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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 Augmented VaultLock Glenoid is indicated in replacement(s) when conditions include severe pain or significant disability resulting from degenerative, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed fixation in the joint and must only be used with appropriate bone cement.

The Augmented VaultLock Glenoid is made of the same materials as the predicate (UHMWPE). The Augmented VaultLock Glenoid is designed with a half-wedge augment. The proposed device has an identical spherical articulating surface as that of the previously cleared glenoids and is available in 4 nominal sizes. The proposed device is a line extension to the Arthrex VaultLock Glenoid cleared under K161108.

This document is a 510(k) premarket notification for the "Augmented VaultLock Glenoid" by Arthrex Inc. It is a medical device, specifically a shoulder prosthesis. The document mainly focuses on proving the substantial equivalence of the new device to existing predicate devices, rather than establishing acceptance criteria and proving performance through a standalone clinical study with specific metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and details on training sets for an AI device, are not applicable to this type of submission. This is a submission for a physical medical implant, not an AI or algorithmic diagnostic device.

The "Performance Data" section in the document refers to mechanical testing and biocompatibility testing, which are standard for physical implants, not clinical performance metrics in the way typically discussed for diagnostic algorithms.

Here's an attempt to fill in the table and address the questions based only on the provided text, recognizing that many fields will be "Not Applicable" for this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This submission describes mechanical and biocompatibility testing for a physical implant, not a clinical test set for an algorithmic device to establish diagnostic performance. The "tests" mentioned are physical and laboratory-based.

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)

• Not applicable. Ground truth establishment by experts is relevant for diagnostic algorithms or subjective clinical assessments. This submission focuses on engineering performance (mechanical strength, material safety).

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

• Not applicable. Adjudication methods are typically used for reconciling expert opinions in diagnostic studies. This is not a diagnostic study.

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

• Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a physical shoulder implant.

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

• Not applicable. This device is a physical medical implant, 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 based on engineering standards (e.g., ASTM F2028 for mechanical testing) and international standards for biocompatibility (e.g., ANSI/AAMI ST72). Compliance with these established industry standards serves as the benchmark for safety and performance in this context.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/algorithmic device for this physical implant.

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

• Not applicable. There is no "training set" for this physical implant.

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