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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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; in case of SMR Short Stems only if sufficient bone stock remains);
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

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 (disabled 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.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.

The SMR Shoulder System is a shoulder system. The SMR TT Hybrid Glenoid and the SMR 3-Pegs Cemented Glenoid are glenoid components intended to be used in combination with the previously cleared components of the SMR Shoulder System (humeral stems, humeral bodies, adaptor tapers, humeral heads) to achieve an anatomic configuration.

The purpose of the Special 510(k) is to add an alternative sterilization method for SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid.

The SMR TT Hybrid Glenoid is composed by a poly baseplate and a peg. The poly baseplate is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648) and Tantalum (ISO 13782 ASTM F560). The peg is manufactured from Ti6Al4V (ISO 5832-3 ASTM F1472).

The SMR 3-Pegs Cemented Glenoid is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648).

The SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid can be sterilized using a minimum gamma radiation dose of 25 kGy.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a shoulder implant system, the SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid.

It discusses the substantial equivalence of these devices to previously marketed predicate devices and mentions preclinical testing (sterilization validation, packaging validation, UHMWPE characterization).

Crucially, it explicitly states under "Clinical Testing: Clinical testing was not necessary to support substantial equivalence." This means no clinical study was performed or needed to demonstrate the device's performance against specific acceptance criteria in a human-in-the-loop or standalone AI context.

Therefore, I cannot extract the information you requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study and effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the clearance of a medical implant, not an AI/software device that would typically undergo the kind of performance evaluation you've described.

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