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Total shoulder or hemi-shoulder replacement is indicated for:

• 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
• 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
• Other difficult clinical problems where shoulder arthrodesis or 3. resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

• 1. Ununited humeral head fractures.
• 2. Avascular necrosis of the humeral head.

The humeral stem is manufactured from titanium 6-Al-4V alloy and has a corundum blasted surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. There is a 6 degree male taper to mate with humeral heads. The devices features an anatomical neck/shaft angle. The humeral head is fabricated from cobalt chromium alloy. The head has a low profile and manufactured with a 6 degree taper to mate with the humeral stem. There are numerous head diameters to accommodate anatomical patient variations. An offset head at 4 mm is also available to permit soft tissue balancing and to enhance joint stability. The glenoid component is fabricated from ultra-high molecular-weight polyethylene. It is designed with a pear shaped frontal profile for anatomical fit to the glenoid which avoids soft tissue impingement. The articular surface radius of curvature is oversized to the humeral heads to accommodate multiple humeral head sizes. The device is designed with 3 peg fixation. The pegs are co-linear to help avoid punch through of thin cortical walls at the outer edges of the glenoid. The undersurface is keeled to enhance bone cement fixation.

This document describes a 510(k) summary for the Genesis Total Shoulder Replacement, a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data demonstrating device performance against granular acceptance criteria. Therefore, the provided text does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving their attainment.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. For 510(k) submissions, the “acceptance criteria” are primarily demonstrating substantial equivalence to a predicate device, as opposed to functional or performance metrics with specific thresholds that would be met by a clinical study. The document focuses on demonstrating that the Genesis Total Shoulder Replacement has "similar intended use, design intent, dimensions, surgical technique, materials, biocompatibility and labeling as that of predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document does not describe a "test set" in the context of a clinical study or a dataset for performance evaluation. The submission relies on technological characteristics and comparison to predicate devices, not on de novo clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. As there's no clinical study with a "test set" described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method

This information is not provided. Without a clinical study and ground truth establishment, adjudication methods are not applicable here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The document does not describe an MRMC study or any study comparing human readers with and without AI assistance. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This information is not provided. This device is a physical implant, not an algorithm, so a standalone performance study in that context is not applicable.

7. Type of Ground Truth Used

This information is not provided. There is no ground truth, in the typical sense of clinical study evaluation, mentioned in the document. The "truth" for this submission is the substantial equivalence to predicate devices already approved for market.

8. Sample Size for the Training Set

This information is not provided. The device is a physical implant; it does not involve machine learning algorithms that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As there's no training set, this question is not applicable.

Summary of Approach in the Document:

The provided document is a 510(k) summary for a medical device. The core of a 510(k) submission is to demonstrate substantial equivalence to one or more legally marketed predicate devices, not to establish new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for novel device performance.

The document states: "Substantial equivalence is derived from a composite of characteristics from multiple predicate devices including the Zimmer Select, the Biomet Bio-Modular total shoulder, Tornier Aequalis, the Global Total Shoulder and the Solar shoulder system."

It further elaborates on the basis of substantial equivalence: "The Genesis Total Shoulder replacement has similar intended use, design intent, dimensions, surgical technique, materials, biocompatibility and labeling as that of predicate devices. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues."

Therefore, the "acceptance criteria" for this submission are met by successfully arguing that the Genesis Total Shoulder Replacement is substantially equivalent to existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" is the comprehensive comparison presented in the 510(k) submission itself, demonstrating this substantial equivalence across various technical and functional aspects.

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