Search Results
Found 6 results
510(k) Data Aggregation
(30 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'
- 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
(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.
Ask a specific question about this device
(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.
Ask a specific question about this device
(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
Ask a specific question about this device
(147 days)
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.
Ask a specific question about this device
(140 days)
Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT™ 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINT™ 3D Planning Software. BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan. The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide. BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide. BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).
Hardware: The BLUEPRINT™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated by the BLUEPRINTTM 3D Planning Software. All BLUEPRINT™ Glenoid Guides are patient-specific, single use and delivered non-sterile.
Software: BLUEPRINT™ 3D Planning Software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help plan an operation by allowing surgeons to: Position and select glenoid implant, Position and select humeral implant, Display bone density and reaming surface, Simulate the prosthetic range of motion, Design a patient specific guide for the glenoid component.
The provided document is a 510(k) summary for the BLUEPRINT™ Patient Specific Instrumentation (K162800). It describes a medical device system composed of software (BLUEPRINT™ 3D Planning Software) and hardware (BLUEPRINT™ Glenoid Guides) used for pre-surgical planning and intraoperative guidance in shoulder arthroplasty procedures.
However, this document does not contain the specific details required to fully address all points in your request. It refers to previous 510(k) clearances (K143374 and K160555) for validation of the device, but it does not reproduce the detailed acceptance criteria and study results within this summary.
Based on the information available in this document, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This document does not explicitly state specific acceptance criteria (e.g., accuracy thresholds for guide placement) or detailed performance results in a table format. It broadly states that "The validation of BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was already proven via BLUEPRINT™ Patient Specific Instrumentation (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555), including polyamide and titanium materials... The performed testing for validation of the design, manufacturing, biocompatibility, sterility, dimensions and the accuracy of the guide are applicable to the subject device."
To obtain this information, one would need to access the full 510(k) submissions for K143374 and K160555.
2. Sample size used for the test set and the data provenance:
This document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to previous validations but does not provide details about those studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided 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:
This document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with/without AI assistance. The software is described as a pre-surgical planner to assist surgeons, implying it's a tool, but not explicitly tested in an MRMC setting for diagnostic performance comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the software as a "pre-surgical planner" and the guides as assisting in "intraoperative positioning." This implies a human-in-the-loop scenario where the software aids the surgeon. It does not describe a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This document does not specify the type of ground truth used for validation. It refers to "accuracy of the guide" being validated, which suggests comparison to a known standard, but the nature of that standard (e.g., CMM measurements, post-operative CT) is not detailed.
8. The sample size for the training set:
This document does not mention any training set size as it concerns the validation of an already proven system. If the AI component (the 3D Planning Software) involved machine learning, this information would typically be in its original clearance or a more detailed technical document.
9. How the ground truth for the training set was established:
As no training set is mentioned in this document, this information is not available.
In summary:
This 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed technical report of a new primary clinical validation study with all the requested specifics. To get the requested information, one would need to consult the original 510(k) submissions for K143374 and K160555, as these are the documents indicated as containing the previous validation data.
Ask a specific question about this device
Page 1 of 1