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Section 1: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Standard or Revision/Long Humeral Stem Implants
The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:

• · A severely painful and/or disabled ioint resulting from osteoarthritis or rheumatoid arthritis
• · Fracture 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
• · Irreducible 3- and 4-part fractures of the proximal humerus
• · Ununited humeral head fractures
• Avascular necrosis of the humeral head
• · Other difficult clinical problems where shoulder arthrodesis or not acceptable (e.g., revision of a failed primary component)
• Hemi-shoulder arthroplasty is also indicated for:
• · Deformity and/or limited motion
  The GLOBAL UNITE™ Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. 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. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:
  · Fracture 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
• · Irreducible 3- and 4-part fractures of the proximal humerus
  · Ununited humeral head fractures
  The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been developed to accommodate its use in a non-fracture press-fit application.
  GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty 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 must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE™ Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
  When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
  Section 2: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Short Humeral Stem Implants
  GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only. The GLOBAL UNITE Platform Shoulder System with Short Humeral Stem is intended for uncemented total or hemi-shoulder arthroplasty in treatment of the following:
• · A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
• · Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
• Hemi-shoulder arthroplasty is also indicated for:
• Deformity and/or limited motion
  GLOBAL UNITE Short Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty 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 to use the device.
  When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only.
  When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented use. GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only.

The Global Unite Platform Shoulder System is comprised of humeral stem, humeral head, suture collar and epiphyseal (anatomical or reverse) components. The subject Global Unite Short Stem is designed to conserve geometry and design features of the predicate Global Unite standard stem while eliminating the tapered distal stem body.

The provided text is a 510(k) premarket notification for a medical device (GLOBAL UNITE™ Platform Shoulder System). It does not describe any acceptance criteria or studies related to AI/algorithm performance. The "Testing Data" section explicitly states:

• Summary of clinical study: "Clinical study was not necessary."
• Summary of animal study: "Animal study was not necessary."
• Summary of non-clinical study: "Biocompatibility evaluation per ISO10993-1. Dimensional and geometrical equivalency analysis, fatigue strength evaluation, tolerance analysis and torque testing are conducted. MRI compatibility evaluation is conducted for MRI labeling."

This document focuses on establishing substantial equivalence to predicate devices based on design, materials, and mechanical testing, which is typical for implantable medical devices like shoulder prostheses. There is no mention of an AI/algorithm component requiring performance evaluation against an acceptance criterion.

Therefore, I cannot fulfill your request for the specific information regarding AI/algorithm acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or MRMC studies, as this information is not present in the provided document.

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Section 1: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Standard or Revision/Long Humeral Stem Implants
The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:

• · A severely painful and/or disabled ioint resulting from osteoarthritis or rheumatoid arthritis
• · Fracture 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
• · Irreducible 3- and 4-part fractures of the proximal humerus
• · Ununited humeral head fractures
• Avascular necrosis of the humeral head
• · Other difficult clinical problems where shoulder arthrodesis or not acceptable (e.g., revision of a failed primary component)
• Hemi-shoulder arthroplasty is also indicated for:
• Deformity and/or limited motion

The GLOBAL UNITE™ Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. 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. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:
· Fracture 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

• · Irreducible 3- and 4-part fractures of the proximal humerus
  · Ununited humeral head fractures

The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been developed to accommodate its use in a non-fracture press-fit application.

GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty 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 must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE™ Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.

When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.

Section 2: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Short Humeral Stem Implants
GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only. The GLOBAL UNITE Platform Shoulder System with Short Humeral Stem is intended for uncemented total or hemi-shoulder arthroplasty in treatment of the following:

• · A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
• · Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
• Hemi-shoulder arthroplasty is also indicated for:
• Deformity and/or limited motion

GLOBAL UNITE Short Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty 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 to use the device.

When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only.

When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented use. GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only.

The Global Unite Platform Shoulder System is comprised of humeral stem, humeral head, suture collar and epiphyseal (anatomical or reverse) components.
The subject Global Unite Short Stems are designed to conserve geometry and features of the predicate Global Unite standard stems while removing the distal segment of the stem body.

This is a 510(k) premarket notification for a medical device (GLOBAL UNITE™ Platform Shoulder System), which aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing safety and effectiveness through clinical studies with acceptance criteria, as would typically be done for novel devices or those undergoing PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance for a test set, expert qualifications, or adjudication methods for ground truth because no clinical evaluation of a diagnostic or AI algorithm is presented.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance results.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for training sets or how ground truth for training sets was established.

Instead, this submission primarily relies on non-clinical testing and evaluations (biocompatibility, dimensional/geometrical equivalency, fatigue strength, tolerance analysis, torque testing, and MRI compatibility) to demonstrate that the new device is as safe and effective as the predicate devices. The conclusion explicitly states: "The results of the non-clinical testing and evaluations have demonstrated that the subject device is as safe and effective as the predicate device and therefore, substantially equivalent to the predicate device."

The relevant "Testing Data" provided in the 510(k) Summary (page 7 of the document) are:

• Summary of non-clinical study: "Biocompatibility evaluation per ISO10993-1. Dimensional and geometrical equivalency analysis, fatigue strength evaluation, tolerance analysis and torque testing are conducted. MRI compatibility evaluation is conducted for MRI labeling."
• Summary of animal study: "Animal study was not necessary."
• Summary of clinical study: "Clinical study was not necessary."

This type of submission focuses on comparing the new device's technical characteristics and performance to existing, legally marketed devices through engineering and materials testing, rather than through clinical trials demonstrating diagnostic or therapeutic efficacy against a defined ground truth.

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The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:

• A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
• Fracture 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
• Irreducible 3- and 4-part fractures of the proximal humerus
• Ununited humeral head fractures
• Avascular necrosis of the humeral head
• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)

Hemi-shoulder arthroplasty is also indicated for:

• Deformity and/or limited motion

The GLOBAL UNITE Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. 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. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:

• Fracture 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
• Irreducible 3- and 4-part fractures of the proximal humerus
• Ununited humeral head fractures

The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been validated to accommodate its use in a non-fracture press-fit application.

GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty 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 must be anatomically and structurally suited to receive the reverse implant(s), and a functional deltoid muscle is necessary to use the device.

When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.

When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. GLOBAL UNITE humeral implants are for cemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.

The subject device expands the GLOBAL UNITE Platform Shoulder System (K101996, K133834) to include new porous-coated reverse fracture epiphyseal bodies made from titanium alloy that mate with existing GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stems. In fracture cases with a grossly rotator cuff deficient glenohumeral joint with severe arthropathy where a surgeon deems reverse shoulder arthroplasty appropriate, the surgeon can use a GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stem with the GLOBAL UNITE reverse fracture epiphysis and the DELTA XTEND metaglene and glenosphere (K062250).

The provided text is a 510(k) Summary for the GLOBAL UNITE Platform Shoulder System. It details non-clinical tests performed to demonstrate substantial equivalence to predicate devices, but explicitly states that no clinical testing was conducted. Therefore, it is not possible to describe acceptance criteria and a study proving a device meets them in the traditional sense of clinical performance or diagnostic accuracy.

However, I can extract the information related to the non-clinical acceptance criteria and the studies that demonstrate compliance with those engineering and material performance requirements.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a non-clinical submission, the "acceptance criteria" are implied by the nature of the tests (e.g., passing a fatigue test, demonstrating biocompatibility according to standards). The "reported device performance" is summarized as the device meeting these requirements to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified in the provided text. For non-clinical tests like fatigue or biocompatibility, samples would typically refer to the number of physical devices or components tested. The exact number is not detailed here.
• Data provenance: The tests were performed on the GLOBAL UNITE Shoulder System by DePuy Orthopaedics. Given the context of a 510(k) submission to the FDA in the US, the testing would typically be conducted under recognized standards, likely in a controlled laboratory environment. The origin of the data is from these internal and external laboratory tests, not from patient data from a specific country. The study explicitly states "No clinical testing was conducted." The tests are non-clinical in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not applicable. For non-clinical (e.g., mechanical, materials, biocompatibility) testing, "ground truth" is established by adherence to recognized engineering standards and measurement techniques, not by expert consensus on clinical findings.
• Qualifications of experts: Not applicable in the context of clinical ground truth establishment. The scientists and engineers performing and interpreting these technical tests would be qualified in their respective fields (e.g., mechanical engineering, materials science, toxicology).

4. Adjudication method for the test set:

• Adjudication method: Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical studies where multiple human readers assess data and discrepancies need to be resolved. For non-clinical engineering and material tests, compliance is determined by meeting predetermined specifications and 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:

• MRMC study: No. This is not applicable as the device is a shoulder implant and the submission is for non-clinical testing to demonstrate substantial equivalence, not for an AI/CADe system.

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

• Standalone study: No. This is not applicable as the device is a shoulder implant, not a software algorithm.

7. The type of ground truth used:

• Type of ground truth: Not applicable in the clinical or diagnostic sense for this submission. For these non-clinical tests, the "ground truth" is established by:
  • Engineering specifications and standards: e.g., ASTM standards for mechanical testing, ISO standards for biocompatibility.
  • Reference materials: For comparative tests like fretting corrosion.
  • Pre-defined pass/fail criteria: Based on these standards and specifications.

8. The sample size for the training set:

• Sample size for training set: Not applicable. The device is a physical medical implant, not an AI or machine learning algorithm that requires a training set.

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

• Ground truth for training set: Not applicable (see point 8).

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