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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;
• cuff tear arthropathy (CTA Heads only).

The Large Resection Stems (not available in the US) are indicated for oncology applications.

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 and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

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

In the Anatomic shoulder the humeral construct consists of the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.

The SMR 40mm Glenosphere is a Co-Cr-Mo glenosphere intended to be used with the 40mm standard UHMWPE reverse liner (standard or retentive) as part of the SMR Reverse Shoulder System (K110598). The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems are provided for both cemented and cementless (K100858, K101263, K111212, K113523) fixation as well as reverse humeral bodies (K110598). The SMR Reverse Shoulder System metal back glenoids (K110598. K113254 and K133349) and glenospheres (K110598) are intended for uncemented pressfit use only with the addition of screws for fixation.

SMR 40mm Glenosphere is made of CoCrMo alloy that conforms to ASTM F1537 - ISO 5832-12 in two (2) different designs: a standard glenosphere that can be centered with respect to the glenoid component or eccentrical glenosphere that provides offset. Both designs have a spherical shape of 40mm diameter and articulate with the standard 40mm ultra-high molecular weight polyethylene (ASTM F648 - ISO 5834-2) liners that are coupled to the humeral body. Two designs for the 40mm liners are available: standard and retentive.

The 40mm glenospheres are coupled to a SMR metal-back glenoid (K113254, K133349) through a double male taper, one side of which is connected to the glenosphere while the other is coupled with the glenoid component. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. The screw is inserted through a hole on the surface of the glenosphere, passing through the internal cavity of the connector and then screwed to the metal-back.

The SMR 40mm Liners are made from standard ultra-high molecular weight polyethylene conforming to ASTM F648 – ISO 5834-2. They are coupled to the SMR Reverse Humeral Bodies (K110598) via a taper. The liners are designed with a bevel cut in their inferior aspect to reduce the possibility of accidental contact between the polyethylene liner and the scapular bone during adduction - abduction movements. The 40mm liners are available in standard and retentive designs in three (3) thicknesses (STD, +3mm and +6mm) with the retentive liners characterized by a deeper spherical concavity than is present in the standard liners.

The provided text is a 510(k) summary for the SMR 40mm Glenosphere. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical testing, rather than novel performance claims from a study. Therefore, most of the requested information regarding acceptance criteria and detailed study specifics (like sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies) is not present.

Here's what can be extracted and what is not provided based on the input:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of software or diagnostic device evaluations. Instead, it relies on demonstrating that the device meets the fatigue resistance requirements of the modular connection, and performs under expected clinical conditions, as evidenced by mechanical testing.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The text mentions "worst case components or constructs" were mechanically tested, but the number of units tested is not provided.
• Data Provenance: The testing was "Non-Clinical Testing" and involved "Mechanical testing." This implies laboratory-based physical testing of the device, not data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was mechanical testing of a medical implant, not a study requiring expert readers to establish ground truth on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is for studies involving human interpretation of data, which is not the case here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A MRMC study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR 40mm Glenosphere to the predicate devices."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable. The device is a physical implant, not an algorithm. The non-clinical testing performed can be considered a "standalone" evaluation of the device's mechanical properties, without a human-in-the-loop directly influencing its physical function during the test.

7. The type of ground truth used

The "ground truth" for the non-clinical testing would be the engineering specifications and failure criteria for fatigue resistance. The device either passed or failed the mechanical tests according to predefined engineering standards, implicitly demonstrating performance "under expected clinical conditions."

8. The sample size for the training set

Not applicable. The device is a physical implant, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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