(184 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 Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
The subject device Zimmer Patient Specific Instruments System 5.0 is a modification to the predicate device Zimmer Patient Specific Instruments System 2.5 (K111492) to accommodate the new compatible implant system Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses cleared via 510(k) K113369. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer Persona CR fixed bearing and Zimmer Persona PS 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).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly detail specific quantitative acceptance criteria. Instead, it states that "the accuracy and performance of the system is adequate to perform as intended" based on non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adequate accuracy for pre-surgical planning | "accuracy...is adequate to perform as intended" |
| Adequate performance for assisting in component positioning | "performance...is adequate to perform as intended" |
| Safe and effective for intended use | "Results of software verification testing demonstrated the device can be used safe and effective as intended" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of a specific number of cases or patients. The testing was conducted using "cadaveric specimens and saw bones."
- Data Provenance: The testing was non-clinical. The "cadaveric specimens and saw bones" represent simulated rather than real patient data. There is no information on the country of origin, and it is inherently a prospective test on these simulated models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The ground truth for the non-clinical tests on cadaveric specimens and saw bones would likely be established through precise measurements and physical verification, not expert consensus. There is no mention of experts being involved in establishing the ground truth for this testing.
4. Adjudication Method for the Test Set:
Not applicable. As the testing was non-clinical using cadaveric specimens and saw bones, and ground truth was likely established through physical measurements, there would be no need for an adjudication method among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document focuses on the device's standalone performance and its substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance evaluation of the algorithm (referred to as the "system") was done. The "Performance Data" section states: "Non-clinical tests using cadaveric specimens and saw bones 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. Results of software verification testing demonstrated the device can be used safe and effective as intended." This indicates that the device's functional performance was evaluated independently.
7. Type of Ground Truth Used:
The ground truth used for the non-clinical tests would have been based on physical measurements and known anatomical features/target positions on the cadaveric specimens and saw bones. This is a form of objective, empirical ground truth rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical studies.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. The focus is on the testing of the final device, not on its development or training phase.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no information on a training set is provided.
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Zimmer Patient Specific Instrument System 5.0 510(k) Premarket Notification
510(k) Summary
510(k) Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
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 Wim Claassen Contact title Product Manager Contact e-mail address Wim.Claassen@materialise.be
Submission date
The date of the Traditional 510(k) submission is June 15, 2012 .
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 prosthesis |
| Product code | JWH, OOG (21 CFR 888.3560) |
Predicate Devices
Materialise N.V.
ਹੈ ਤ
5 2012
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K121640*#213
Zimmer Patient Specific Instrument System 5.0 510(k) Premarket Notification
510(k) Summary
The predicate device to which substantial equivalence is claimed to:
| Trade or property or model name | Zimmer Patient Specific Instruments System 2.5 |
|---|---|
| 510(k) number | K111492 |
| Decision date | 10/13/2011 |
| Product code | JWH, OOG (21 CFR 888.3560), MBH (21 CFR 888.3565) |
| Manufacturer | Materialise NV |
| Materialise USA, LLC |
| Trade or property or model name | Signature™ Personalized Patient Care System |
|---|---|
| 510(k) number | K102795 |
| Decision date | 02/02/2011 |
| Product code | JWH, OIY, MBH, OOG |
| Manufacturer | Materialise NV |
| Materialise USA, LLC |
Device Description
The subject device Zimmer Patient Specific Instruments System 5.0 is a modification to the predicate device Zimmer Patient Specific Instruments System 2.5 (K111492) to accommodate the new compatible implant system Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses cleared via 510(k) K113369. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer Persona CR fixed bearing and Zimmer Persona PS 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).
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 Persona CR fixed bearing and Zimmer Persona PS 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 5.0 generates a pre-surgical plan based on MRI 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.
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K121640#31/3
Zimmer Patient Specific Instrument System 5.0 510(k) Premarket Notification
510(k) Summary
Technological Characteristics
A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the predicate devices.
Performance Data
Non-clinical tests using cadaveric specimens and saw bones 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. Results of software verification testing demonstrated the device can be used safe and effective as intended.
Summary
The characteristics that determine the functionality and performance of the subject device, the Zimmer Patient Specific Instruments System 5.0, are substantially equivalent to the device cleared under K111492. 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 is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 5, 2012
Materialise N.V. % Ms. Alexandra Razzhivina Technologielaan 15 3001 Leuven Belgium
Re: K121640
Trade/Device Name: Zimmer Patient Specific Instruments System 5.0 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, OOG Dated: November 26, 2012 Received: November 28, 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
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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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 《니쇼) 뉴닝((
Zimmer Patient Specific Instruments System 5.0 (Zimmer Patient Specific Device Name: Instruments Planner, Zimmer Patient Specific Instruments)
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 Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Prescription Use × (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices 2012.12.04 14:54:07 -05'00'
Page 1 of _1
§ 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.