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The Univers Revers CA humeral head and adapters are indicated for:
• salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed
humeral stem, to an anatomic hemi-shoulder replacement; or
• conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator
cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement
when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has
been implanted.
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 subject device is a line extension to the Arthrex Univers Revers CA Heads and Adapters cleared in
K151527. The subject device components are smaller and are made of the same materials (cobalt
chromium, titanium, and UHMWPE) as the predicate. The subject devices are designed for use with the
Arthrex implantable devices cleared in K221232, K230366, K161782, K142863 and K170414. The
subject devices are labeled with MRI conditional claims in accordance with Arthrex labeling cleared
under K230513.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study as the provided text does not contain information about an AI/ML device or software. The document is an FDA 510(k) clearance letter for a medical device called "Univers Revers CA Head and Adapter," which is a shoulder prosthesis. The performance data section refers to mechanical and biocompatibility testing, not AI/ML algorithm 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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The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.

The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.

The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.

The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.

The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

This document appears to be a 510(k) Summary for a medical device called the "Remedy® Shoulder Spacer." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study designed to meet specific acceptance criteria in the way one would for an AI/ML powered device.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it describes a physical orthopedic implant, not a software algorithm.

Below is an attempt to map the available information to the closest relevant categories, with explanations for why certain sections are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the concept of "acceptance criteria" for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not present. Instead, the document discusses performance testing designed to demonstrate safe and effective mechanical function and material properties, and equivalence to a predicate device. The "acceptance criteria" would be compliance with relevant standards and demonstration of properties comparable to the predicate.

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

This is not applicable for a physical device 510(k) submission in the context of diagnostic "test sets." The performance data is based on laboratory testing of the device itself and its components, according to established engineering and material science protocols. There is no biological "data" in the sense of patient images or clinical outcomes that would have "provenance."

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

This is not applicable. "Ground truth" in this context refers to a standard of truth for diagnostic or clinical outcome data, which is not evaluated here. The "truth" for device performance is established through physical and chemical testing against engineering standards and comparison to a predicate device.

4. Adjudication method for the test set

This is not applicable. There is no clinical "test set" requiring adjudication by experts.

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 is not applicable as this is not an AI/ML device or a diagnostic device involving "human readers."

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

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

This is not applicable in the AI/ML sense. The "ground truth" for the device's acceptable performance is defined by:

• Compliance with recognized standards: e.g., ISO for biocompatibility, sterilization standards.
• Engineering and material science principles: for mechanical strength, fatigue, material composition.
• Comparative data to a legally marketed predicate device: demonstrating that the new device is "substantially equivalent" in terms of safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical orthopedic implant.

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

This is not applicable as this is not an AI/ML device.

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The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, 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 for cemented fixation in the joint and must only be used with an appropriate bone cement.

The Arthrex Univers II Shoulder Pegged Glenoid is manufactured in three sizes from UHMWPE. The glenoid articular (lateral) surface is concave and articulates with the humeral head of the Univers or Univers II humeral stems. The fixation (medial) surface is convex and is designed with three pegs for cement interdigitation fixation.

The provided text describes the Arthrex Univers II Shoulder Pegged Glenoid, a shoulder prosthesis. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/ML performance.

This document is a 510(k) summary for a medical device (a shoulder prosthesis), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical or AI/ML study. The determination of substantial equivalence for a non-AI/ML device typically relies on a comparison of design, materials, manufacturing processes, and intended use with a legally marketed predicate device, rather than quantitative performance metrics from a specific study against acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states: "The Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the predicate Arthrex Univers Shoulder Prosthesis in which the basic features and intended uses are the same. Any differences between the Arthrex Univers II Shoulder Pegged Glenoid and the predicate Arthrex Univers Shoulder Prosthesis or Univers II Shoulder Prosthesis are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the currently marketed predicate device."

This indicates that the primary "proof" of meeting safety and effectiveness is through demonstrating substantial equivalence to an existing device, not through a new performance study with acceptance criteria as typically seen for AI/ML devices.

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