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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.

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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, 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.

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