(88 days)
Pin Placement Guides
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacement components and in guiding the marking of bone before cutting.
The Materialise TKA Guide System must 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 Persona™ CR fixed bearing, Zimmer Persona™ 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, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS prostheses families only.
The Materialise TKA Guides are intended for single use only.
Cut-Through Guides
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacements and in guiding the marking of bone before cutting of the bone.
The Materialise TKA Guide System must be used in conjunction with 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 and AGC™ Complete Knee system prostheses families only
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 Knee 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).
The provided text does not contain detailed information about specific acceptance criteria and a study that quantitatively proves the device meets those criteria. It primarily focuses on the device's substantial equivalence to predicate devices based on non-clinical tests and overall performance.
However, based on the information available, here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly list quantitative acceptance criteria for the device's performance. It generally states that "the accuracy and performance of the system is adequate to perform as intended." The "Reported Device Performance" section below is an interpretation of the general claims made.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied/inferred) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use Fulfillment | Device successfully assists in intra-operative positioning and guiding bone marking/cutting for TKA. | The device is "adequate to perform as intended" for assisting in intra-operative positioning of total knee replacement components and guiding marking/cutting of bone. |
| Accuracy and Performance | (Specific quantifiable accuracy metrics such as deviation from planned cuts, angular alignment errors, etc., are not provided.) | "The accuracy and performance of the system is adequate to perform as intended." |
| Biocompatibility | Device materials are biocompatible for single-use surgical instruments. | "Previous testing for biocompatibility... are applicable to the subject device and demonstrate substantial equivalence with the predicate devices." |
| Sterility | Device maintains sterility until use. | "Previous testing for... sterility... are applicable to the subject device and demonstrate substantial equivalence with the predicate devices." |
| Debris | Device does not generate unacceptable levels of debris. | "Previous testing for... debris... are applicable to the subject device and demonstrate substantial equivalence with the predicate devices." |
| Dimensional Stability | Device maintains its intended dimensions and shape during use. | "Previous testing for... dimensional stability are applicable to the subject device and demonstrate substantial equivalence with the predicate devices." |
| Packaging Integrity | Packaging protects the device and maintains sterility. | "An updated packaging test is performed." (No specific results are given, only that it was performed). |
| Manufacturing Quality | Device manufactured under established quality systems. | "The Materialise TKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Previous testing that the accuracy and performance of the system is adequate to perform as intended is applicable to the subject device." However, it does not provide information on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It refers to "previous testing" which implies data from predicate devices or earlier iterations, but no specifics are given for this submission.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used or their qualifications for establishing ground truth within any performance study. The device's function involves a "qualified surgeon" approving a pre-surgical plan, which inherently involves expert input, but this is part of the clinical use rather than a study's ground truth establishment.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or its results (effect size of human readers with/without AI assistance). The device is a surgical guide system, not an interpretive AI tool for diagnostic images, thus an MRMC study in the typical sense (e.g., for radiology AI) would not likely be applicable or reported here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device description emphasizes that the "Materialise TKA Guide System generates a pre-surgical plan... The software device then 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 workflow.
The document does not explicitly describe a standalone performance study (algorithm only, without human interaction) for the device. The system's design inherently involves surgeon approval of the plan before guide manufacturing.
7. Type of Ground Truth Used
The "ground truth" for this type of device, a surgical planning and guiding system, would typically relate to the accuracy of implementing the surgeon-approved pre-surgical plan relative to the actual bone cuts and component placement. However, the document does not explicitly state the type of ground truth used for verifying the system's "accuracy and performance." Given the nature of TKA guides, it would likely involve:
- Imaging-based comparisons: Post-operative CT or X-rays compared against the pre-operative plan to assess component alignment and cut accuracy.
- Intra-operative measurements: Direct measurement of pin hole locations or cut depths relative to the surgical plan.
- Expert Consensus/Surgeon Approval: The 'ground truth' of the plan itself is established by the surgeon's approval.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. The Materialise TKA Guide System is described as generating a pre-surgical plan based on MRI or CT images, and then designing guides. This suggests an engineering/design process rather than a machine learning model that requires a training set in the conventional sense. If its "planning" component uses algorithms, no training data for such algorithms is mentioned.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.
§ 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.