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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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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.

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 following total and reverse shoulder implant systems and their respective compatible components: the Reverse® Shoulder Prosthesis (K051075, K111629, K092873, K112069), the Turon® Shoulder System (K080402, K123982), and the AltiVate™ Anatomic Shoulder System (K162024), 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.

Software

Surgicase Planner is intended to be used as a pre-surgical planner for surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase 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.

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

The provided text describes the Materialise Glenoid Positioning System and its clearance by the FDA (K172054). However, it does not explicitly detail a separate study proving the device meets specific acceptance criteria with reported device performance metrics in a tabular format. Instead, it refers to previous testing and substantial equivalence to predicate devices.

Based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a table format with specific performance metrics. It generally mentions that "Testing verified that the accuracy and performance of the system is adequate to perform as intended." without providing quantitative values for accuracy or other performance measures.

Study Details

The document refers to prior testing, but not a specific new study with detailed methodology and results for the K172054 submission. Instead, it leverages the substantial equivalence to predicate devices and previously conducted cadaver testing.

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

   • Acceptance Criteria: Not explicitly stated with quantitative values in this document. The general criteria seem to be that "accuracy and performance of the system is adequate to perform as intended" and that it is "as safe, as effective, and performs as well as the predicates."
   • Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) are reported for this specific submission (K172054). The document relies on previous testing for predicate devices.

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

   • Sample Size: Not explicitly stated for a new test set. The document refers to "previous cadaver testing on previously cleared devices K153602 and K131559." The sample size for these previous cadaver tests is not provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The previous testing mentioned was "cadaver testing."

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

   • Not mentioned.

4. Adjudication method for the test set:

   • Not mentioned.

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 comparative effectiveness study is mentioned. This device is a surgical instrument and planning software, not an AI-assisted diagnostic tool for human readers in the typical sense.

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

   • This is partially addressed. The "Performance Data" section states, "Testing verified that the accuracy and performance of the system is adequate to perform as intended." This implies some level of standalone technical verification. However, no specific details on how this "accuracy and performance" was measured for the algorithm alone are provided, nor are any quantitative results. The software's function is to generate a pre-surgical plan, which is then inspected, fine-tuned, and approved by a qualified surgeon, indicating a human-in-the-loop process for clinical use.

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

   • The document implies that "previous cadaver testing" was used, which would typically involve physical measurements on cadaveric specimens, possibly treated as the ground truth for validating instrument placement accuracy. More specific details are not provided.

8. The sample size for the training set:

   • Not mentioned. The document primarily focuses on the device cleared under K172054 and its substantial equivalence, not on the training of its underlying algorithms (if applicable, beyond general software development).

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

   • Not mentioned.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing a new, comprehensive study with specific acceptance criteria and detailed performance results for the K172054 submission itself. It leverages prior testing and clearances.

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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.

Ask a specific question about this device

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 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.

The Materialise Glenoid Positioning System guide is single use only.

The Materialise Glenoid Positioning System™ consists of a software component, SurgiCase Planner and a hardware component, Materialise Glenoid Positioning System™ guide, and is designed to assist the surgeon in the placement of glenoid components.

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

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

The provided text describes the Materialise Glenoid Positioning System and its 510(k) submission for clearance. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly present a table of acceptance criteria with numerical targets. However, it implicitly states that the device was validated through non-clinical tests to ensure accuracy and performance, and demonstrate substantial equivalence to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." The text mentions "rapid prototyped bone models" and "cadaver testing." This suggests the test set consisted of physical models and cadavers rather than patient data.
• Data Provenance: Not specified regarding country of origin. The studies were non-clinical ("rapid prototyped bone models" and "cadaver testing"), implying they were experimental setups rather than retrospective or prospective patient data studies.

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

This information is not provided in the text. The documentation focuses on engineering and performance testing rather than assessment by clinical experts for ground truth. The "pre-surgical plan" is "fine-tuned and approved" by a "qualified surgeon," but this is part of the device's operational workflow, not the establishment of ground truth for its performance validation studies.

4. Adjudication Method for the Test Set

This information is not provided in the text. Given the nature of the validation (physical models and cadavers), adjudication by multiple experts in the traditional sense is unlikely to have been the primary method for determining accuracy. Accuracy would likely have been measured against pre-defined engineering tolerances or direct physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study described focuses on the device's accuracy and performance in a standalone context against a predicate, not on how it improves human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance evaluation was done. The text states: "Materialise Glenoid Positioning System was validated through non-clinical tests using rapid prototyped bone models to verify the system is adequate to perform as intended." This refers to evaluating the system's ability to precisely guide positioning against a pre-planned target, which is an assessment of the algorithm/system's accuracy. Cadaver testing also validates the device's performance in a more realistic surgical environment.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests likely involved pre-defined anatomical landmarks and surgical plans (for the rapid prototyped bone models) and cadaveric anatomy matched against the pre-surgical plan. The measurement of accuracy would be against the intended positioning based on these pre-established targets. It's not expert consensus, pathology, or outcomes data in the traditional sense, but rather a direct measurement against a known "correct" position derived from the surgical planning.

8. The Sample Size for the Training Set

The text does not mention a "training set" or any information related to machine learning model training. The device is described as a software component (SurgiCase Planner) and a hardware component (patient-specific guides) that creates pre-surgical plans and assists in intraoperative positioning. This suggests a rule-based or engineering-based design, not a machine learning model that requires a training set.

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

As no training set is mentioned (see point 8), this information is not applicable/provided.

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