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Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for

• · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• · Avascular necrosis.
• · Conditions consequent to earlier operations.
• · Omarthrosis.
• · Rheumatoid arthritis.
• · Revision of shoulder prosthesis.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Reverse Application of the Anatomical Shoulder System
· The Anatomical Shoulder Inverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
· 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 Humeral Stems Cemented are intented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:

• · Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
• · Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the bead fragment
• · Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
• · Fracture instability after osteosynthesis of 3- and 4-part fragments of the proximal humerus
• · Posttraumatic necrosis of the humeral head
• · Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary o revision, total or hemi shoulder arthroplasty.
Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components.
The Anatomical Shoulder Domelock System consists of a Humeral Head which is connected to the Anatomical Shoulder humeral stems using an adjustable Domelock Dome centric including an Expansion Ball and Expansion-pin. The Domelock Dome is used to set the orientation of the Domelock Humeral Heads. The male oval cone taper of the Domelock expansion ball component is compatible with all Humeral Stems of the Anatomical Shoulder System.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System or with the Biomet Modular Hybrid or all-polyethylene Keeled Glenoid for total arthroplasty.

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device (Anatomical Shoulder Domelock Dome Centric) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria and detailing a study to prove they are met.

Here's why I cannot extract the requested information:

• No explicit acceptance criteria: The document does not list specific numerical or qualitative acceptance criteria for the device's performance. It describes modifications to an existing device to improve aspects like readability of a laser mark and ease of trialing, implying improvements but not setting quantified thresholds.
• No specific study proving criteria: The "Performance Data" section mentions "Functional relationship analysis" and "Finite Element Analysis for fatigue strength." These are analyses rather than comprehensive studies with defined test sets, ground truth, or statistical methods as you've requested.
• Emphasis on substantial equivalence: The core of a 510(k) submission is to show the new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparative technical characteristics and, in this case, a few minor design modifications, rather than a full-scale performance study against pre-defined acceptance criteria for a new type of device.
• No clinical data: The document explicitly states "Clinical data and conclusions were not needed to demonstrate substantial equivalence." This means there would be no human reader (MRMC) studies, standalone algorithm performance, or ground truth established from patient outcomes.

Therefore, your request for:

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

cannot be answered from the provided text. The document describes a physical medical device (shoulder prosthesis components), not an AI/software device that would typically have the kind of performance studies and ground truth establishment you are inquiring about.

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