Search Results

The Aegualis Reversed Shoulder Prosthesis is indicated for patients, with a functional deltoid I ho requare to rever sou box replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aegualis Reversed Shoulder Prosthesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, infraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The humeral component:

The humeral part is made of 3 parts consisting of interchangeable stems, metaphysis , and inserts, that may be assembled in different configurations thus accommodating a large variation in patient size and anatomy.

The metaphyseal parts are fixed to the stem by a screwing fixation secured by a polyethylene breaking system. A lateralization spacer can be added to the humeral metaphysis in order to vary the lateralization.

The inserts are impacted on to the conic shape of the metaphysis. A polyethylene peg guides it in the correct position.

The stems are made of cobalt-chrome in 4 diameters The metaphyseal parts are manufactured from cobalt-chrome, in 2 sizes. The inserts are available in polyethylene in 6 sizes. The lateralization spacers are made of cobalt-chrome and are available in 2 sizes.

The glenoid component:

The glenoid part is composed of a base made of titanium alloy, on which is impacted a sphere of chrome cobalt. The assembly is secured by a central and internal screw. The sphere is available in two diameters congruent with the humeral insert.

The metallic base of the glenoid is fixed to the bone by using 4 compression screws for fixation.

The provided text is a 510(k) summary for the Tornier S.A. Aequalis Reversed Shoulder Prosthesis. It describes the device, its intended use, materials, and provides a substantial equivalence determination from the FDA. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication in the context of proving the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would fall under the categories requested in your prompt. The "Standards / Testing" section only lists material and sterilization standards, not performance criteria for the device's clinical efficacy or safety beyond material biocompatibility.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information is typically found in clinical study reports, scientific publications, or more detailed regulatory submissions (like a PMA) that are not part of this 510(k) summary.

Ask a specific question about this device