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The Global UNITE Shoulder System humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:

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
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
   Hemi-shoulder replacement is also indicated for:
4. Ununited humeral head fractures
5. Avascular necrosis of the humeral head
6. Deformity and/or limited motion
   When used in a total shoulder replacement, the Global Unite implants are to be used with DePuy glenoids. The glenoids are for cemented use only.
   When well-fixed, the Global Unite humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. The Delta Xtend metaglene is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.

The subject devices expand the Global UNITE Shoulder System to include two additional cobalt-chrome alloy humeral heads that mate with existing Global UNITE epiphyseal bodies, as well as new porous-coated anatomic epiphyseal bodies made from titanium alloy that mate with existing Global UNITE humeral heads and stems. In the case of further deterioration of the joint or rotator cuff, the surgeon has the option to remove the Global UNITE anatomic epiphyseal component and replace it with a Delta Xtend Reverse (K120174) epiphyseal component for conversion to a reverse shoulder prosthesis without removing the well-fixed distal stem.

This document describes DePuy Global UNITE Shoulder System. As this is not an AI/ML device, the following information is not applicable:

• Acceptance criteria and device performance table
• Sample sizes for test set and training set
• Data provenance or ground truth establishment
• Number and qualification of experts
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance

The device underwent various non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. These tests, listed below, were performed according to FDA's Guidance for Industry and FDA Staff - Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis. Clinical data was not required for this device.

The performance tests included:

• Epiphysis Comparison
• Head Comparison
• Screw Comparison
• Test Rationale
• Fretting and Corrosion
• Torque Test to Failure for Screw Fastener
• Human Torque Test for Screw Fastener
• Fatigue Test for Complete Implant with Lower Torque
• Cadaver Test Report
• Implant Insertion Test

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The Global UNITE humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:

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
3. Other difficult clinical problems where shoulder arthrodesis or 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
3. Deformity and/or limited motion

When used in a total shoulder replacement, the Global UNITE implants are to be used with DePuy glenoids. The glenoids are for cemented use only.

When well-fixed, the Global UNITE humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. The Delta Xtend metaglene component is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.

The Global UNITE humeral stems, suture collars, epiphyseal components and humeral heads are intended for total shoulder or hemi-shoulder replacement.

The Global UNITE Shoulder System includes a two-piece stem design that provides the option to convert a primary fracture prosthesis to a reverse prosthesis, a suture collar, an epiphyseal component, and a humeral head. In the case of failed tuberosity healing, the surgeon will be able to remove the Global UNITE epiphyseal component and replace it with a Delta Xtend Reverse epiphyseal component without removing the well-fixed distal stem.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

It is important to note that this document does not describe the acceptance criteria and study that proves a software algorithm's performance for medical image analysis. Instead, the document is a 510(k) summary for a mechanical orthopedic implant device, specifically the DePuy Global UNITE Shoulder System. Therefore, the questions related to AI/algorithm performance, ground truth, expert adjudication, MRMC studies, and training set do not apply.

The document demonstrates the device's technical characteristics and performance through pre-clinical mechanical testing to establish substantial equivalence to predicate devices.

1. A table of acceptance criteria and the reported device performance

Since this is a mechanical device submission, the "acceptance criteria" are related to mechanical and material performance, as opposed to diagnostic accuracy metrics for software. The document lists the types of pre-clinical tests performed, implying that the device met the performance standards associated with these ASTM standards or equivalent internal protocols, thereby demonstrating substantial equivalence. The specific numerical acceptance criteria and reported results are not provided in this summary but would be detailed in the full 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the sample size for each performance test. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards or internal statistically valid protocols, often involving a small number of units (e.g., n=3 or n=5) for each test condition.
• Data Provenance: The data is generated from in vitro laboratory testing of the physical device components, performed by the manufacturer, Depuy (Ireland). It is not clinical data (retrospective or prospective) from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable. The "ground truth" for mechanical performance tests is established by physical measurement against engineering specifications and industry standards (e.g., ASTM F2009-00, ASTM F1378-05), not by expert human interpretation like in diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This question is not applicable. Adjudication methods are used for clinical or image-based studies where expert consensus is needed to establish ground truth. For mechanical testing, the "adjudication" is based on objective measurements and compliance with predetermined pass/fail criteria according to established engineering standards.

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

• This question is not applicable. This is not an AI-powered diagnostic device, but a surgical implant.

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

• This question is not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance is established by objective physical measurements against predefined engineering specifications and compliance with relevant ASTM (American Society for Testing and Materials) standards for orthopedic implants.

8. The sample size for the training set

• This question is not applicable. There is no "training set" for a mechanical orthopedic implant. The device design and manufacturing processes are informed by engineering principles and prior device experience, not machine learning training data.

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

• This question is not applicable. See the answer to #8.

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