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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.

Blueprint® is a medical device for surgeons.

Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint® leads to the generation of a planning report.

Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if patient-specific instruments or Shoulder iD™ Primary Reversed Glenoid are available in your geography.

The Shoulder iD™ Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

· Rheumatoid arthritis

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

BLUEPRINT™ Patient Specific Instrumentation
Blueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software)

Blueprint™ Glenoid Guides
The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses.

The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software.

Blueprint™ Planning Software
Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and 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 to plan an operation by allowing surgeons to:

• · Plan for shoulder arthroplasty cases
• · Position and select glenoid and humeral implants,
• · Simulate the prosthetic range of motion,
• · Interact with implants and different computed measurements
• · Generate information required to design a patient-specific glenoid component when appropriate.

Shoulder iD™ Primary Reversed Glenoid
The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

This FDA 510(k) clearance letter and its accompanying summary focus on demonstrating substantial equivalence to predicate devices for two components: "Blueprint Patient-Specific Instrumentation" (software and hardware) and "Shoulder iD Primary Reversed Glenoid" (implant). The document primarily addresses the comparison of indications for use and technological characteristics, and broadly mentions performance testing.

Crucially, the provided text does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria in the format requested. The document mentions "performance testing" and "verification and validation evaluations" but does not elaborate on the specific metrics, results, or methodologies used.

Therefore, I cannot populate the table or answer most of the questions directly. However, I can extract what is implied or stated generally:

Implicit information from the FDA 510(k) context:

• Acceptance Criteria (Implied): For a 510(k) clearance, the primary acceptance criterion is substantial equivalence to existing legally marketed devices. This means demonstrating that the new device is as safe and effective as the predicate, and does not raise new questions of safety or effectiveness. For the software, this typically involves demonstrating accuracy, reliability, and functionality consistent with its intended use (pre-surgical planning). For the hardware (guides) and the implant, this involves demonstrating appropriate mechanical properties, fit, and biocompatibility.
• Study Type (Implied): Given it's a 510(k) without clinical studies, the studies would primarily be non-clinical performance testing (e.g., mechanical testing, dimensional accuracy, software verification and validation).

Here's what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing specific details:

• Quantitative acceptance thresholds (e.g., accuracy +/- X mm, specific mechanical test results).
• Detailed breakdown of results for each criterion.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified. The document mentions "cadaveric test" for the guides and "Non-clinical Reverse Glenoid Loosening testing" for the implant, but no sample sizes are given for these tests. For software verification and validation, typically a set of test cases is used, but the size or nature of these cases is not described.
• Data Provenance: The company (Stryker Corporation (Tornier, S.A.S.)) is based in France. The letter does not specify the country of origin of the test data. The studies are non-clinical (e.g., benchtop, cadaveric, software testing), not clinical trials on patients, therefore the retrospective/prospective distinction for patient data does not directly apply in the usual sense.

3. Number of Experts and Qualifications for Ground Truth:

• Not specified. Given that no clinical studies were performed, and the emphasis is on substantial equivalence through non-clinical testing and software V&V, the "ground truth" would likely be established through engineering specifications, validated simulation models, or anatomical measurements rather than expert clinical consensus on patient data.
• If expert review was involved in the software V&V or cadaveric studies (e.g., assessing anatomical landmark identification), their number and qualifications are not mentioned.

4. Adjudication Method for the Test Set:

• Not applicable / Not specified. Without details on how ground truth was established by experts on a test set (e.g., image annotations), an adjudication method cannot be inferred.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, not specified. The document explicitly states: "No clinical studies were performed." MRMC studies typically involve human readers interpreting medical images, usually in a clinical context, which wasn't part of this submission for demonstrating substantial equivalence. The device is a planning software and instrumentation, not primarily one for diagnostic interpretation by human readers.

6. Standalone (Algorithm-Only) Performance:

• Implicitly yes, for software verification and validation. The document states that "Technological differences between the subject and predicate software are supported with verification and validation evaluations." This suggests testing of the software's algorithms and functionalities independently. However, specific standalone performance metrics (e.g., accuracy of measurements, success rate of planning) are not detailed. The software is described as a "pre-surgical planner" that allows surgeons to "visualize, measure, reconstruct, and annotate anatomic data" and "design patient-specific components." The V&V would assess these capabilities.

7. Type of Ground Truth Used:

• For the hardware (guides): Likely dimensional measurements (engineering specifications) and anatomical landmarks/fit in cadaveric models.
• For the software: Likely engineering specifications, validated computational models, known anatomical dimensions from source CT data, and consistency checks against surgeon input/expectations during planning scenarios.
• For the implant: Mechanical testing standards and measurements (e.g., loosening, fatigue strength) compared against predicate performance.

8. Sample Size for the Training Set:

• Not specified. The document describes a "Blueprint Planning Software" but does not explicitly state it's an AI/machine learning model that requires a "training set" in the sense of supervised learning. It's described as software that allows surgeons to perform planning functions, implying it might be a rule-based system or an advanced visualization and measurement tool, rather than a learning algorithm. If there is an AI component, the training set size is not provided.

9. How the Ground Truth for the Training Set was Established:

• Not specified and not directly applicable unless the "Blueprint Planning Software" incorporates machine learning and has a distinct "training set." If it does, and assuming the software assists in identifying anatomical landmarks or making measurements, the ground truth for training data would typically be established by expert radiologists or orthopedic surgeons annotating CT scans.

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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® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific instruments and Tornier Perform patient-matched primary reversed glenoid*) based on the pre-surgical plan. Blueprint® leads to the generation of a planning report. Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and Blueprint® (software).

Hardware: The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.

Software: Blueprint® is a software connected to an Online Management System (OMS). The user interface software is 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 to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid components when appropriate.

The provided text is a 510(k) premarket notification for the BLUEPRINT™ Patient Specific Instrumentation, which includes both hardware (Glenoid Guides) and software (Blueprint®). While it describes the device, its intended use, and comparison to predicate devices, it does not contain the detailed performance data or acceptance criteria typically found in a study report.

Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study details. The document states that "Technological differences between the subject and predicate software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation." However, it does not present the results or specific criteria of these activities.

In the absence of a detailed study report within the provided text, I can only state that the document asserts that:

• Differences in design specifications do not raise different questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
• The subject device, the BLUEPRINT™ Patient Specific Instrumentation, does not raise new questions of safety or effectiveness.
• Differences in technological characteristics have been addressed by software verification and validation activities.

To answer your request, a more detailed study report or validation protocol would be necessary.

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Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator with pain disabled by: Rheumatoid arthritis, Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), Correction of functional deformity, Fractures of the humeral head, Traumatic arthritis, Revision of glenohumeral joint if sufficient native glenoid bone remains. All components are single use. The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.

BLUEPRINT™ Patient Specific Instrumentation:
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments 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.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgerv. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose. Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant (Patient-Matched Glenoid) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis. The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

BLUEPRINT™ Patient Specific Instrumentation: BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.
BLUEPRINT ™ Glenoid Guides: 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 only by the software BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is 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 to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid component when appropriate.

This document, K211359, is a 510(k) premarket notification for the Tornier Perform™ Patient-Matched Primary Reversed Glenoid (implant) and BLUEPRINT™ Patient Specific Instrumentation (hardware and software). The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through clinical trials. As such, the information provided focuses on non-clinical performance and verification/validation, largely relying on the predicate device's established safety and effectiveness.

Therefore, the following information, which typically applies to AI/software as a medical device (SaMD) clearances involving complex algorithms and clinical performance studies, is largely not present in this 510(k) summary. The provided text explicitly states that "No clinical studies were performed." This indicates that the device's performance was not evaluated through a study comparing it to an established ground truth in the way a traditional AI/SaMD clinical study would.

Here is a breakdown based on the provided document and the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for both the implant and the instrumentation. These are engineering/material specifications rather than clinical performance metrics for an AI algorithm.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance test for an AI algorithm. The tests described are non-clinical engineering/materials tests (e.g., pullout, fatigue). For the software, "verification and validation evaluations" were performed, but no specific number of cases or data provenance is detailed, as it's a conformity assessment to the predicate's operating principle.
• Data Provenance: Not applicable for an AI algorithm evaluation in this context. The document mentions "cadaveric test performed on the subject device" for the hardware, which would be test data, but not a "test set" in the sense of clinical images for an AI.

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

• Not applicable as no clinical study or AI algorithm evaluation with human expert ground truth was performed.

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

• Not applicable as no clinical study or AI algorithm evaluation with adjudicated ground truth was performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size on human reader improvement with AI assistance.

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

• For the BLUEPRINT™ 3D Planning Software, "verification and validation evaluations" were performed. While these evaluations assess the algorithm's functionality, they are not presented as a standalone performance study in a clinical context (e.g., measuring diagnostic accuracy against a ground truth dataset). The software is a planning tool, not a diagnostic AI.

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

• For the non-clinical tests (implant): Engineering specifications, material properties, and established consensus standards serve as the "ground truth" for the physical device's performance.
• For the software: The ground truth would be the accuracy and correctness of the planning outputs and measurements generated by the software, compared to expected or designed values. This is typically assessed through software verification and validation against a golden standard or internal reference data, not clinical ground truth like pathology or outcomes.

8. The sample size for the training set:

• Not applicable, as this is a 510(k) for an orthopedic implant and a planning software, not a deep learning AI model that requires a "training set" in the same sense. The software's design and programming are based on established anatomical and biomechanical principles.

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

• Not applicable, as no external "training set" with established ground truth, typical for AI model development, is mentioned.

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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 surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women only whose bone maturity is reached 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 IM Glenoid Guides are patient-specific instruments 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 only by the software BLUEPRINT™ 3D Planning Software.

Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is 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 to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Design a patient specific guide for the glenoid component when appropriate.

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Tornier SAS, indicating clearance for their BLUEPRINT™ Patient Specific Instrumentation.

It describes the device, its intended use, comparison to predicate devices, and a general statement about performance data and verification/validation testing. However, it does not detail:

1. Specific acceptance criteria values.
2. Reported device performance metrics.
3. Sample sizes for test or training sets.
4. Data provenance.
5. Number or qualifications of experts.
6. Adjudication methods.
7. MRMC study results or effect sizes.
8. Standalone algorithm performance.
9. Type of ground truth or how it was established for training/test sets.

The text states: "Technological differences between the subject and predicate software devices are supported with verification and validation evaluations. The operating principle of the subject device is the same as that of the predicate device." and "The differences in design specifications do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation testing." These are general statements about the testing performed, but no specific study details are provided.

Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text.

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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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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

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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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:

2. Sample Size and Data Provenance:

• Sample Size: The document states that studies using cadaver specimens were 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 Instrumentation to "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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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:

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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