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The Reunion® TSA System components are sterile, single-use devices intended for use in primary and revision total shoulder arthroplasty to alleviate pain and restore function. The subject humeral stems will be offered in both cementless applications. The self pressurizing glenoid components are intended for cemented use only.

For use as a Hemi or Total Shoulder Replacement:

• Aseptic necrosis of the humeral head .
• Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
• Proximal humeral fractures and/or dislocation. .
• Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
• Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.

The gleonid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.

The subject Reunion® Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular neck adapter, single radius heads, and self pressurizing glenoids (SPG). The humeral stem components will be manufactured from titanium allov according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential plasma spray and hydroxyapatite (HA) coating and be offered in 7mm-17mm distal diameters in 1mm increments. The cemented humeral stems will be offered in 6mm-15mm distal diameters in 1mm increments and will also include 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed to mate with the subject single radius heads or the modular neck adapter, manufactured from cobalt chrome according to ASTM F1537, for compatibility with other marketed humeral heads. The single radius heads will be manufactured from cobalt chrome according to ASTM F75 and will be offered in spherical diameter head sizes 40mm-56mm in 4mm increments for both standard and eccentric designs. The self pressuring glenoids (SPG) will be manufactured from X3% polyethylene according to ASTM F648 and will mate with the single radius heads. The SPGs will be offered in both pegged and keeled configurations ranging from 40mm-56mm spherical diameters in 4mm increments.

The provided text describes a 510(k) premarket notification for the ReUnion® Total Shoulder Arthroplasty (TSA) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness through clinical trials with specific acceptance criteria that a device must meet.

Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics for a novel medical device are not applicable (N/A) or not provided in this document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: N/A (No clinical test set described in the 510(k) submission). Mechanical testing was performed. The specific number of samples for mechanical testing is not provided, only that it followed ASTM F2028-08.
• Data Provenance: N/A (No clinical data provided). Mechanical testing data would be from laboratory experiments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: N/A (No clinical test set or human-derived ground truth described).
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A (No clinical test set requiring human adjudication described).

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

• MRMC Study: No (Not applicable for a shoulder arthroplasty system. This type of study is typically for diagnostic imaging AI devices).
• Effect Size: N/A.

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

• Standalone Performance: N/A (The device is a physical shoulder implant, not a software algorithm or AI. The non-clinical testing refers to mechanical laboratory tests of the physical components).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Ground Truth: For the mechanical testing, the "ground truth" or standard was the performance requirements stipulated by ASTM F2028-08, demonstrating the device components' structural integrity and durability. For substantial equivalence, the "ground truth" is that the device's technological characteristics (material, design, sizes, and operational principles) are similar or identical to its predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: N/A (No AI algorithm or related training set described).

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

• Ground Truth for Training Set: N/A (No AI algorithm or related training set described).

Summary of the Study and Findings:

The study described is not a clinical study to establish new safety and effectiveness with defined clinical acceptance criteria. Instead, it is part of a 510(k) premarket notification process for a medical device (ReUnion® Total Shoulder Arthroplasty (TSA) System). The primary "study" components are:

• Non-Clinical Laboratory Testing: Mechanical tests were performed according to ASTM F2028-08. These tests included:
  • Fatigue strength on humeral components.
  • Dynamic evaluation of glenoid loosening on the glenoids.
  • The results demonstrated that the ReUnion® TSA system components met performance requirements and are considered "as safe and effective as their predicate devices" based on these mechanical properties.
• Basis for Substantial Equivalence: The submission asserts substantial equivalence based on the technological characteristics (material, design, sizes, and operational principles) being "similar or identical" to the listed predicate devices.
• Clinical Testing: None provided as a basis for substantial equivalence. The FDA concluded that the device is substantially equivalent based on the non-clinical testing and comparison to predicates.

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