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The ReUnion RFX System includes a Reversible Fracture Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.

When used with ReUnion TSA Humeral and Glenoid Components.

The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated 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, or posttraumatic arthritis.

• · Proximal humeral fractures and/or dislocation.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

· Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid glenoid provides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.

The glenoid components are intended for cemented use only.

When used with ReUnion RSA Humeral and Glenoid Components

The ReUnion RFX System, when used with ReUnion RSA humeral and glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

· Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;

• · Proximal humeral fractures
• · Revisions of previously failed shoulder joint replacements

In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.

The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).

• · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis.
• Proximal humeral fracture.
• · Revision of previously failed shoulder joint replacement.

Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.

The Humeral Stem components are intended for both cemented and cementless use.

In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.

In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator ouff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

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 posttraumatic arthritis.

• · Proximal humeral fracture and/or dislocation.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

· Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

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

In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.

1. ReUnion Reversible Fracture System (RFX)
   The ReUnion Reversible Fracture System consists of various length and diameter stems. The stems are made from Ti-6Al-4V according to ASTM F136 and have a Ti-plasma spray and hydroxyapatite (HA) coating on the proximal end of the shaft. The device contains various number of suture holes. The stems have a female taper on the proximal end of the shaft to accept TSA and RSA Gleno-humeral components. It is designed to be used in cemented applications only.

2. ReUnion Reverse Arthroplasty System (RSA)
   The ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a Humeral Cup, Humeral Insert, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.

3. ReUnion Total Shoulder Arthroplasty (TSA)
   The Reunion® Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular humeral neck adapter, single radius humeral heads, and self-pressurizing glenoids (SPG). The humeral stem will be manufactured from titanium alloy according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and be offered in 7mm-17mm distal diameters in Imm increments. The cemented humeral stems will have no coating at the proximal end and offered in 6mm-15mm distal diameters in lmm increments and includes 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed to mate with the subject single radius humeral 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 document is a 510(k) premarket notification for shoulder arthroplasty systems (ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical or standalone study.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not typically found in a 510(k) summary document for an orthopedic implant. The focus is on bench testing and material equivalence, not diagnostic accuracy or human performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in the typical sense of a diagnostic or AI device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, for an orthopedic implant, "performance" is demonstrated through compliance with recognized standards and material properties.

2. Sample Size for Test Set and Data Provenance:

• Test set sample size: Not applicable/not provided. This is an orthopedic implant, not a diagnostic device with a test set of data. The "tests" are bench tests on the device itself.
• Data Provenance: The document does not specify a country of origin for any "data" in the context of a dataset. The testing described is bench testing, which would typically be performed in a laboratory. It is a premarket notification, implying a prospective submission based on design and testing, not a retrospective analysis of existing clinical data.

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

Not applicable. Ground truth as it relates to expert consensus on medical images or diagnoses is not relevant for this type of submission. The "truth" for this device relates to its mechanical and material properties, and biocompatibility, which are verified through engineering and materials science standards.

4. Adjudication Method:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data (e.g., medical images). This is not relevant to the evaluation of an orthopedic implant.

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

No. This type of study assesses the impact of a diagnostic tool (like AI) on physician performance. The device in question is a physical orthopedic implant, not a diagnostic AI tool.

6. Standalone Performance Study:

No. A standalone study typically refers to the algorithm's performance without human intervention, again relevant for diagnostic AI. The "performance" of this device is evaluated through its mechanical properties and material composition against established standards, not through a standalone diagnostic accuracy study.

7. Type of Ground Truth Used:

The "ground truth" for this device primarily relies on:

• Engineering specifications and material properties: Conformance to ASTM standards for materials (e.g., Ti-6Al-4V according to ASTM F136; cobalt chrome according to ASTM F1537; X3® polyethylene according to ASTM F648).
• Bench testing results: Demonstrating mechanical integrity, compatibility in an MR environment (ASTM F2052, F2213, F2182, F2119), and pyrogenicity (ANSI/AAMI ST72:2011).
• Design and functional characteristics: Comparing the device's design and intended function to predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of medical device submission.

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