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The Univers Revers Shoulder Prosthesis System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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.

The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The subject devices are comprised of size 33 humeral suture-cups, spacers and inserts. The subject devices are made of either titanium or UHMWPE. The subject devices are smaller versions than those cleared in K161782 and K142863. The subject devices are compatible with the Univers Revers Shoulder Prosthesis System and Univers Revers Modular Glenoid System devices.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. Instead, it is a 510(k) premarket notification for a medical device called the "Univers Revers Humeral Cup Implant," which is a shoulder prosthesis.

The document discusses:

• Device Name: Univers Revers Humeral Cup Implant
• Manufacturer: Arthrex Inc.
• Regulatory Classification: Class II
• Product Codes: HSD, PHX
• Purpose of Submission: To obtain clearance for smaller size 33 humeral cup components for use with an already cleared shoulder prosthesis system.
• Technological Characteristics: The new components are made of the same materials (titanium or UHMWPE) as the predicates, have the same intended use/indications, packaging, shelf life, and sterilization. They simply expand the size range of cleared humeral implants.
• Performance Data: "Mechanical testing (i.e., PE liner/cup interface per ASTM F1820) was performed."
• Conclusion: The device is substantially equivalent to predicate devices, and mechanical testing demonstrates equivalent performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI/ML, as this document is about a mechanical orthopedic implant, not an AI/ML powered device.

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The Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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.

The Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The subject devices are augmented baseplates made of titanium with BioSync coating. The baseplates are available in sizes 24 and 28 with full and half augments. The subject devices are designed to be used cementless with peripheral screws and glenosphere devices cleared under K193372, K191960 and K173900.

This document is a 510(k) summary for the Univers Revers Modular Glenoid System, Standard Augment Baseplates. It does not contain information related to software performance or AI/ML acceptance criteria and studies.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on the mechanical and material equivalence of a medical implant (shoulder prosthesis) to previously cleared predicate devices. The "Performance Data" section specifically mentions:

• Mechanical testing: "Rocking horse testing per ASTM F2028 was performed to demonstrate that the subject device meets the standards requirements."
• Bacterial Endotoxin test: Conducted in accordance with various USP and EP standards.
• MRI testing: Conducted in accordance with FDA guidance and ASTM F2182.

These tests are standard for implantable hardware and are not related to artificial intelligence or machine learning performance.

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The Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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.

The Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The proposed devices are augmented modular glenoid baseplates made of titanium with BioSync coating. The proposed devices are half-wedge augmented modular glenoid baseplates available in two sizes (24 and 28). The baseplates are designed to be used cementless with peripheral screws and glenospheres (cleared under K193372 and K173900).

The provided document is a 510(k) summary for a medical device (Univers Revers Modular Glenoid System, Half Augment Baseplate). It focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, rather than presenting clinical study results for diagnostic accuracy or efficacy with human participants. Therefore, many of the requested criteria (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, and specific ground truth types like pathology or outcomes data) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract the acceptance criteria related to mechanical performance and the study that was performed to demonstrate that the device met these criteria.

Acceptance Criteria and Study for Univers Revers Modular Glenoid System, Half Augment Baseplate

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of human participant data, as this is a non-clinical submission for a Class II medical device. The studies mentioned are primarily benchtop or in-vitro tests:

• Mechanical Testing (ASTM F2028): The sample size for this testing is not explicitly mentioned but would typically involve multiple units of the device to ensure statistical robustness. The provenance is from laboratory testing.
• MRI Testing (FDA guidance and ASTM F2182): The sample size for this testing is not explicitly mentioned but involves the device itself. The provenance is from laboratory testing.

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

Not applicable. The studies performed are mechanical and MRI safety tests, not studies requiring expert clinical interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical findings.

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

No. An MRMC comparative effectiveness study was not done. This device is a shoulder prosthesis and the submission focuses on its physical and material properties, not diagnostic performance or human-AI interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant, not an algorithm or AI-based software.

7. Type of Ground Truth Used

The "ground truth" for the performance studies is based on established engineering standards and regulatory guidelines:

• Mechanical Performance: The "ground truth" is defined by the requirements of ASTM F2028, a recognized standard for testing glenoid component stability.
• MRI Safety: The "ground truth" is defined by FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and ASTM F2182, a standard for measuring RF-induced heating in MRI.

8. Sample Size for the Training Set

Not applicable. There is no training set in the context of this device and the presented performance data. This is not a machine learning or AI-based device.

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

Not applicable. There is no training set.

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