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The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

• significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• united humeral head fractures of long duration;
• irreducible 3- and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head.
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
  The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid component is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid is a multi-pegged design and intended for cemented fixation only.

The provided text describes a 510(k) premarket notification for the Shoulder Innovations Total Shoulder System, which is an orthopedic implant. This document focuses on the substantial equivalence of the device to a predicate device based on non-clinical performance testing. It does not describe an AI/ML-driven device or study results that would typically include the requested information about acceptance criteria, sample sizes, ground truth establishment, expert involvement, or MRMC studies.

Therefore, most of the requested information regarding AI/ML device performance, human reader improvement, and ground truth types is not applicable to this document. The document refers to the following:

1. Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

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

• This information is not provided in the document as no clinical testing was performed. The testing was non-clinical (mechanical).

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

• This information is not applicable as ground truth related to clinical diagnosis or interpretation by experts is not relevant for the described non-clinical mechanical performance testing.

4. Adjudication method for the test set:

• This information is not applicable as there was no adjudication process for clinical data. The study involved non-clinical mechanical testing.

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, an MRMC comparative effectiveness study was not done. This document describes an orthopedic implant, not an AI-driven diagnostic or interpretative device.

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

• Not applicable. This document describes a physical orthopedic implant, not a standalone AI algorithm.

7. The type of ground truth used:

• For the non-clinical performance testing, the "ground truth" would be the physical properties and mechanical behavior of the device components as measured against the ASTM standards. This is not "expert consensus, pathology, or outcomes data."

8. The sample size for the training set:

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As there is no training set for a physical implant.

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