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.

Device Description

The subject device Zimmer Patient Specific Instruments System 4.0 is an upgrade of the predicate device Zimmer Patient Specific Instruments System 2.5 and is designed to assist a 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. The system consists of a software device, branded as Zimmer Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer Patient Specific Instruments (ZPSI). Use of Zimmer Patient Specific Instruments is limited to the treaticular deformities only.

AI/ML Overview

The provided text describes a 510(k) submission for the Zimmer Patient Specific Instruments System 4.0. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment methods, or specific performance metrics.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K111492 and K102795) and describes the device's intended use and technological characteristics.

Here's a breakdown of what can be extracted and what is missing:

What can be extracted:

Device Name: Zimmer Patient Specific Instruments System 4.0 (Zimmer Patient Specific Instruments Planner, Zimmer Patient Specific Instruments)
Intended Use: To assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting, provided anatomic landmarks are identifiable on patient imaging scans. It is specifically for use with certain Zimmer NexGen prostheses families.

What is missing from the provided text:

A table of acceptance criteria and the reported device performance: This information is not explicitly stated in the document. The text only vaguely mentions, "Testing verified that the accuracy and performance of the system is adequate to perform as intended." No specific metrics, thresholds, or reported performance values are provided.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The description of the device's function suggests it's an "assistive" system for surgeons ("to assist a surgeon," "assisting the surgeon"), implying a human-in-the-loop scenario. However, a specific standalone performance study is not detailed. The "Zimmer Patient Specific Instruments Planner (ZPSIP)" software generates a pre-surgical plan which is then "inspected, fine-tuned and approved" by a surgeon, indicating human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. The system generates a "pre-surgical plan" and then "patient specific templates" are designed based on this plan. The accuracy of these, which would logically be compared to a ground truth, is not described in terms of how that ground truth was established.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Conclusion:

While the document confirms that "Non-clinical tests have been performed to assess the safety and effectiveness of the subject device," and that "Testing verified that the accuracy and performance of the system is adequate to perform as intended," it does not provide the specific details of these tests, including acceptance criteria, performance results, study designs, sample sizes, or ground truth establishment methods.

This level of detail is typically found in the full 510(k) submission, specifically in the "Performance Data" section, which is summarized but not fully presented in this 510(k) Summary. The summary focuses on establishing substantial equivalence based on intended use, materials, and technological characteristics without delving into the raw performance data that would address your specific questions.

Summary

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510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

Submitter's 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
Principal Contact person	Alexandra Razzhivina
Contact title	Regulatory Officer
Contact e-mail address	Regulatory. Affairs@materialise.be
Additional contact person	Karl vom Berge
Contact title	Product Manager
Contact e-mail address	Karl.Vomberge@materialise.be
Additional contact person	Wim Claassen
Contact title	Project Manager
Contact e-mail address	Wim.Claassen@materialise.be

Submission date

The date of the Traditional 510(k) submission is December 230, 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)OOG (21 CFR 888.3560)

Predicate Devices

ﭘﺎ ﺗ

The predicate device to which substantial equivalence is claimed to:

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K113829
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Trade or proprietary or model name	Zimmer Patient Specific Instrument System 2.5
510(k) number	K111492
Decision date	17/02/2010
Product code	JWH (21 CFR 888.3560)MBH (21 CFR 888.3565)
Manufacturer	Materialise N.V.
Trade or proprietary or model name	SignatureTM Personalized Patient Care System
510(k) number	K102795
Decision date	02/02/2011
Product code	JWH (21 CFR 888.3560)OIY (21 CFR 888.3560)MBH (21 CFR 888.3565)OOG (21 CFR 888.3565)
Manufacturer	Materialise N.V.

Device Description

Intended Use

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.

Functioning of the Device

The Zimmer Patient Specific Instruments System 4.0 generates a pre-surgical plan based on computed tomography (CT) image data sets using the Zimmer Patient Specific Instruments Planner. The software device then is 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 which transfer the pre-operatively determined positioning of the chosen 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.

Technological Characteristics

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A detailed comparison shows the subject device is substantially equivalent in intended use, materials and performance characteristics to the proposed predicate devices.

Performance Data

Non-clinical tests have been performed to assess the safety and effectiveness of the subject device. Testing verified that the accuracy and performance of the system is adequate to perform as intended.

Summary

The characteristics that determine the functionality and performance of the subject device, the Zimmer Patient Specific Instruments System 4.0, are substantially equivalent to those cleared under K111492 and K102795. The Zimmer Patient Specific Instrument System will be manufactured in compliance with FDA and ISO quality system requirements.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Materialise N.V. % Ms. Alexandra Razzhivina Technologielaan 15. Leuven, Belgium 3001

APR - 2 2012

Re: K113829

Trade/Device Name: Zimmer Patient Specific Instrument System 4.0 Regulation Number: 21 CFR 888.3560

Regulation Name: Knee joint patellofemorotibial metal/polymer semi-constrained cemented prosthesis.

Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: March 21, 2012 Received: March 23, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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); medical device reporting (reporting of medical 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.

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Page 2 – Ms. Alexandra Razzhivina

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/CDRHOffices/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, ·

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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K113829.

Dage II

Indications for Use

510(k) Number (if known):

Device Name: Zimmer Patient Specific Instruments System 4.0 (Zimmer Patient Specific Instruments Planner, Zimmer Patient Specific Instruments)

Indications for Use:

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)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

510(k) Number K113829

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.