(87 days)
The Materialise TKA Guide 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 provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Materialise TKA Guide 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. Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR and Omni Apex PS total knee prostheses during total knee arthroplasty surgical procedures.
The Materialise TKA Guides are intended for single use only.
Materialise TKA Guides are patient-specific medical devices that are designed to implant total knee prosthesis during total knee arthroplasty surgical procedures.
The Materialise TKA Guides must only be used in conjunction with the Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persond™ CR fixed bearing, Zimmer Persong™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS total knee prostheses. Consult the prosthesis labeling and instructions for use for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).
Here's a breakdown of the acceptance criteria and study information for the Materialise TKA Guide System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it relies on a validation study to demonstrate "accuracy and performance...adequate to perform as intended" and "substantial equivalence" to a predicate device.
| Performance Metric (Implicit) | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy of Plan Transfer | Adequate transfer of the pre-surgical plan to actual patient anatomy in a simulated environment, demonstrating substantial equivalence to the predicate device. | "The patient specific templates were subjected to a sawbone validation test in order to validate the use of the Materialise TKA Guide System and to demonstrate that the performance of the subject device is substantially equivalent to the predicate device (K150928) with respect to transferring a pre-surgical plan to actual patient anatomy in a simulated environment. Testing verified that the accuracy and performance of the system is adequate to perform as intended." Details of "adequate" are not quantified. |
| Functionality | The system can generate a pre-surgical plan, allow surgeon review/approval, design guides, and the guides can assist in positioning and aligning components intra-operatively. | The document describes the functioning of the device as generating a pre-surgical plan, allowing surgeon fine-tuning and approval, designing and manufacturing patient-specific guides, and the guides assisting in intra-operative positioning, alignment, and marking drill locations for total knee replacement components. The validation study implies this functionality was successfully demonstrated. |
| Compatibility | Compatibility with an established list of total knee arthroplasty implants, including additional ones for the subject device. | The device is compatible with a comprehensive list of Zimmer, Vanguard, Regenerex, Maxim, Ascent, AGC, Consensus, Lima Physica, and Omni Apex total knee prostheses. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of cases or subjects. The document refers to a "sawbone validation test" and "patient specific templates," implying a number of templates/sawbones were tested. However, the exact quantity is not provided.
- Data Provenance: The study was a "sawbone validation test" performed in a "simulated environment." This indicates it was a laboratory-based, prospective test using cadaveric or synthetic bone models (sawbones). The country of origin of the data is not specified, but the applicant company is based in Belgium.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the "functioning of the device" section states the pre-surgical plan is "used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan." This suggests involvement of qualified surgeons in establishing the intended surgical plan which the device is then validated against. Whether these "qualified surgeons" also established the ground truth measurements for the sawbones is not explicitly stated.
4. Adjudication Method for the Test Set
Not applicable/Not described. The study appears to be a technical validation of accuracy against a predefined surgical plan, rather than a clinical interpretation study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. The validation focused on the device's accuracy in transferring a pre-surgical plan using sawbones, not on improving human reader performance with or without AI assistance. The device is a surgical instrument/guide, not an AI diagnostic aid for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone study of the device's performance (specifically the patient-specific templates in a simulated environment) was done. The "sawbone validation test" assessed the accuracy and performance of the Materialise TKA Guide System in transferring a pre-surgical plan to actual patient anatomy in a simulated environment, independent of a human surgeon's real-time decision-making beyond the initial plan approval.
7. The Type of Ground Truth Used
The ground truth used was based on the pre-surgical plan approved by a qualified surgeon. The sawbone validation test aimed to demonstrate that the physical guides accurately transferred this approved plan to the simulated bone anatomy.
8. The Sample Size for the Training Set
Not applicable. The Materialise TKA Guide System is a patient-specific surgical guide system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its design is based on engineering principles and CAD/CAM from patient imaging data, not a machine learning model trained on a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of a machine learning algorithm. The "ground truth" for the device's design would be the established anatomical landmarks and biomechanical principles of total knee arthroplasty, and the surgeon's approved pre-surgical plan generated using the Materialise TKA Planner software.
§ 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.