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The SEVIN Reverse Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral component is intended for cemented use and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation.

The SEVIIN Reverse Shoulder is a total shoulder prosthesis designed for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prostheses. The reverse shoulder is designed so that the "ball" of the articulation is on the glenoid side and the mating "cup" fits into the humeral stem. The components of the system include a Ti-6A1-4V alloy metaglene plate with titanium plasma spray coating, Ti-6Al-4V alloy bone screws, a Co-Cr-Mo alloy glenosphere, a Co-Cr-Mo alloy humeral cup and an ultra high molecular weight polyethylene (UHMWPE) inlay. These components are intended for use with the previously cleared SEVIIN humeral stems (cleared as the Genesis humeral stems).

The metaglene plate incorporates a cannulated cancellous central screw with cross holes and 4 peripheral screws for added stability. The screws have a 4.5mm diameter and are available in lengths of 24mm, 33mm and 42mm. The glenosphere mates with the metaglene plate via a taper lock and a glenosphere screw. The glenosphere is available in 36 and 40 mm diameter sizes with standard and +4 mm offsets.

The humeral cup mates with the humeral stem via a taper lock. The humeral cup is available in standard and +9 mm offsets. The proximal side of the humeral cup incorporates a snapfit mechanism and anti-rotation tabs that mate with the poly inlay. The poly inlay is a concave liner that is intended to articulate with the glenosphere proximally and attach to the humeral cup distally. The poly inlay is available in 36 mm diameters, centered and retentive, with 0, +3, and 6 mm offsets.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML or diagnostic performance. Instead, the document is a 510(k) premarket notification for a medical device called the "SEVIIN Reverse Shoulder" (K120374).

The document states:

• Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence of the SEVIIN Reverse Shoulder to the predicate devices." This means no clinical study was conducted for this specific device.
• Non-Clinical Testing: "Analysis of Range of Motion and testing of glenoid component fixation, assembly fatigue, humeral cup and poly inlay fixation and medical bone screw properties indicate that all components are adequate for their intended use." This refers to biomechanical and material testing rather than a study evaluating diagnostic performance or AI effectiveness.

Therefore, I cannot provide the requested information as it is not present in the given text. The questions about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the content provided.

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