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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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The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
· Rheumatoid and other inflammatory arthritis

• · Correction of functional deformity, including fracture malunion
• · Humeral head fracture
• · Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

This document is a 510(k) summary for a medical device (AltiVate® Anatomic Shoulder AG e+™ with Markers), not a study report demonstrating device performance against specific acceptance criteria for AI/ML. Therefore, the information required to answer your specific questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies is not present in the provided text.

The closest relevant sections are:

• Mechanical and acoustic testing: "Dynamic evaluation of glenoid loosening or disassociation was performed per ASTM F2028-17." This refers to physical testing of the implant, not AI/ML performance.
• Clinical Studies: "Clinical data was not required." This explicitly states that clinical studies (which would involve human or AI/ML performance data) were not performed for this 510(k) submission.

Since the provided text does not describe an AI/ML device or its performance evaluation, I cannot generate the table or provide details about sample sizes, ground truth establishment, or expert involvement in such a study.

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The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
  Both components of the Catalyst CSR Shoulder System are intended for cemented use only.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
This submission adds 3 peg glenoids to the CSR Shoulder System. The Catalyst CSR 3 peg glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone. Two versions of the 3 peg glenoid are available with the pegs angled at either 17 or 25 degrees.

The provided text is a 510(k) summary for the Catalyst CSR 3 Peg Glenoids, a shoulder prosthesis. It details the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device.

The document discusses non-clinical testing for the glenoid components (static lever-out, static torque-out, dynamic shear testing, and Bacterial Endotoxin Testing) and concludes that "the performance of the Catalyst CSR Shoulder System is adequate for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed results of these tests.

It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices." This means a clinical study to establish performance against acceptance criteria in a human population, or a comparative effectiveness study, was not performed for this submission.

Therefore, many of the requested sections regarding AI/ML device performance are not applicable based on the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Cannot be created. The document states that non-clinical tests (static lever-out, static torque-out, dynamic shear testing, bacterial endotoxin testing) were performed and indicated "adequate performance for its intended use." However, it does not provide specific quantitative acceptance criteria (e.g., minimum load for lever-out, maximum endotoxin level) nor does it report the specific performance values achieved by the device in these tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for clinical performance. Clinical testing was not deemed necessary. For the non-clinical tests, the sample sizes and data provenance are not detailed in this summary document.

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)

• Not applicable. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission.

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

• Not applicable. No clinical test set or adjudication 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. An MRMC comparative effectiveness study was not performed. This device is a shoulder prosthesis, not an AI/ML diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device (shoulder prosthesis), not an algorithm or AI.

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

• Not applicable. No clinical ground truth was established for this submission. The "ground truth" for the non-clinical tests would be the established engineering standards or physical properties being measured.

8. The sample size for the training set

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set.

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

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set or its associated ground truth establishment.

Summary of relevant information from the document related to "acceptance criteria" and "study":

The document focuses on establishing substantial equivalence to predicate devices for a shoulder prosthesis, rather than demonstrating performance against novel acceptance criteria in a clinical study.

Non-Clinical Testing:

• Tests Conducted:
  • Static lever-out
  • Static torque-out
  • Dynamic shear testing (per ASTM F2028-14)
  • Bacterial Endotoxin Testing
• Reported Performance: "The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use." (Specific quantitative results or formal acceptance criteria are not provided in this summary.)
• Bacterial Endotoxin: "endotoxin limit of 20EU/device was met." (This is the only explicit acceptance criterion given, and the device met it for the predicate component, with the new glenoids not creating a new worst case).
• Clinical Testing: Explicitly stated as "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices."

In essence, the "study" proving the device met "acceptance criteria" for this 510(k) was a set of non-clinical, mechanical, and biocompatibility tests intended to show that the new components perform similarly to the predicate devices and meet basic safety and performance requirements for the indicated use, without requiring new clinical 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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