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510(k) Data Aggregation

    K Number
    K242813
    Device Name
    Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    Manufacturer
    Materialise N.V.
    Date Cleared
    2024-10-18

    (30 days)

    Product Code
    QHE,KWS,PHX
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K052472,K120174,K062250,K183077,K203694,K092122,K202716,K212737,K212933,K221467,K230831,K051075,K111629,K092873,K080402,K162024,K213387,K222592,K233481,K100448,K112438,K142413,K152047,K130050,K161189,K173717,K181999,K220847,K230572,K100858,K110598,K113254,K143256,K130642,K133349,K142139,K220792,K222427,K233408,K231112,K230315,K220452,K212569,K193560,K172054,K170893,K153602,K131559,K241143
    Why did this record match?
    Reference Devices :

    K222592, K233481, K100448, K112438, K142413, K152047, K130050, K161189, K173717, K181999, K220847, K230572

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hardware:
    The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

    The Materialise Shoulder Guide and Models are single use only.

    The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

    Software:
    SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder 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 can be used as input data to design the Materialise Shoulder Guide and Models.

    Device Description

    Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following:

    • a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used . to generate a pre-surgical plan for a specific patient.
    • Materialise Shoulder Guide and Models, which are a patient-specific quide and models that are based ● on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patientspecific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.
    AI/ML Overview

    The provided FDA 510(k) summary (K242813) for the Materialise Shoulder System™ describes a submission seeking substantial equivalence to a previously cleared device (K241143). This submission is primarily for adding compatibility with new implant components rather than introducing a completely new AI capability or significant software change that would necessitate extensive new performance data. Therefore, the document does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML product.

    Specifically, the document states:

    • "The non-clinical performance data has demonstrated that the subject software technological differences between the subject and predicate devices do not raise any different questions of safety and effectiveness." (Page 9)
    • "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." (Page 10)
    • "Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject 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 device of Materialise Shoulder System™ K241143 and previously cleared devices... therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559 are considered applicable to the subject device." (Page 10)

    Given this, I cannot provide detailed answers to many of your questions as the submission relies on the substantial equivalence principle and prior testing rather than new, extensive performance studies for AI/ML.

    However, I can extract what is available:

    1. A table of acceptance criteria and the reported device performance

    The document does not provide a specific table of quantitative acceptance criteria and reported device performance for the current submission (K242813), as it relies on the previous clearance and the assessment that the changes (adding implant compatibility) do not raise new safety or effectiveness concerns.

    The general acceptance criterion mentioned is that the "accuracy and performance of the system is adequate to perform as intended." This was verified through previous testing, including "simulated surgeries using rapid prototyped bone models and previous cadaver testing."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The document mentions "previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559." It does not specify the sample size for these tests, nor the country of origin of the data or whether it was retrospective or prospective.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This information is not provided in the document.

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

    This information is not provided in the document.

    5. 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

    No such MRMC study is mentioned. The device is a "pre-surgical planner" and "surgical instrument" designed to assist the surgeon, but the provided text does not detail comparative effectiveness studies of human readers (surgeons) with and without the AI (planning software) assistance.

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

    The software (SurgiCase Shoulder Planner) generates a pre-surgical plan which the "qualified surgeon" can "visualize, measure, reconstruct, annotate, edit and approve" (Page 9). This indicates a human-in-the-loop process. Standalone performance of the algorithm without human interaction is not discussed as it's not the intended use.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    The document generally refers to "verification against defined requirements, and validation against user needs" and "accuracy and performance of the system is adequate to perform as intended" based on "simulated surgeries using rapid prototyped bone models and previous cadaver testing." This suggests a ground truth established through expert-defined surgical planning parameters and comparison to physical outcomes in the simulated/cadaveric environment, but specifics on how this ground truth was formalized (e.g., expert consensus on optimal planning, precise measurement validation) are not detailed.

    8. The sample size for the training set

    This device is a surgical planning tool and guides, not a deep learning AI model that requires a "training set" in the conventional sense for image classification or similar tasks. It is based on algorithms that process CT-imaging scans and anatomical landmarks to generate personalized plans and guides. Therefore, the concept of a "training set" for AI/ML is not applicable here in the way it would be for a pattern recognition AI. The software's robustness and accuracy are likely validated through extensive testing against various patient anatomies and surgical scenarios.

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

    As explained above, the concept of a training set as typically understood for AI/ML models is not directly applicable to this device based on the provided information.

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    K Number
    K241143
    Device Name
    Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    Manufacturer
    Materialise N.V.
    Date Cleared
    2024-05-22

    (27 days)

    Product Code
    QHE,KWS,PHX
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K052472,K120174,K062250,K183077,K203694,K092122,K202716,K212737,K212933,K221467,K051075,K111629,K092873,K080402,K162024,K213387,K100448,K112438,K142413,K152047,K130050,K161189,K173717,K181999,K220847,K230572,K100858,K110598,K113254,K143256,K130642,K133349,K142139,K220792,K222427,K233408
    Why did this record match?
    Reference Devices :

    K092873,K080402,K162024,K213387,K100448,K112438,K142413,K152047,K130050,K161189,K173717,K181999,K220847,K230572

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hardware:
    The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.
    The Materialise Shoulder Guide and Models are single use only.
    The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

    Software:
    SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder 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 can be used as input data to design the Materialise Shoulder Guide and Models.

    Device Description

    Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following:

    • a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
    • Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.
    AI/ML Overview

    The provided text describes a 510(k) submission for the Materialise Shoulder System™, Materialise Shoulder Guide and Models, and SurgiCase Shoulder Planner. It indicates that this is a special 510(k) submission, meaning it's for a modification to a previously cleared device. Therefore, much of the performance data refers back to the predicate device and prior clearances.

    Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state quantitative acceptance criteria or a direct table showing "acceptance criteria vs. reported device performance" for this specific 510(k) submission. Instead, for this special 510(k), the performance data mainly focuses on demonstrating that the changes (addition of new implant components to the software and hardware compatibility) do not raise new questions of safety and effectiveness compared to the predicate device.

    The "performance data (non-clinical)" section highlights that:

    • Hardware: Previous testing for biocompatibility, cleaning, debris, dimensional stability, and packaging is applicable. Accuracy and performance of the system were "adequate to perform as intended." Previous simulated surgeries and cadaver testing on earlier cleared devices are considered applicable.
    • Software: Software verification and validation were performed "against defined requirements" and "against user needs," following FDA guidance.

    Since this is a special 510(k) for an incremental change (adding compatibility with specific new implants), it's implied that the acceptance criteria are met if these additions do not negatively impact the established safety and effectiveness of the existing device, and the software development process meets regulatory standards.

    2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Hardware (previous testing cited): The document mentions "previous simulated surgeries using rapid prototyped bone models" and "previous cadaver testing on previously cleared devices K153602 and K131559." It does not specify the sample size for these previous studies (e.g., number of bone models or cadavers) or their provenance (country of origin), nor does it state if they were retrospective or prospective.
    • Software (verification and validation): The document states "Software verification and validation were performed," but does not specify a separate "test set" in the context of clinical data or specific performance metrics with sample sizes for this particular submission. The V&V activities would involve testing against requirements and user needs, which could include various test cases and scenarios, but these are not quantified here as a "test set" size.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This information is not provided in the document. The studies cited for hardware ("simulated surgeries" and "cadaver testing") and software ("verification and validation") do not detail the involvement of experts in establishing ground truth, their number, or specific qualifications. The software's function is to assist surgeons in planning, implying surgeon input in its use, but not explicitly in establishing a ground truth for a test set described in this submission.

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

    This information is not provided in the document.

    5. 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

    The document does not mention any MRMC comparative effectiveness studies. The device (SurgiCase Shoulder Planner software component and Materialise Shoulder Guide and Models hardware component) is designed to assist surgeons in planning and component positioning, but the provided text does not contain data on whether human readers/surgeons improve with or without this specific AI assistance or effect sizes.

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

    The document states that the SurgiCase Shoulder Planner is "intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components." It also mentions, "SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data." This indicates that the software is a human-in-the-loop device, where the surgeon is actively involved in the planning process and responsible for approving the plan. Therefore, a standalone (algorithm only) performance assessment, without human input, is unlikely to be the primary method of evaluation described or required for this type of device. The document does not provide such standalone performance data.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    The document does not explicitly state the type of ground truth used for any specific test set related to this submission. For the hardware (guides and models), the "accuracy and performance" implies a comparison to a known standard or ideal, perhaps derived from anatomical models or surgical goals. For the software, "verification against defined requirements, and validation against user needs" suggests that the ground truth for V&V would be the successful adherence to these requirements and user expectations, which could involve internal expert review or adherence to pre-defined medical/engineering specifications. However, specific types of ground truth like pathology or long-term outcomes data are not mentioned.

    8. The sample size for the training set

    This information is not provided in the document. As the submission is for a special 510(k) updating compatibility, it's possible that the core algorithms were developed and trained previously, and details of their original training are not part of this specific submission. The focus here is on the impact of the changes to the device.

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

    This information is not provided in the document. Similar to the training set size, the specifics of how the ground truth was established for the original training of any underlying algorithms are not included in this special 510(k).

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    K Number
    K233408
    Device Name
    Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    Manufacturer
    Materialise N.V.
    Date Cleared
    2023-11-09

    (34 days)

    Product Code
    QHE,KWS,PHX
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K052472,K120174,K062250,K183077,K203694,K092122,K202716,K212737,K051075,K111629,K092873,K080402,K162024,K213387,K100448,K112438,K142413,K152047,K130050,K161189,K173717,K181999,K220847,K230572,K100858,K110598,K113254,K143256,K130642,K133349,K142139,K220792,K183039,K220452,K212569,K193560,K190286,K172054,K170893,K153602,K131559,K231112
    Why did this record match?
    Reference Devices :

    K162024, K213387, K100448, K112438, K142413, K152047, K130050, K161189, K173717, K181999, K220847, K230572

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hardware: The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: DePuy Synthes', Enovis' (DJO), Smith+Nephew's, Lima's, Stryker's.

    Software: SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder 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 can be used as input data to design the Materialise Shoulder Guide and Models.

    Device Description

    Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following: a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient. Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.

    AI/ML Overview

    The provided text describes the regulatory clearance for the Materialise Shoulder System™ and mentions performance data, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

    The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a comprehensive standalone study with detailed effectiveness metrics.

    Here's an analysis of the information that can be extracted, and what is missing based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance:

    • Acceptance Criteria: Not explicitly stated in a quantitative manner for the performance of the AI component (SurgiCase Shoulder Planner) or the hardware (Materialise Shoulder Guide and Models) beyond ensuring it performs "as intended" and maintains accuracy.
    • Reported Device Performance: The document states that "Testing verified that the accuracy and performance of the system is adequate to perform as intended." However, no specific performance metrics (e.g., accuracy, precision, sensitivity, specificity, or error margins) are provided for either the software for planning or the hardware for guiding.

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

    • Test Set Sample Size: Not specified for the software component (SurgiCase Shoulder Planner).
    • Data Provenance: Not specified for any software testing.
    • For Hardware: It refers to "simulated surgeries using rapid prototyped bone models and previous cadaver testing." No specific number of models or cadavers is provided, nor is the country of origin or whether it was retrospective or prospective.

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

    • Number of Experts: Not specified.
    • Qualifications of Experts: Not specified.

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

    • Not specified.

    5. 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:

    • No MRMC study is mentioned. The document focuses on the planning and guidance aspect for surgeons, but not on a comparative study of human readers (surgeons) with and without AI assistance for diagnosis or planning accuracy.

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

    • A standalone performance evaluation of the software's planning functionality is implied through the statement "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.'" However, no specific metrics or study details are provided. The software is described as a "planning tool used to generate a pre-surgical plan" and for "assisting the surgeon in positioning shoulder components," suggesting a human-in-the-loop workflow.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Ground Truth Type: Not explicitly stated for the software. For the hardware, the use of "rapid prototyped bone models and previous cadaver testing" implies a physical ground truth for accuracy validation.

    8. The sample size for the training set:

    • The document does not mention a training set sample size, which is typical for AI/ML models. This suggests the software functionality described (planning, visualization, measurement) might not be based on deep learning/machine learning that requires explicit training data in the same way as, for example, an image classification algorithm. It seems to be a rules-based or physics-based planning software.

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

    • As no training set is mentioned, the method for establishing its ground truth is also not provided.

    In summary:

    The provided text from the FDA 510(k) summary states that non-clinical performance testing indicates the device is as safe and effective as its predicate. It mentions software verification and validation and previous hardware testing (biocompatibility, sterility, cleaning, debris, dimensional stability, packaging, simulated surgeries, cadaver testing). However, it lacks the specific quantitative acceptance criteria and detailed study results (such as sample sizes, expert qualifications, clear performance metrics, ground truth establishment for software, and formal comparative effectiveness study results) that are typically expected when describing a study proving specific acceptance criteria in detail. This information is usually found in separate, more detailed technical documentation submitted to the FDA, not in the public 510(k) summary.

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