(149 days)
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System 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 unicompartmental knee replacement components for Unicompartmental High Flex Knee System prosthesis.
The provided text describes a 510(k) summary for the Zimmer Patient Specific Instruments System, outlining its intended use, technological characteristics, and performance data. However, it does not contain specific acceptance criteria with numerical targets, nor does it detail a study that explicitly proves the device meets such criteria in a quantitative manner as typically requested for AI/ML device evaluations.
Instead, the performance data section generally states that "Software validation and accuracy performance testing by means of saw bone models, cadaveric trials and guide deformation verification after sterilization were performed to assess the safety and effectiveness of the device." And "These tests verified that the accuracy and performance of the device is adequate to perform as intended."
This suggests a general validation rather than a study with defined acceptance criteria and corresponding quantitative results. The submission predates modern requirements that would typically necessitate detailed quantitative performance metrics for AI/ML components.
Given the information provided, I cannot populate the table or answer all requested questions with specific quantitative details. I will indicate where the information is not available in the provided text.
Here's an attempt to answer the questions based on the available text:
1. A table of acceptance criteria and the reported device performance
No specific numerical acceptance criteria or quantitative performance metrics are provided in the document. The performance data section broadly states: "These tests verified that the accuracy and performance of the device is adequate to perform as intended."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail (e.g., target accuracy, precision) | "Accuracy and performance of the device is adequate to perform as intended" based on software validation, saw bone models, cadaveric trials, and guide deformation verification after sterilization. (Specific numerical results are not provided). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text mentions "saw bone models" and "cadaveric trials" as part of non-clinical tests.
- Sample size: Not specified.
- Data provenance: "Saw bone models" and "cadaveric trials" imply laboratory-based testing, not clinical data from patients. The country of origin for this testing is not specified. It is inherently prospective in the context of the testing (i.e., conducted specifically for the submission).
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. The performance testing described (saw bone models, cadaveric trials, guide deformation) does not involve expert-established ground truth in the context of diagnostic interpretation or clinical decision-making. It's a physical or software accuracy validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device is not an AI/ML diagnostic interpretation system that would typically require expert adjudication for ground truth. The validation relies on measurements from physical models and cadavers.
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
No. An MRMC study is not mentioned. The device assists surgeons in positioning knee replacement components and guiding cuts, rather than providing interpretations for human readers to evaluate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device explicitly includes a "human-in-the-loop" step: "The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan." Therefore, a standalone (algorithm only) performance, separate from the surgeon's review and approval, is not described or indicated as being evaluated as such. The system is designed to be used with a surgeon's oversight.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests:
- For software validation and accuracy testing: Likely engineering specifications, direct measurements on saw bone models or cadavers (e.g., comparing planned cuts/positions to actual cuts/positions, or anatomical landmarks), and measurements related to guide deformation.
- The text states "These tests verified that the accuracy and performance of the device is adequate to perform as intended," implying comparison against an established engineering or anatomical ground truth, even if not explicitly detailed.
8. The sample size for the training set
Not applicable. The description does not indicate an Artificial Intelligence/Machine Learning (AI/ML) component that would typically require a "training set" in the modern sense. The "Zimmer Patient Specific Instruments Planner" is described as a "software component" that "generates a pre-surgical plan based on MRI imaging data." This sounds like rule-based software or traditional image processing, not a machine learning model that undergoes a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no indication of an AI/ML component requiring a training set with established ground truth in the context of machine learning.
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KILZZOI(113)
JAN - 6 2012
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 |
| Principal contact person | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | regulatory.affairs@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 8th of August.
Submission information
| Trade Name | Zimmer Patient Specific Instruments PlannerZimmer Patient Specific Instruments |
|---|---|
| Common Name | Knee prosthesis |
| Classification Name | Knee joint femorotibial metal/polymer non-constrainedcemented prosthesis |
| Product code | HSX/OOG (21 CFR § 888.3520) |
Predicate devices
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Zimmer Unicompartmental Knee System |
| 510(k) number | K033363 |
| Decision date | 01/16/2004 |
| Product code | HSX |
| Manufacturer | Zimmer, INC. |
Predicate Device
Signature™ Personalized Patient Care System Trade or proprietary or model name
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| 510(k) number | K110415 |
|---|---|
| Decision date | 05/16/2011 |
| Product code | HRY, JWH/OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Zimmer Patient Specific Instrument System 2.0 |
| 510(k) number | K093533 |
| Decision date | 02/17/2010 |
| Product code | JWH, MBH |
| Manufacturer | Materialise N.V. |
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 unicompartmental knee replacement components for Unicompartmental High Flex Knee System prosthesis.
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. 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 Unicompartmental Knee Replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual Unicompartmental Knee Replacement components by guiding and marking cut locations.
Intended use
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System 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 devices.
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Performance data
Non-clinical tests
Software validation and accuracy performance testing by means of saw bone models, cadaveric trials and guide deformation verification after sterilization were performed to assess the safety and effectiveness of the device.
These tests verified that the accuracy and performance of the device is adequate to perform as intended.
Clinical data
Non-clinical laboratory testing was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the device is adequate to perform as intended.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 6 2012
Materialise N.V. % Ms. Alexandra Razzhivina 15 Technologielaan Leuven, 3001 Belgium
Re: K112301
Trade/Device Name: The Zimmer Patient Specific Instruments System 3.0 Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prothesis Regulatory Class: Class II Product Code: HSX, OOG Dated: December 16, 2011 Received: December 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. 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
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Page 2 – Ms. Alexandra Razzhivina
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.
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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Indications for Use
510(k) Number (if known): K112301
Device Name: The Zimmer Patient Specific Instruments System 3.0
Indications for Use:
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System 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)
B.P. Ramilh for
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
Page 1 of 1
510(k) Number K112301
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.