(189 days)
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems. Vanguard™ M Unicompartmental Knee System and Oxford® Partial Knee System prostheses families only.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
Materialise PKA Guides are patient-specific medical devices that are designed to implant partial knee prosthesis.
The Materialise PKA Guides must only be used in conjunction with the 510(k) cleared, legally marketed prosthesis. Consult the prosthesis labeling and instructions for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Moterialise PKA Guides is an instrument set containing a femur and/or tibia template(s) and bone models.
This document describes a 510(k) premarket notification for the Materialise PKA Guide System. It is a surgical instrument intended to assist in the positioning of Partial Knee Replacement components.
Based on the provided text, the device itself is not a diagnostic AI/ML algorithm. Instead, it seems to be software that assists in pre-surgical planning (Materialise PKA Planner) which then informs the design of patient-specific surgical guides (Materialise PKA Guides) created for physical use during surgery. The "Performance Data" section explicitly states, "No new testing of the Materialise PKA Guides was done in support of this pre-market notification." and "New software validation/verification testing of the Materialise PKA Planner was done in support of this pre-market notification in the form of usability evaluations."
Therefore, the document does not contain information about acceptance criteria or a study that proves an AI/ML device meets certain performance metrics, especially not in the context of diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance. It focuses on demonstrating substantial equivalence to predicate devices for a surgical guide system.
In particular, the request asks for:
- A table of acceptance criteria and the reported device performance: Not present for an AI/ML diagnostic. The document refers to "usability evaluations" for the software.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML diagnostic test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not done and not applicable to this device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "Materialise PKA Planner" software requires a surgeon to "inspect, fine-tune and approve the pre-surgical plan."
- The type of ground truth used: Not applicable for an AI/ML diagnostic. The "ground truth" for the surgical guides is based on the pre-surgical plan approved by the surgeon and the intended anatomical alignment during surgery.
- The sample size for the training set: Not applicable, as this is not an ML algorithm in the sense of being "trained" on a large dataset for diagnosis.
- How the ground truth for the training set was established: Not applicable.
The document discusses "Performance Data" but this refers to non-clinical testing for biocompatibility, sterility, cleaning, debris, dimensional stability, and the applicability of previous cadaver testing for guidance stability. For the software component, it mentions "usability evaluations."
Conclusion: The provided document is for a medical device (surgical guide system and its planning software) and does not contain the information requested about the acceptance criteria and study proving an AI/ML diagnostic device's performance. The device is not an AI/ML diagnostic.
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July 6, 2018
Materialise NV Oliver Clemens Regulatory Officer Technologielaan 15 Leuven, 3001 Be
Re: K173970
Trade/Device Name: Materialise PKA Guide System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, OOG Dated: December 29, 2017 Received: December 29, 2017
Dear Oliver Clemens:
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. Iisting 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 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Vincent J. Devlin -S for 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) K173970
Device Name Materialise PKA Guide System
Indications for Use (Describe)
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems. Vanguard™ M Unicompartmental Knee System and Oxford® Partial Knee System prostheses families only.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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
| 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 | Oliver Clemens |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Wim Claassen |
| Contact title | Portfolio Manager |
| Contact e-mail address | Wim.Claassen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is December 21, 2017.
Submission information
| Device name | Materialise PKA Guide System |
|---|---|
| Trade Name | Materialise PKA PlannerMaterialise PKA GuideSurgiCase PlannerVisionaire UNI cutting guidesSignature PlannerSignature GuidesZimmer Patient Specific Instruments PlannerZimmer Patient Specific Instruments |
| Common Name | Knee prosthesis |
| Classification Name | Knee joint patellofemorotibial polymer /metal /polymer semi-constrained cemented prosthesis |
| Primary product code | HSX (21 CFR 888.3520) |
| Subsequent product codes | OOG |
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Predicate Devices
The predicate devices to which substantial equivalence is claimed:
| Trade or proprietary or model name | Materialise PKA Guide System |
|---|---|
| 510(k) number | K172650 |
| Decision date | November 20, 2017 |
| Classification product code | HSX (21 CFR 888.3520) |
| Subsequent product codes | OOG |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Signature Personalized Patient Care System |
|---|---|
| 510(k) number | K110415 |
| Decision date | May 16, 2011 |
| Classification product code | HRY (21 CFR 888.3530) |
| Subsequent product codes | JWH, MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Materialise TKA Guide System |
|---|---|
| 510(k) number | K173445 |
| Decision date | February 2, 2018 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
Device Description
Materialise PKA Guides are patient-specific medical devices that are designed to implant partial knee prosthesis.
The Materialise PKA Guides must only be used in conjunction with the 510(k) cleared, legally marketed prosthesis. Consult the prosthesis labeling and instructions for specific patient indications, contraindications, associated
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risks, information for use, warnings and precautions. Moterialise PKA Guides is an instrument set containing a femur and/or tibia template(s) and bone models.
Intended Use
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System and Oxford® Partial Knee System prostheses families only.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
Functioning of the Device
The Materialise PKA Guide System generates a pre-surgical plan based on MRI images using the Materialise PKA Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Materialise PKA Guides are designed based on the approved presurgical plan. Materialise PKA Guides are patient specific templates which transfer the pre-operatively determined positioning of the chosen partial knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual partial knee replacement components by guiding the marking of bone before cutting and to guide cutting of the bone.
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 main difference between the subject device and previously cleared predicate device K172650 is the Oxford and Vanguard M implants in the Planner software for the surgeon to select during stage. The software algorithm was extended with an Oxford specific planning algorithm which was previously cleared as part of the software component of predicate device K110415. Furthermore, the medical coordinate system and clinical relevant landmarks for the PKA Oxford specific planning algorithm were aligned with those of the TKA procedure as cleared in predicate device K173445. The changes do not affect the safety and effectiveness of the devices.
Performance Data
No new testing of the Materialise PKA Guides was done in support of this pre-market notification. Previous testing for biocompatibility, sterility, cleaning, debris and dimensional stability are applicable to the subject device and demonstrate substantial equivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are the same as that of the predicate Signature Personalized Patient Care System (K110415) and therefore previous cadaver testing on predicate device K110415 is considered applicable to the subject device. New software validation/verification testing of the Materialise PKA Planner was done in support of this pre-market notification in the form of usability evaluations.
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Summary
The characteristics that determine the functionality and performance of the Materialise PKA Guide System are substantially equivalent to the devices cleared under K172650 and K110415. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates. The Materialise PKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.
§ 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.