21 CFR888.3560) |
Predicate device
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Zimmer Patient Specific Instrument System 2.0 |
| 510(k) number | K093533 |
| Decision date | 17/02/2010 |
| Product code | JWH, MBH |
| Manufacturer | Materialise N.V. |
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Device Information
Description of the device
The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee replacement components for Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses.
Functioning of the device
The Zimmer Patient Specific Instruments System generates a pre-surgical plan based on MRI imaging data using the Zimmer Patient Specific Instruments Planner (software component). The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Zimmer Patient Specific Instruments are designed and manufactured based on the approved pre-surgical plan. Zimmer Patient Specific Instruments are patient specific templates that transfer the pre-operatively determined positioning of the Total Knee Replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual Total Knee Replacement components by guiding and marking drill locations.
Intended use
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Summary of technological characteristics
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.
Performance data
Non-clinical tests
Non-clinical tests were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
Clinical data
Clinical cases performed confirmed the safety and effectiveness of the device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, with two smaller curved lines representing the tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Materialise NV % Ms. Alexandra Razzhivina Regulatory Officer Technologielaan 15 3001 Leuven Belgium
OCT 1 3 2011
Re: K111492
Trade/Device Name: The Zimmer Patient Specific Instruments System 2.5 Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: September 15, 2011 Received: September 19, 2011
Dear Ms. Razzhivina:
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 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 issuunce 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); medical device reporting (reporting of medical
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Page 2 - Ms. Alexandra Razzhivina
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Euel Keith
for Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111492
Device Name: The Zimmer Patient Specific Instruments System 2.5
Indications for Use:
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Olsen to MXM
ivision of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K111492
§ 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.