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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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IN ANATOMIC:

The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Aequalis Ex2 is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the proximal humerus except for size 50mm(1)
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains except for size 50mm(1)

IN REVERSE:

The Aequalis Fx2 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 proximal humerus except for size 50mm(1

• Traumatic arthritis

• Revision of the devices if sufficient bone stock remains except for size 50mm( ).. The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.

The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the gleno-humeral articulation.

The Aequalis Fx2 consists of:

• in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads (K122698 ; K140082);

or

• in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants (K081059; K140478).

The Aequalis Fx2 is intended for use as:

• traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint,

including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,

• in case of bone defect in the proximal part of the humerus,

• a replacement of shoulder joints in primary anatomic or in primary reverse,

• a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

This submission corresponds to the design modification related to the Aequalis Fx2 assembly zone (humeral stems and reversed inserts) compatible only with each other. This design modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The pending humeral stems are compatible with the cleared Flex Shoulder humeral heads and the pending reversed inserts are compatible with the cleared Aequalis Reversed II glenoid implants. There is no change regarding the material of the pending Aequalis Fx2 humeral stems. The design change related to the pending Aequalis Fx2 reversed inserts does not include a titanium locking ring in contrast to the previously cleared Aequalis Fx2 reversed inserts.

Here's a breakdown of the acceptance criteria and the study information for the Aequalis Fx2 device based on the provided document:

This document is a 510(k) premarket notification for a medical device (Aequalis Fx2), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study on human-in-the-loop performance or diagnostic accuracy. Therefore, many of your requested points related to AI/algorithm performance (standalone performance, MRMC studies, ground truth establishment for training/test sets, expert qualifications) are not applicable to this type of submission.

The "study" described here consists of various engineering and physical tests to demonstrate that the modified device's performance is acceptable and comparable to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size in terms of units tested for each validation method. It refers to "the design modification" and "the pending Aequalis Fx2 humeral stem and reversed insert," implying that these tests were conducted on representative samples of the device components.
• Data Provenance: The tests are described as physical/bench tests conducted by the manufacturer, Tornier S.A.S., which is based in Montbonnot Saint-Martin, France. This is not patient-derived data; it's engineering test data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The "ground truth" for these engineering tests is established by industry standards, engineering specifications, and predicate device performance, not by medical experts interpreting data like in a diagnostic study.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations, which is not relevant to the physical testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable. This document is for a shoulder prosthesis and does not involve AI or human reader performance.

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

This information is not applicable. This document is for a physical medical device (shoulder prosthesis) and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these performance tests is based on:

• Engineering Specifications and Design Requirements: For dimensional comparisons, assembly methods, and convertibility.
• Predicate Device Performance: For tests like Pull-out and Torque testing, where the modified device's performance is compared for equivalence to previously cleared devices (K030941 and K141345).
• Failure Criteria: For fatigue testing ("No failure after the test").

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an engineering evaluation for a mechanical implant.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as above.

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