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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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