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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.

Device Description

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.

AI/ML Overview

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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