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The SMR TT Metal Back Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system.

The SMR Anatomic Shoulder System is indicated for patients suffering from disability due to:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• · Inflammatory degenerative joint disease such as rheumatoid arthritis;
• · Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• · Revision of a failed primary implant;
• · Cuff tear arthropathy (CTA Heads):

When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid is intended for use with bone cement and should be used without bone screw.

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabling shoulder). 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. When used as part of the SMR Reverse Shoulder System, the SMR TT Metal Back Glenoid is intended for uncemented use with the addition of screws for fixation.

SMR TT Metal Back device described in this submission is identical to the device described in K133349. This submission includes an alternative surgical technique and surgical instruments to be used in combination with SMR TT Metal Back device, instruments and surgical technique described in K133349 in Reverse SMR Shoulder System configuration.

This FDA 510(k) premarket notification (K161120) for the SMR TT Metal Back Glenoid and Bone Graft Instruments does not describe a study that involves an AI/ML device. Therefore, the requested information cannot be extracted from this document.

The document is a submission for a shoulder joint prosthesis and associated instruments. It seeks to establish substantial equivalence to a previously cleared predicate device (K133349) by Limacorporate S.p.A. The key aspect of this submission revolves around an alternative surgical technique and surgical instruments for the existing SMR TT Metal Back device, particularly for use in the SMR Reverse Shoulder System.

It explicitly states on Page 5:

• "Non-clinical testing was not necessary to support the equivalence of the subject SMR TT Metal Back Glenoid to the device cleared in K133349."
• "LAL testing has been performed to establish the non-pyrogenicity of Limacorporate products."
• "Clinical testing was not necessary to support the equivalence of the SMR TT Metal Back Glenoid to the device cleared in K133349."

Since no studies related to AI/ML performance were conducted or are reported in this document, it is not possible to provide acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information for an AI/ML device.

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