(93 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. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN LPS-FLEX 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 Gender Solutions Natural – Knee Flex fixed bearing prostheses families.
The provided text describes the Zimmer Patient Specific Instruments System, which includes a software component (Zimmer Patient Specific Instruments Planner) and a hardware component (Zimmer Patient Specific Instruments). The system is designed to assist surgeons in the placement of total knee replacement components.
However, the 510(k) summary does not contain detailed information about specific acceptance criteria or a comprehensive study report proving the device meets particular benchmarks. The performance data section is very brief, stating:
"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 for clinical data: "Not applicable."
Therefore, based solely on the provided text, a full table of acceptance criteria and a detailed study description cannot be generated. The document primarily focuses on regulatory submission details, device description, and substantial equivalence to a predicate device, rather than a detailed performance study.
Here's an attempt to answer the questions based on the limited information available in the provided document, acknowledging significant gaps:
Acceptance Criteria and Device Performance Study (Based on Limited Information)
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria or detailed performance metrics are not explicitly stated. The document only provides a high-level qualitative statement regarding performance.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from Document) |
|---|---|
| Safety and Effectiveness | Non-clinical tests performed to assess safety and effectiveness. |
| Accuracy and Performance | Testing verified that the accuracy and performance of the system is adequate to perform as intended. (No specific metrics provided) |
| Intended Use Fulfillment | The device functions as intended to assist in positioning and guiding marking for TKR components. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify any sample sizes for test sets or data provenance. The "non-clinical tests" are mentioned without further detail regarding the nature of data used.
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)
The document does not provide any information about experts used for establishing ground truth or their qualifications. The "non-clinical tests" are not described with this level of detail.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information about adjudication methods.
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
The document does not describe an MRMC study, nor does it mention any comparison of human readers with or without AI assistance. The system is described as assisting the surgeon, but no comparative effectiveness data is presented. The device is a planning and guiding system, not an AI for interpretation that would involve "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The software component (Zimmer Patient Specific Instruments Planner) is used pre-operatively by a qualified surgeon to "inspect, fine-tune and approve the pre-surgical plan." This indicates a human-in-the-loop process. The document does not describe a standalone algorithm-only performance evaluation for the planning software. The hardware component (Zimmer Patient Specific Instruments) is a patient-specific template, which is by nature a standalone manufactured item based on the approved plan.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for its "non-clinical tests." For a device that assists in positioning, ground truth would typically relate to anatomical accuracy of the generated plan or the delivered template's guidance, but no details are provided.
8. The sample size for the training set
The document does not mention a training set sample size. Given the submission date (2009) and the description, it's unclear if "AI" in the modern sense of machine learning was heavily involved in a way that would necessitate a large training set as understood today. The software generates a pre-surgical plan based on MRI data, which could imply rule-based algorithms or image processing, rather than deep learning requiring extensive training data.
9. How the ground truth for the training set was established
The document does not provide any information about a training set or how its ground truth might have been established.
Conclusion:
The provided 510(k) summary for K093533 is very high-level regarding performance data. It explicitly states "Clinical data: Not applicable" and provides only a generic statement about non-clinical tests verifying "adequacy" of accuracy and performance. It lacks the detailed information typically found in study reports for specific acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.
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K093533 #1/2
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 66 75 |
| Fax number | +32 16 39 66 06 |
| Contact name | 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 November 13th, 2009.
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) and MBH (21 CFR § 888.3565) |
Predicate device
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Patient Matched Cutting Blocks |
| 510(k) number | K082358 |
| Decision date | 11/25/2008 |
| Product code | JWH, MBH |
| Manufacturer | Smith and Nephew, Inc. |
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 Gender Solutions Natural – Knee Flex fixed bearing prostheses families.
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K093533#a/2
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. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN LPS-FLEX 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
Not applicable.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like form in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Materialise N.V. % Mr. Karl vom Berge l 5 Technologielaan Leuven Belgium 3001
FEB 1 7 2010
Re: K093533
Trade/Device Name: Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: November 13, 2009 Received: November 19, 2009
Dear Mr. vom Berge:
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 – Mr. Karl vom Berge
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 mumber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
signature
ACTING
DSORD DIRECTOR
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): K0935333
Device Name: Zimmer Patient Specific Instruments System (Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner)
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. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN LPS-FLEX 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)
FOR M. MELKERSON
ision Sign-Off Division Sign-Oical, Orthopedic, Orthopedic, Division of Surgical Divisionative Devices
Page 1 of 1
510(k) Number
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.