Search Results

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'
• GLOBAL® APG+ Shoulder System (K052472)
• DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694)
• GLOBAL® STEPTECH® APG Shoulder System (K092122)
• INHANCE™ Anatomic Shoulder System (K202716)1
• INHANCE™ Reverse Shoulder System (K212737)
• INHANCE™ Hybrid Anatomic Glenoid Implant (K212933)
• INHANCE™ Reverse Glenoid Peripheral Posts (K221467)
• INHANCE Convertible Glenoid (K230831)
• · Enovis'2 (DJO)
• Reverse® Shoulder Prosthesis (K051075, K111629, K092873)
• Turon® Shoulder System (K080402)
• AltiVate™ Anatomic Shoulder System (K162024)
• AltiVate™ Anatomic Augmented Glenoid (K213387, K222592)
• AltiVate™ Reverse Glenoid (K233481)
• · Smith+Nephew's3
• Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)
• Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)
• AETOS Total Shoulder System (K220847, K230572)
• AETOS Reverse Shoulder System (K220847, K230572)
• · Lima's
• SMR™ Shoulder System (K100858)
• SMR™ Reverse Shoulder System (K110598)
• SMR™ Modular Glenoid (K113254) (K143256)
• SMR™ 3-Pegs Glenoid (K130642)
• SMR™ TT Metal Back Glenoid (K133349)
• SMR TM 40mm Glenosphere (K142139)
• SMR™ TT Augmented 360 Baseplate (K220792)
• SMR™ TT Hybrid Glenoid (K220792)
• PRIMA TT Glenoid (K222427)

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.

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.

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.

Ask a specific question about this device

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'
• GLOBAL® APG+ Shoulder System (K052472)
• DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694)
• GLOBAL® STEPTECH® APG Shoulder System (K092122)
• INHANCE™ Anatomic Shoulder System (K202716)1
• INHANCE™ Reverse Shoulder System (K212737)
• INHANCE Hybrid Anatomic Glenoid Implant (K212933)
• INHANCE Reverse Glenoid Peripheral Posts (K221467)
• Enovis'2 (DJO)
• Reverse® Shoulder Prosthesis (K051075, K111629, K092873)
• Turon® Shoulder System (K080402)
• AltiVate™ Anatomic Shoulder System (K162024)
• AltiVate™ Anatomic Augmented Glenoid (K213387)
• Smith+Nephew's3
• Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)
• Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)
• AETOS Total Shoulder System (K220847, K230572)
• AETOS Reverse Shoulder System (K220847, K230572)
• Lima's
• SMR™ Shoulder System (K100858)
• SMR™ Reverse Shoulder System (K110598)
• SMR™ Modular Glenoid (K113254) (K143256)
• SMR™ 3-Pegs Glenoid (K130642)
• SMR™ TT Metal Back Glenoid (K133349)
• SMR™ 40mm Glenosphere (K142139)
• SMR™ TT Augmented 360 Baseplate (K220792)
• SMR™ TT Hybrid Glenoid (K220792)
• PRIMA TT Glenoid (K222427)

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.

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.

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).

Ask a specific question about this device

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.

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.

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.

Ask a specific question about this device

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'
  • GLOBAL® APG+ Shoulder System (K052472)
  • DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694)
  • GLOBAL® STEPTECH® APG Shoulder System (K092122)
  • INHANCETM Anatomic Shoulder System (K202716)
  • INHANCE™ Reverse Shoulder System (K212737)
• DJO's
  • Reverse® Shoulder Prosthesis (K051075, K111629, K092873)
  • Turon® Shoulder System (K080402)
  • AltiVate™ Anatomic Shoulder System (K162024)
• Smith & Nephew's
  • Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)
  • Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)
• Lima's
  • SMRTM Shoulder System (K100858)
  • SMRTM Reverse Shoulder System (K110598)
  • SMRTM Modular Glenoid (K113254) (K143256)
  • SMR™ 3-Pegs Glenoid (K130642)
  • SMRTM TT Metal Back Glenoid (K133349)
  • SMR™ 40mm Glenosphere (K142139)
• Stryker's .
  • ReUnion RSA Reverse Shoulder System (K183039)
  • Reunion TSA Total Shoulder Arthroplasty System (K183039)

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.

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. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific quides 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.

I am sorry, but the provided text primarily consists of an FDA 510(k) clearance letter and summary for the Materialise Shoulder System. While it describes the device, its indications for use, and technological characteristics compared to a predicate device, crucial details regarding the acceptance criteria and the study proving the device meets those criteria (such as specific performance metrics, sample sizes for test sets, ground truth establishment, or clinical study designs like MRMC studies) are not present in the provided document.

The "Performance Data (non-clinical)" section briefly mentions software verification and validation, but it does not provide the specific "acceptance criteria" for performance or the details of the "study that proves the device meets the acceptance criteria" in the format requested. It mainly relies on demonstrating substantial equivalence to a predicate device based on similar technology and previous testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them using only the information given in the input text. The information required for the table and the detailed study description is simply not provided in this regulatory document.

Ask a specific question about this device

Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
• Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus (with Standard or Long Stems)
• Revisions of previously failed shoulder joint replacements

Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

The INHANCE™ SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.

The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).

The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).

The provided text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.

The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."

The non-clinical testing performed includes:

• Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
• Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
• Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
• Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Identical to previously cleared devices.
• Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
• Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
• MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
• Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.

These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.

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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuffshoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The Reverse Shoulder Prosthesis Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The Humeral Eccentric Reverse Metaphysis is a line extension to the Medacta Shoulder Reverse System (K170452) and it is compatible with the other Medacta cleared products: Humeral Reverse PE Liner (K170452), Humeral Diaphysis (K170452), Short Humeral Diaphysis (K180089), Long Humeral Diaphysis (K192967).

The Humeral Eccentric Reverse Metaphysis implant subject of this submission is comprised of the following size: Diameter= Ø37.5mm Offset= 3mm.

The Humeral Eccentric Reverse Metaphysis implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:

• Humeral Diaphysis Cemented; ●
• Humeral Diaphysis Cementless; ●
• Humeral Reverse Metaphysis; ●
• Humeral Reverse HC Liner (also referred to as PE Liner); ●
• Glenoid Baseplate - Pegged;
• Glenoid Baseplate - Threaded;
• . Glenosphere;
• . Lateralized Glenosphere
• Glenoid Polyaxial Locking Screw;
• Glenoid Polyaxial Non-Locking Screw; ●
• Reverse Metaphysis Screw; and ●
• Glenosphere Screw.

The Humeral Diaphysis and the Humeral Reverse Metaphysis (standard or eccentric) are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis (standard or eccentric).

The purpose of the current submission is to gain clearance for the Humeral Eccentric Reverse Metaphysis.

The main body of Humeral Eccentric Reverse Metaphysis is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.

The screw of the Reverse Metaphysis (standard or eccentric), packaged with main body, is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy, enhanced with Type-II anodization.

The document provided is a 510(k) premarket notification for a medical device (Humeral Eccentric Reverse Metaphysis). It concerns the regulatory approval process for a new medical device, demonstrating its substantial equivalence to existing devices. Therefore, it does not describe acceptance criteria for, or the results of, a study proving device performance in the way a clinical trial or AI/ML performance study would.

Instead, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements for demonstrating substantial equivalence to a predicate device. This is primarily done through non-clinical performance testing and comparison of technological characteristics.

Here's how to interpret the provided information based on the request:

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

The document doesn't provide a direct table of "acceptance criteria" and "reported device performance" in a quantitative sense as might be seen for diagnostic accuracy or clinical outcomes. Instead, the acceptance criteria are implicitly that the device performs mechanically and biologically comparably to the predicate devices and meets relevant mechanical standards.

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

• Sample Size for Test Set: For non-clinical (mechanical) testing, sample sizes are not explicitly stated in the summary, but such tests typically involve a specific number of components or assemblies required by the test standard (e.g., ISO, ASTM). The document refers to "written protocols with acceptance criteria that were based on standards," implying standard-mandated sample sizes were used.
• Data Provenance: Not applicable in the context of clinical data for this device submission. The data is from non-clinical laboratory mechanical and material tests performed to specific standards (e.g., ISO 5832-3:2016, European Pharmacopoeia §2.6.14, USP chapter ).

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 question is not applicable for this type of submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices or those involving interpretation of medical images/data. This device is a shoulder prosthesis, and its evaluation for regulatory clearance relies on engineering, material science, and mechanical testing, not expert consensus on clinical diagnoses or interpretations.

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

• This question is not applicable. Adjudication methods (like 2+1 physician review) are used in clinical studies, particularly for endpoints that require expert consensus or evaluation. This submission relies on non-clinical engineering and material testing, where the "ground truth" is determined by physical measurements and adherence to technical specifications and standards, not human consensus on clinical findings.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI/ML assistance for human readers (e.g., radiologists interpreting images). This device is a shoulder prosthesis, not a diagnostic tool, and its submission did not involve such studies.

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

• No, this is not applicable. A standalone performance evaluation (algorithm only) is relevant for AI/ML-driven diagnostic or analytical devices. This device is a mechanical implant; there is no algorithm involved in its direct function or evaluation for regulatory clearance.

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

• The "ground truth" for the non-clinical tests is based on engineering specifications, material standards, and benchmarked mechanical performance against established predicate devices and relevant ISO/USP standards. For example, the ground truth for a static torsion test is whether the device withstands specified forces without failure, as per the test protocol and standard acceptance criteria. For material composition, the ground truth is adherence to the chemical specifications of Ti-6Al-4V.

8. The sample size for the training set

• This question is not applicable. "Training set" refers to data used to train AI/ML models. This submission is for a mechanical orthopedic implant and does not involve AI/ML.

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

• This question is not applicable for the same reasons as #8.

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Hardware: The Materialise Glenoid Positioning System is 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.

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 glenoid 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 Glenoid Positioning Guide and Models.

Materialise Glenoid Positioning System is a patient-specific medical device that is designed to assist the surgeon in the placement of glenoid components.

This can be done by generating a pre-surgical plan or by generating a pre-surgical plan and manufacturing a patientspecific guide and models to transfer the 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.
• a hardware component, branded as the Materialise Glenoid Positioning System™ Guide and Models, which is 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 guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery. The Materialise Glenoid Positioning System Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Glenoid Positioning System Guide. A graft model can be delivered with the Materialise Glenoid Positioning System Guide.

The provided document (K190286) is a 510(k) Premarket Notification for the Materialise Glenoid Positioning System. This document describes the device, its intended use, and claims substantial equivalence to a predicate device (K172054). However, it does not contain the detailed acceptance criteria and the study results proving the device meets these criteria in the format requested.

The "Performance Data" section (page 5-6) explicitly states:
"Previous testing for biocompatibility, cleaning, 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. The stability of the device placement, surgical technique, intended use and functional elements of the same as that of the predicate Materialise Glenoid Positioning System K172054 and previously cleared devices K170893, K1536559, and therefore previous cadaver testing on previously cleared devices K153602 and K131559 is considered applicable to the subject device."

This statement indicates that performance testing was conducted, and its results were deemed adequate. However, the details of those tests, including specific acceptance criteria, reported performance values, sample sizes, ground truth establishment, expert qualifications, and adjudication methods, are not present in this document. The document primarily relies on demonstrating substantial equivalence to previously cleared devices and states that "previous cadaver testing on previously cleared devices K153602 and K131559 is considered applicable to the subject device." This suggests that the detailed study results might be found in the 510(k) submissions for those predicate devices, rather than being explicitly laid out in this current submission.

Therefore, I cannot populate the table or provide specific details for most of your questions based solely on the text provided in K190286. The document focuses on regulatory justification for substantial equivalence, not a detailed scientific report of device performance trials.

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The Materialise Glenoid Positioning System is 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 Glenoid Positioning System can be used in conjunction with Stryker's ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's AltiVate Anatomic Shoulder (K162024), Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873) and their respective components, and Lima's SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256) and their respective components and Depuy Synthes' GLOBAL® APG+ Shoulder System (K052472), the DELTA XTEND™ Reverse Shoulder System (K120174, K062250) and the GLOBAL® STEPTECH® APG Shoulder System (K092122) and their respective components.

The Materialise Glenoid Positioning System guide is single use only.

Materialise Glenoid Positioning Guides are patient-specific medical devices that are designed to assist the surgeon in the placement of glenoid components.

This can be done by generating a pre-surgical plan or by generating a pre-surgical plan and manufacturing patientspecific guides to transfer the plan to surgery. The device is a system composed of the following:

• a software component, branded as SurgiCase Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
• a hardware component, branded as the Materialise Glenoid Positioning System™ guide, which is a patient specific guide that is based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guides will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery. The guide is designed and manufactured to fit the anatomy of a specific patient.

The Materialise Glenoid Positioning Guides must only be used within the intended use of the compatible components.

The provided text describes the 510(k) premarket notification for the Materialise Glenoid Positioning System. It claims substantial equivalence to a predicate device (K153602) and mentions performance data from previous testing. However, it does not contain the detailed acceptance criteria or the study that directly proves the device meets specific acceptance criteria in terms of quantitative performance metrics.

The text states: "Previous testing for biocompatibility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate squivalence with the predicate 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 same as that of the predicate Materialise Glenoid Positioning System (K153602), and therefore previous cadaver testing on predicate device K153602 and previously cleared device K131559 (which is the predicate for K153602) is considered applicable to the subject device."

This indicates that some performance evaluation was done for the predicate devices, and that information is being leveraged for the current submission. However, the specific acceptance criteria (e.g., maximum allowable deviation, accuracy thresholds) and the results of a study against those criteria for the current device are not presented in this document.

Therefore, I cannot provide a complete answer to your request based solely on the provided text. I will, however, outline what information is available and explicitly state what is missing.

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

This information is not explicitly provided in the document. The text states: "Testing verified that the accuracy and performance of the system is adequate to perform as intended." This is a qualitative statement, not a quantitative table of acceptance criteria and performance against those criteria.

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 cadaver testing on predicate device K153602 and previously cleared device K131559".

• Sample size: Not specified.
• Data provenance: Cadaver testing. Country of origin not specified.
• Retrospective/Prospective: Not specified, but cadaver testing is typically prospective for the purpose of the study.

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

• MRMC study: Not mentioned. The device is a surgical instrument/guide, not typically an AI-driven image interpretation system that would involve "human readers" in the sense of diagnostic interpretation. It assists surgeons in positioning glenoid components based on preoperative planning.
• Effect size: Not applicable given the nature of the device and the lack of an MRMC study.

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

The device is a "patient specific guide that is based on a pre-surgical plan" and a "software component, branded as SurgiCase Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient." The "Materialise Glenoid Positioning System guides are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively, assisting the surgeon."

This indicates a human-in-the-loop process where a qualified surgeon inspects, fine-tunes, and approves the pre-surgical plan generated by the software. Therefore, a purely standalone algorithm-only performance as an output without human involvement is not the intended use model described. However, the accuracy of the output of the software (the surgical plan and subsequent guide design) would have been validated, which is essentially a standalone performance evaluation of the software component's mathematical and geometrical accuracy. The details of this validation are not in the document.

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

Given the "cadaver testing" and the nature of the device (positioning guide), the ground truth for measuring accuracy would likely be physical measurements against an intended planned position or anatomical landmark, potentially established by expert surgeons or precise measurement tools. However, the specific method of establishing this ground truth is not detailed in the document.

8. The sample size for the training set

The document describes premarket notification for a medical device that includes "a software component" for planning and "a hardware component" (patient-specific guide). It mentions "previous cadaver testing" which sounds more like a validation/testing stage rather than training for a machine learning model. If the software component involves machine learning or AI, the training set details are not provided. The text focuses on the device being "substantially equivalent" to a predicate, implying that much of the foundational validation comes from the predicate's testing.

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

As described in point 8, a "training set" in the context of machine learning is not explicitly mentioned, and thus how its ground truth was established is not provided. If the software uses algorithms that are not machine learning-based, then the concept of a training set as typically defined for AI may not apply. The emphasis is on the software generating a "pre-surgical plan" and its accuracy.

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The Global UNITE Shoulder System humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
   Hemi-shoulder replacement is also indicated for:
4. Ununited humeral head fractures
5. Avascular necrosis of the humeral head
6. Deformity and/or limited motion
   When used in a total shoulder replacement, the Global Unite implants are to be used with DePuy glenoids. The glenoids are for cemented use only.
   When well-fixed, the Global Unite humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. The Delta Xtend metaglene is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.

The subject devices expand the Global UNITE Shoulder System to include two additional cobalt-chrome alloy humeral heads that mate with existing Global UNITE epiphyseal bodies, as well as new porous-coated anatomic epiphyseal bodies made from titanium alloy that mate with existing Global UNITE humeral heads and stems. In the case of further deterioration of the joint or rotator cuff, the surgeon has the option to remove the Global UNITE anatomic epiphyseal component and replace it with a Delta Xtend Reverse (K120174) epiphyseal component for conversion to a reverse shoulder prosthesis without removing the well-fixed distal stem.

This document describes DePuy Global UNITE Shoulder System. As this is not an AI/ML device, the following information is not applicable:

• Acceptance criteria and device performance table
• Sample sizes for test set and training set
• Data provenance or ground truth establishment
• Number and qualification of experts
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance

The device underwent various non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. These tests, listed below, were performed according to FDA's Guidance for Industry and FDA Staff - Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis. Clinical data was not required for this device.

The performance tests included:

• Epiphysis Comparison
• Head Comparison
• Screw Comparison
• Test Rationale
• Fretting and Corrosion
• Torque Test to Failure for Screw Fastener
• Human Torque Test for Screw Fastener
• Fatigue Test for Complete Implant with Lower Torque
• Cadaver Test Report
• Implant Insertion Test

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The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The glenoid base plate is intended for cementless application with the addition of screws for fixation.
The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Integra TITAN Reverse Shoulder System is a modular shoulder prosthesis system. The humeral components consist of humeral stems, varying heights of reverse bodies, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and 4 peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations.

The provided document describes the Integra TITAN Reverse Shoulder System, a medical device. The information details nonclinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical or AI-assisted diagnostic context.

Therefore, the following information, as requested in the prompt, is not available in the provided text:

• A table of acceptance criteria and reported device performance (in a diagnostic context)
• Sample size used for the test set and data provenance (for diagnostic performance)
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• Effect size of human readers improving with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a diagnostic algorithm
• The sample size for the training set (for a diagnostic algorithm)
• How the ground truth for the training set was established (for a diagnostic algorithm)

However, I can extract information regarding the nonclinical performance testing that was conducted for the device. The document explicitly states: "Clinical performance data were not necessary to support substantial equivalence." This means no human clinical trials (as one might expect a diagnostic AI to undergo) were presented for this 510(k) submission.

Here's what can be extracted about the device's nonclinical performance:

Nonclinical Testing and Acceptance Criteria:

The Integra TITAN Reverse Shoulder System underwent several nonclinical performance tests to confirm its ability to perform under expected clinical conditions. The acceptance criteria for each test are implicitly met as the summary states the "System met all acceptance criteria" or "is acceptable" for each respective test.

Additional Notes:

• Sample Size (for nonclinical tests): The document does not specify the exact sample sizes (number of units tested) for each nonclinical test, but refers to "worst-case components or constructs" being tested.
• Data Provenance (for nonclinical tests): These are laboratory-based engineering tests, not clinical data from patients or a specific country.
• Ground Truth (for nonclinical tests): The ground truth for these tests is based on established engineering principles, biomechanical justification, industry standards (e.g., ASTM F2009-00(2011)), and FDA guidance documents.
• Training Set (for nonclinical tests): This concept does not apply to the nonclinical testing described. These are physical performance assessments against predefined engineering parameters.

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