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510(k) Data Aggregation
(34 days)
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.
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(181 days)
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'
- DJO's
- Smith & Nephew's
- Lima's
- Stryker's .
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.
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(149 days)
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'
o GLOBAL® APG+ Shoulder System (K052472),
o DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694)
o GLOBAL® STEPTECH® APG Shoulder System (K092122)
o Ignite Anatomic Shoulder System (K202716) (rebranded to INHANCE™ Anatomic Shoulder System))
• DJO's
o Reverse® Shoulder Prosthesis (K051075, K111629, K092873),
o Turon® Shoulder System (K080402)
o AltiVate™ Anatomic Shoulder System (K162024)
· Smith & Nephew's (Integra's)2
o Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)
o Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)
• Lima's
o SMRTM Shoulder System (K100858),
o SMRTM Reverse Shoulder System (K110598),
o SMR™ Modular Glenoid (K113254) (K143256),
- o SMR™ 3-Pegs Glenoid (K130642),
o SMR™ TT Metal Back Glenoid (K133349), - o SMRTM 40mm Glenosphere (K142139).
· Stryker's
o ReUnion RSA Reverse Shoulder System (K183039)
o 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 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 serves as a visual reference for the surgeon in the OR.
The Materialise Shoulder Guide and Models must only be used within the intended use of the compatible components.
The provided text is a 510(k) summary from the FDA for a medical device called the "Materialise Shoulder System™". While it describes the device, its intended use, and states that non-clinical performance data indicates substantial equivalence to a predicate device, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving device performance.
Here's an analysis of what can be extracted and what is missing:
What's Available:
- Device Name: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- Purpose of the "Study": The document focuses on demonstrating substantial equivalence to a predicate device (K193560), rather than a specific clinical study with defined acceptance criteria for novel claims. The performance data presented are primarily non-clinical tests to support this substantial equivalence.
- Type of Ground Truth: For the "Hardware," it mentions "simulated surgeries using rapid prototyped bone models and previous cadaver testing." For the "Software," it mentions "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 implies validation against defined requirements and user needs, but not necessarily a clinical ground truth like pathology or outcomes data.
- Data Provenance (Implied): The company, Materialise N.V., is based in Belgium. The non-clinical tests mentioned would likely have been conducted by or for the manufacturer. The previous cadaver testing would likely have been retrospective or specifically for previous clearances.
What's Missing (and why based on the document type):
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. For this type of submission, extensive clinical studies with new acceptance criteria, expert adjudication, MRMC studies, or large training datasets for AI (if applicable, though this device seems more rule-based/software-assisted planning) are often not required if substantial equivalence can be demonstrated through non-clinical means and comparison to established predicate devices.
Therefore, the following information is not provided in the document:
- A table of acceptance criteria and the reported device performance: The document states that testing "verified that the accuracy and performance of the system is adequate to perform as intended" and that the subject device "is as safe, as effective, and performs as well as the predicate device," but it does
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