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Hemi or Total Shoulder:

The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.

Reverse Shoulder:

The SEVIIN Fracture Shoulder is also indicated for fracture total shoulder arthroplasty (due to acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint) 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 SEVIIN Fracture Shoulder humeral stems are intended for cemented applications. The glenoid components are intended for cemented use (total shoulder arthroplasty) and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation (reverse arthroplasty).

The SEVIIN Fracture Shoulder is a hemi or total shoulder prosthesis designed for use in patients with acute fracture of the proximal humerus. The modularity of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder. Additionally, the SEVIIN Fracture Shoulder can be used with the SEVIIN Reverse shoulder for relief of pain or significant disability associated with a grossly deficient or non-repairable rotator cuff joint if necessary.

The Fracture Humeral Stems are manufactured from Ti-6Al-4V utanium alloy conforming to ASTM F136 and have a corundum blasted proximal surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. The device features an anatomical neck/shaft angle and a 6 degree taper to mate with humeral heads (hemi or total shoulder) or a humeral cup (reverse shoulder).

Five sizes of fracture stems are available: 8, 10, 12mm diameter x 120mm and 8 and 10mm diameter x 200mm with a polished and fluted distal stem.

The Fracture humeral stems can be used with the SEVIIN Total Shoulder Humeral Heads and Glenoids (K043346) in addition to SEVIIN Reverse Shoulder components (K120374).

This 510(k) summary explicitly states that no non-clinical or clinical testing was performed to demonstrate substantial equivalence for the SEVIIN Fracture Shoulder. Therefore, there are no acceptance criteria or study results to report in the format requested.

The device's substantial equivalence determination was based on the comparison of its intended use, indications, materials, sizes, and design to legally marketed predicate devices. The FDA concluded that the noted differences did not raise new types of safety and effectiveness questions or new technological issues.

In summary, none of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) is available because no studies were conducted.

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The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.

Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:

• Rheumatoid arthritis .
• Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) .
• Correction of functional deformity .
• Humeral head fractures . ●
• Traumatic arthritis .

The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.

The SEVIIN Surface Replacement Shoulder is a hemi or total shoulder prosthesis designed for use in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. Additionally, the SEVIIN Surface Replacement Shoulder can be revised to a longer stemmed total shoulder if necessary.

The Resurfacing Humeral Heads are manufactured from Co-Cr-Mo alloy conforming to ASTM F799 and have a polished spherical surface for atticulation. The inner surface of the humeral heads is coated with titanium plasma spray. Three sizes of humeral heads are available: 42mm, 48mm and 52mm diameter with a stem that is tapered and fluted to provide stability in the humerus.

The Surface Replacement humeral heads are compatible with the previously cleared SEVIIN Total Shoulder Glenoids (K043346) for total shoulder replacement.

1. Table of Acceptance Criteria and Reported Device Performance

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

No specific test set or clinical data was used for this 510(k) submission. The device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, not through a separate clinical test set.

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

Not applicable. No clinical test set requiring expert ground truth was utilized. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation based on the provided documentation and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not conducted as part of this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. The SEVIIN Surface Replacement Shoulder is a physical medical device (implant), not a software algorithm, and therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was established through a comparison to legally marketed predicate devices, specifically their established safety and effectiveness profiles, as well as the results of non-clinical (mechanical/torsional) testing of the device itself.

8. Sample Size for the Training Set

Not applicable. This is not a study involving a "training set" in the context of machine learning or AI.

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

Not applicable. There was no training set for an AI/ML algorithm.

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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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