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Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

• Pin Placement Guides
The Materialise TKA Guides are 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 Guides 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides
The Materialise TKA Guides are 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 and cutting of the bone.

The Materialise TKA Guides must be used in conjunction with the 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.

• Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software
The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

The Materialise TKA Guide System is a medical device designed to be used to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a presurgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.

The subject device is a system that consists of the following two functional components:

• A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.

• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and to guide cutting of the bone. The patient-specific models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

The provided FDA 510(k) clearance letter and summary for the Materialise TKA Guide System describes the device and its indications for use, but it does not contain the specific acceptance criteria or the details of a study (like a clinical study or specific performance data) that proves the device meets those criteria.

Instead, the document primarily focuses on establishing "substantial equivalence" to a predicate device (Materialise TKA Guide System K221337) and a reference device (Materialise PKA Guide System K202207). It states that "The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device." However, it does not provide the actual results of this non-clinical performance testing in terms of specific acceptance criteria and detailed study outcomes.

The information given is typical for a 510(k) summary, which generally affirms that V&V (Verification and Validation) was done and that the device performs as intended, but it doesn't usually include the granular details of the V&V studies themselves, especially not in a public-facing clearance letter. These details would be contained within the full 510(k) submission, which is not publicly accessible in its entirety.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide answers to most of your specific questions (sample size, data provenance, expert details, adjudication, MRMC study, ground truth type, training set details) because this information is not present in the provided text.

The document mentions:

• Software verification and validation: "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements, and validation against user needs." This implies acceptance criteria were defined (as "defined requirements" and "user needs") and met, but the specific metrics and results are not listed.
• Hardware testing: "Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device (no changes have been applied to the Hardware)." Again, this confirms testing occurred and was successful, but the specific criteria and outcomes are omitted.

In summary, none of the specific data you requested (acceptance criteria, study details, sample sizes, expert qualifications, etc.) are available in the provided FDA 510(k) clearance letter.

To provide the information you're looking for, one would typically need access to the full 510(k) submission, specifically the V&V reports, which are proprietary and not released with the public clearance letter.

Ask a specific question about this device

Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

· Pin Placement Guides

The Materialise TKA Guides are 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 Guides 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides

The Materialise TKA Guides are 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 of the bone.

The Materialise TKA Guides must be used in conjunction with the 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.

• Models

The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software

The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

The Materialise TKA guide system is a medical device designed to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a pre-surgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.

The subject device is a system that consists of the following two functional components:

• l A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a pre-surgical TKA plan for a specific patient.
• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

The provided text from the FDA 510(k) summary (K221337) describes the Materialise TKA Guide System, but does not include detailed acceptance criteria or a study proving that the device meets specific performance criteria with quantitative results.

Instead, it relies on substantiating equivalency to a predicate device (K173445) and primarily focuses on verification and validation activities for the software, and re-evaluation/re-testing of hardware characteristics like biocompatibility, cleaning, sterilization, and packaging due to specific updates or extended specifications. It states that "Previous testing for debris, dimensional stability and packaging 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."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor detailed information about specific studies to prove device performance against those criteria, as this information is not present in the provided document.

However, I can extract information about the studies and verification activities that were performed, based on the provided text, and address the points that can be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

• This information is NOT PRESENT in the provided document. The document does not specify quantitative acceptance criteria for the accuracy or performance of the TKA Guide System (e.g., specific angular deviation tolerances, linear accuracies, etc.) nor does it report specific performance metrics from a study that demonstrate the device meets such criteria. It generally states that "Testing verified that the accuracy and performance of the system is adequate to perform as intended" and that "the subject device is as safe, as effective, and performs as well as the predicate device."

2. Sample Size for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated for performance testing related to accuracy. The document mentions "All samples passed the cleaning test" and "All samples passed the sterilization test," but the number of samples is not specified.
• Data Provenance: Not specified for any performance testing. It is not clear if any in vivo or ex vivo testing of the device's accuracy was performed as part of this submission, or if it relies entirely on the predicate's performance claims. The document mentions "previous simulated surgeries using rapid prototyped bone models and previous cadaver testing are considered applicable to the subject device," implying that these were done for the predicate, not necessarily for the current submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is NOT PRESENT in the provided document. The document does not describe studies involving experts establishing ground truth for performance evaluation of the device's accuracy.

4. Adjudication Method for the Test Set:

• This information is NOT PRESENT in the provided document. No adjudication method is mentioned as there's no description of a study involving expert assessment of performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study is mentioned in the provided document. The document focuses on regulatory clearance based on substantial equivalence, not comparative effectiveness studies with human readers assisting with AI vs. without AI. The device is a planning software and physical guides, not an AI diagnostic tool involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• A "standalone" software verification and validation was performed. The document states, "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements, and validation against user needs." However, specific performance metrics from this standalone validation are not reported. The "human-in-the-loop" aspect for this device is the surgeon using the planning software and then using the physical guides in surgery. The software part itself is a planning tool, and its "standalone" performance would likely refer to its accuracy in generating measurements or plans, which is generally covered by its verification and validation.

7. Type of Ground Truth Used:

• For the software verification and validation, the ground truth would typically be established based on defined requirements and user needs (as stated in the document). For hardware re-evaluations:
  • Biocompatibility: ISO 10993-1:2018 standards (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).
  • Cleaning: "extended cleaning cycle specifications, including testing of both manual and automated cleaning cycle with both enzymatic and alkaline detergent on a new worst-case design." Ground truth would be cleanliness metrics, though not specified.
  • Sterilization: ISO 17665-1:2006 "overkill method." Ground truth would be sterility assurance level.
  • Packaging: ISO 11607-1:2019, ISTA 3A:2018, ASTM D4169-16. Ground truth would be packaging integrity after simulated distribution.

8. Sample Size for the Training Set:

• The document does NOT mention a training set in the context of machine learning or AI. The software described is a "planning tool" and does not appear to be an AI/ML algorithm that would undergo a distinct training phase.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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 of bone before cutting 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, and AGC® Complete Knee system, and Consensus 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 the following knee prostheses:

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, and AGC® Complete Knee system, and Consensus Knee System.

The Materialise TKA Guides must only be used in conjunction with the implants listed above. Consult the prosthesis labeling and instructions for use for specific patient indications, 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 describes a 510(k) premarket notification for the Materialise TKA Guide System. While it states that "non-clinical tests using saw bones" and "Cadaver testing" were performed to verify the system's adequacy and demonstrate equivalent product performance, it does not provide specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred and what is missing:

1. Table of acceptance criteria and reported device performance:

The document mentions "accuracy and performance of the system is adequate to perform as intended" and "demonstrated equivalent product performance as the existing predicate devices," but it does not specify what those performance metrics or their acceptance criteria are.

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified for "saw bones" or "cadaver testing."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were non-clinical, so human patient data provenance is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The term "ground truth" as typically used for AI/ML validation (e.g., expert consensus) is not directly applicable to the non-clinical hardware testing described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study is not mentioned. The studies described are non-clinical (saw bones, cadaver) rather than clinical studies involving human readers or decision-making.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document mentions "non-clinical tests using saw bones" and "Cadaver testing." These tests evaluate the physical guide's accuracy in transferring the surgical plan (generated by the software) to the bone. This represents a form of standalone performance evaluation for the physical guide's output accuracy based on the plan. However, the performance of the software algorithm itself in producing the initial plan is not detailed as a separate standalone study with specific metrics. The software is used "pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan," implying human-in-the-loop for the planning phase.

7. The type of ground truth used:

For the "saw bones" and "cadaver testing," the ground truth would likely be based on physical measurements of the actual cut/drill locations relative to the intended surgical plan. This is a form of physical measurement/dimensional accuracy rather than expert consensus, pathology, or outcomes data typically used for diagnostic or predictive AI.

8. The sample size for the training set:

The document describes the Materialise TKA Guide System, which involves software for pre-surgical planning and 3D printed surgical guides. It doesn't explicitly mention an AI/ML component with a separate "training set" in the context of a typical AI/ML development pipeline. The "Materialise TKA Planner" is software device, but its development methodology (e.g., machine learning training) is not detailed.

9. How the ground truth for the training set was established:

Not applicable, as a discrete training set and its ground truth establishment are not described for an AI/ML model.

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