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510(k) Data Aggregation
(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.
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(181 days)
The hardware: The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids and the Aequalis PerFORM + glenoids.
The software: The 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 BLUEPRINT3D planning software. BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the 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: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.
The hardware: The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and the Aequalis PerFORM + shoulder prostheses. The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.
The 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 (= total anatomic shoulder replacement). It is intended to help -plan an operation by allowing surgeons to: - position and select the glenoid implant, - design a patient specific pin guide.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Validation &/or Verification Method | Acceptance Value /Criteria | Reported Device Performance |
|---|---|---|
| Verify that the patient-specific solution is compatible with the instrumentation of Aequalis Perform+ in terms of technical, biological and clinical equivalences | Proven technical, biological and clinical equivalences | Acceptable |
| Compare post-operative clinical data with pre-operative plans to verify the accuracy of the patient-specific solution in Aequalis Perform+ configuration | Correct positioning of the main pin | Acceptable |
| Perform tests of software features when the Aequalis Perform+ is selected | No dysfunction of the software features and the Aequalis Perform+ is correctly displayed | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the "Compare post-operative clinical data with pre-operative plans" study. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies mentioned focus on the device's compatibility and accuracy rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes the "BLUEPRINT 3D planning software" as a "medical device for surgeon composed of one software component" intended to "assist in pre-operative surgical planning." This implies a human-in-the-loop scenario, where the software assists the surgeon. The study to "Perform tests of software features when the Aequalis PerFORM+ is selected" verifies the software's functionality and display, which seems to be a standalone test of the algorithm's output within the software environment. However, it's not a standalone performance study in the sense of the algorithm diagnosing or acting without human interpretation or intervention for clinical outcomes.
The "Compare post-operative clinical data with pre-operative plans" study indirectly assesses the software's effectiveness when used by surgeons, but it's still about the overall patient-specific solution, including the guide.
7. The Type of Ground Truth Used
For the study "Compare post-operative clinical data with pre-operative plans to verify the accuracy of the patient-specific solution in Aequalis PerFORM+ configuration", the ground truth is derived from post-operative clinical data, specifically assessing the "correct positioning of the main pin." This suggests an objective measurement from actual surgical outcomes.
For the other two validation methods, "technical, biological, and clinical equivalences" and "no dysfunction of the software features," the ground truth would be based on predefined technical specifications, biological assessments, and functional requirements of the software, as well as presumably expert review of the software's output.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set for the BLUEPRINT 3D planning software.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Since it is pre-surgical planning software, it's possible that historical CT-scans and corresponding surgical outcomes or expert annotations were used, but this is not specified.
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(102 days)
The hardware: The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The software: The 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, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the 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: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier. Tornier is the legal manufacturer for the hardware and the software.
The hardware: The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use. The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.
The 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 (= total anatomic shoulder replacement). It is intended to help to plan an operation by allowing surgeons to: position and select the glenoid implant, design a patient specific pin guide.
This submission seeks clearance for: Hardware: a guide made of Titanium with an orientation hole which allows for controlling rotation of the commercially available implant, AequalisTM PerFORM. Software modified to: Integrate a guide made of titanium, Add a glenoid sphere radius measurement.
The BLUEPRINT Patient Specific Instrumentation device's acceptance criteria and the study proving it are described below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Validation and/or Verification Method | Acceptance Criteria Description | Reported Device Performance |
|---|---|---|
| Patient Specific Guiding Wire test | Version angle error, inclination angle error, main (central) entry point error, and rotation entry point error must be compliant with device specifications | Acceptable |
| Dimensional test of the titanium guide | The titanium guide meets dimensional specifications | Acceptable |
2. Sample Size and Data Provenance:
- Sample Size: The document states that
studies using cadaver specimenswere used for non-clinical testing. However, the exact sample size (number of cadavers) is not specified. - Data Provenance: The cadaver studies were used for testing, implying prospective data collection for this specific validation. The country of origin of the data is not specified.
3. Number and Qualifications of Experts for Ground Truth:
- The document primarily focuses on validating the device's accuracy in guiding surgical procedures and meeting dimensional specifications. It does not explicitly mention the use of experts to establish a "ground truth" for a test set in the traditional sense of diagnostic AI performance. The ground truth for the "Patient Specific Guiding Wire test" would likely be derived from precise measurements taken during the cadaver studies, ensuring compliance with the device's design specifications. No information about expert qualifications or numbers is provided for this.
4. Adjudication Method for the Test Set:
- No adjudication method is mentioned. The "Acceptable" results for the non-clinical tests suggest that the measurements taken during the studies met predetermined specifications without requiring an adjudication process by multiple reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No information about a multi-reader multi-case (MRMC) comparative effectiveness study is provided. This device is primarily a surgical planning software and patient-specific instrumentation, not a diagnostic AI intended to assist human readers in image interpretation for improved diagnostic accuracy.
6. Standalone Performance Study:
- Yes, a standalone performance was done. The document outlines "Non-clinical testing" for
BLUEPRINT™ Patient Specific Instrumentationto "assess that no new safety or effectiveness questions were raised." This testing includes a "Patient Specific Guiding Wire test" and a "Dimensional test of The titanium guide," both of which evaluate the device's performance based on predefined acceptance criteria without human-in-the-loop performance described. The software's ability to measure in preoperative planning and generate a guide matching patient anatomy was validated using cadaver specimens.
7. Type of Ground Truth Used:
- The ground truth for the "Patient Specific Guiding Wire test" and "Dimensional test of The titanium guide" appears to be based on device specifications and direct physical measurements taken during cadaver specimen studies. For example, for the guiding wire test, the ground truth would be the ideal or intended version angle, inclination angle, and entry point, against which the device's actual performance is measured. Similarly, for the dimensional test, the ground truth is the specified dimensions of the titanium guide.
8. Sample Size for the Training Set:
- No information about a separate training set or its sample size is provided. The document outlines validation studies to assess the device's performance, but it does not detail the development or training of any machine learning components that would typically require a training set. The software mentioned is for pre-operative planning, visualization, measurement, and annotation, and the generation of a 3D file, which might not rely on machine learning in the same way a diagnostic AI would.
9. How the Ground Truth for the Training Set Was Established:
- Since there is no mention of a training set, there is no information provided on how its ground truth was established.
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(134 days)
The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The software
The 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 BLUEPRINT3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the 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: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software).
BLUEPRINT™ Patient Specific Instrumentation is the responsibility of Tornier including the Aequalis Glenoid Guides and BLUEPRINT 3D planning software. Tornier is the legal manufacturer for the hardware and the software.
The hardware
The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use.
The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.
The 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 (= total anatomic shoulder replacement).
It is intended to help to plan an operation by allowing surgeons to:
- position and to select the glenoid implant, ●
- design a patient specific pin guide.
The provided text describes BLUEPRINT™ Patient Specific Instrumentation, which consists of Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software. The hardware comprises patient-specific drill guides, and the software is a pre-surgical planner for shoulder orthopedic surgery.
The validation of this device was performed through non-clinical studies using cadaveric specimens or patient data. The summary outlines several validation tests and lists their acceptance criteria as "compliant" or "acceptable," but does not provide specific numerical thresholds for these criteria.
Here's the information requested based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Validation and/or Verification Method | Acceptance Criteria Description | Reported Device Performance |
|---|---|---|
| Seating validation Test | The seating offset between reference method and the software calculation should be compliant | Acceptable |
| Reaming validation Test | The Reaming offset between reference method and the software calculation should be compliant | Acceptable |
| Orientation and Direction angles Validation Test | The orientation angle offset and the Humeral Head Subluxation direction offset between reference method and the software calculation should be compliant | Acceptable |
| Glenoid Version and Inclination angle validation test | The version angle offset between reference method and the software calculation should be compliant. A concordance correlation coefficient ρ between the reference method and the software calculation of the inclination should be compliant. | Acceptable |
| Humeral Head subluxation and direction measure | The Humeral Head Subluxation offset and the Humeral Head Subluxation direction offset between reference method and the software calculation should be compliant | Acceptable |
| Patient Specific Guiding Wire test | Version angle error, inclination angle error and entry point error should be compliant | Acceptable |
| Segmentation Accuracy Test | Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant | Acceptable |
| Clinical Case Series | Pre-operative Plan compared to post-operative implant position | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "non-clinical studies performed on cadaveric specimen or performed by using patients' data" for validation. However, it does not specify the sample size for the cadaveric specimens or the patient data, nor does it explicitly state the country of origin or whether the patient data was retrospective or prospective. The "Clinical Case Series" also lacks specific sample size details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to "reference method" and "reference reconstruction" for ground truth but doesn't detail how these were established by experts.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI vs. without AI assistance. The testing described is primarily focused on the software's accuracy against a "reference method."
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study of the algorithm's performance appears to have been done. The "Validation and/or Verification Method" in the table explicitly refers to comparing "software calculation" or "3D reconstruction" to a "reference method/reconstruction," indicating that the algorithm's output was directly assessed without human intervention in the loop for those specific tests. The "Clinical Case Series" test involved comparing a "Pre-operative Plan" (generated by the software) to the "post-operative implant position," which also implies an assessment of the software's planning accuracy.
7. The Type of Ground Truth Used:
The ground truth used appears to be a "reference method" or "reference reconstruction" for the various validation tests. For the clinical case series, the ground truth was the "post-operative implant position." While the document implies these are established standards or measurements, it does not explicitly state whether this was expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
The document does not specify the sample size for the training set used for the BLUEPRINT 3D planning software. It only mentions that the studies used "cadaveric specimen or performed by using patients' data."
9. How the Ground Truth for the Training Set was Established:
The document does not provide information on how the ground truth for the training set was established. It describes validation testing but not the process of training the algorithm.
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