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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 screws.

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 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.

The SMR II Metal Back Glenoid is nearly identical to the design of the SMR Modular Glenoid component cleared for use in anatomic shoulder replacement as part of the SMR Anatomic Shoulder System (K113254) and for use in reverse shoulder replacement as part of the SMR Reverse Shoulder System (K110598) except that the subject device is a 2-piece modular rather than a 1-piece design. The subject TT Metal Back Glenoid consists of two (2) components, a baseplate and a peg, that are coupled together and placed in the prepared glenoid cavity. When used as part of the SMR Anatomic Shoulder System (K113254), the subject SMR TT Metal Back Glenoid attaches to the SMR Anatomic Shoulder System's Modular Glenoid Liner component and is intended for use with bone cement. When used with the SMR Reverse Shoulder System (K110598), the subject SMR TT Metal Back Glenoid attaches to the SMR Reverse Shoulder Glenosphere component (K110598) and is intended for uncemented fixation, with additional fixation provided by bone screws. In the SMR Reverse Shoulder System application, the SMR TT Metal Back Glenoid is attached to the SMR Reverse Shoulder Glenosphere using the connectors cleared in K110598.

Baseplates are made from Ti6Al4V and are available in three sizes (Small-R, Small and Standard) while Pegs are manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3). Pegs are characterized by a conical coupling to allow the connection with baseplates. They present a Trabecular Titanium structure on the external surface.

Liners to be used coupled to SMR TT Metal Backs in anatomic constructs have been cleared via K113254.These devices are intended articulate with previously cleared SMR standard or CTA humeral heads (K110858 and K110847).

Bone screws, Glenospheres and connectors have been cleared via KI 10598.

The provided text describes a medical device, the SMR TT Metal Back Glenoid, and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. This document is an FDA 510(k) clearance letter and a Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Here's why the information is missing:

• Acceptance Criteria & Reported Performance: The document states that "Mechanical testing was performed on worst case components or constructs. The testing results demonstrated the device's ability to perform under expected clinical conditions." However, it does not specify what those "expected clinical conditions" are in quantifiable terms (i.e., acceptance criteria) nor does it provide specific "reported device performance" data (e.g., fatigue cycles survived, load at failure).
• Study Details: Since specific performance criteria and results are not provided, information regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details are also absent. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR TT Metal Back Glenoid to the predicate devices." This reinforces that the focus was on equivalence, not a direct performance study against defined criteria.

To fulfill your request, I would need a different type of document, such as a detailed test report, a clinical trial report, or a validation study that explicitly outlines performance metrics and acceptance thresholds.

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