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The SMR Resurfacing Shoulder Prosthesis system is indicated for partial or total primary shoulder replacement in patients where the humeral head and neck have sufficient bone stock to support the prosthesis.

The Standard Resurfacing heads are indicated for partial or total shoulder replacement when the rotator cuff is intact or reconstructable. Specific indications include:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Post-traumatic osteoarthritis;
• Rheumatoid arthritis.

The CTA Resurfacing Heads are indicated for partial shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

• Rotator cuff tear arthropathy.

The humeral heads and stems are intended for uncemented use only. The glenoid components, used in total shoulder replacement, are intended for cemented use only.

The SMR Resurfacing Shoulder System consists of a humeral head, a humeral stem and an optional glenoid. The SMR Resurfacing Shoulder Prosthesis is intended for partial or total shoulder replacement. The heads and the stems are intended for uncemented use only. The glenoid components, used in total shoulder replacement, are intended for cemented use only. The glenoid components were previously cleared for use in the SMR Shoulder System in K100858.

Two versions of the SMR Resurfacing humeral heads are available: standard and CTA. Both versions have a spherical polished articulating surface with a plasma spray titanium coated inner surface. In the inner part of the head a male taper allows coupling with the humeral stem. The CTA version of the head is characterized by an extended articulating surface to keep the implant surface in contact with the acromion in patients with irreparable rotator cuff tear arthropathy. Eight sizes are available for the SMR Resurfacing standard heads (from 40 to 54mm diameter, increasing 2mm for each greater size): seven sizes are available for the SMR Resurfacing CTA heads (from 42 to 54mm diameter, increasing 2mm for each greater size). Heads are made from CoCrMo (ASTM F1537); the inner surface is plasma spray titanium coated (ASTM F1580).

The SMR Resurfacing humeral stem is characterized by a female taper for coupling with the resurfacing head. The external geometry of the stem has two taper angles and a fluted cross-section. The stem is externally sand-blasted. Two sizes of stems are available: 11 mm diameter (length 32 mm) and 13 mm diameter (length 36 mm). Stems are made from Ti6Al4V (ISO 5832-3 -- ASTM F1472).

The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.

The provided text describes the SMR Resurfacing Shoulder System, a medical device for shoulder replacement. It details the device's components, intended use, indications for use, and a comparison to predicate devices. The document also mentions non-clinical testing performed.

However, the document does not contain information regarding:

• Acceptance criteria in terms of specific performance thresholds (e.g., accuracy, sensitivity, specificity, or mechanical benchmarks with specific limits).
• A study that directly proves the device meets specific acceptance criteria in the format typically used for AI/ML device evaluations. The reported "non-clinical testing" section describes general testing categories (static disassembly, fatigue testing, torsional tests, ASTM standards) but does not provide details on specific acceptance criteria or the results against those criteria.
• Sample size for tests (other than implicitly in the non-clinical testing description, but no numbers are given).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Resurfacing Shoulder System to the predicate devices." This indicates that the regulatory clearance was primarily based on substantial equivalence to existing predicate devices and non-clinical engineering tests, rather than a clinical trial or AI/ML performance study as typically seen for devices with acceptance criteria measuring diagnostic accuracy or similar metrics.

In summary, based only on the provided text, it is not possible to answer the questions regarding acceptance criteria and study details as they are typically applied to AI/ML powered devices. The information pertains to a traditional orthopedic implant device, where "acceptance criteria" are usually met through engineering and material testing standards, and "proving the device meets acceptance criteria" involves demonstrating compliance with those standards and substantial equivalence to legally marketed predicate devices.

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