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

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

The Arthrex Univers Revers Humeral Stems and Suture Cups is a line extension to the Arthrex Univers Revers Shoulder Prosthesis System. The proposed humeral stems, sizes 6 thru 15, are modified versions of the humeral stems cleared under K130129/K142863 and are designed to be shorter in medial to lateral width. The line extension also introduces a size 5 modular stem as well as modified versions of the Humeral Suture Cups.

The provided text is a 510(k) premarket notification for a medical device, specifically the "Arthrex Univers Revers Shoulder Prosthesis System." It details the device's indications for use, its substantial equivalence to a predicate device, and some testing performed. However, it does not describe an acceptance criterion in the context of device performance metrics or any study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device.

Therefore, I cannot provide the detailed information requested in the format of acceptance criteria and a study demonstrating device performance. This document pertains to regulatory clearance based on substantial equivalence to a predicate device, not a performance study against specific acceptance criteria for diagnostic accuracy or clinical efficacy in the way the request implies (e.g., sensitivity, specificity, or improvement with AI assistance).

Here's a breakdown of why and what information can be extracted:

Why the request cannot be fully fulfilled from the provided text:

• Acceptance Criteria & Reported Device Performance (Table): The document doesn't define quantitative acceptance criteria for clinical performance (e.g., success rates, pain reduction scores, range of motion improvement) for the new device. It states the device's intended use and then relies on demonstrating equivalency to a predicate device through non-clinical testing (fatigue and abrasion).
• Sample Size & Data Provenance (for test set): There is no test set described in terms of patients or images for clinical performance. The "test set" for the mechanical tests (fatigue and abrasion) would be the physical implants themselves, not a clinical data set.
• Number of Experts & Qualifications / Adjudication Method: These points are relevant to studies involving human interpretation or clinical endpoints, which are not described here.
• Multi-Reader Multi-Case (MRMC) Study / Effect Size: This is specific to diagnostic or AI-assisted devices and is not applicable here as the device is a prostheses system.
• Standalone Performance: This would be for a diagnostic algorithm, not a physical implant.
• Type of Ground Truth: Ground truth (pathology, outcomes data) usually applies to diagnostic accuracy studies. While outcomes data would eventually be collected on this prosthesis in a clinical setting, this document is for premarket clearance based on equivalence, not a clinical trial demonstrating new outcomes.
• Sample Size for Training Set / How Ground Truth was Established (for training set): These relate to machine learning model development, which is not applicable to a shoulder prosthesis.

What can be extracted from the document related to "acceptance" in a regulatory sense and "study":

The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence and meeting the performance of the predicate device through bench testing.

• Implicit Acceptance Criteria (for mechanical properties):

  • Survivability of dynamic fatigue testing for 10 million cycles for both compression and torsion loading conditions.
  • Abrasion resistance using the new Humeral Suture Cups that "exceeded the predicate."

• Study Proving Device Meets Implicit Acceptance Criteria:

  • Study Name: Dynamic fatigue testing and abrasion testing.
  • Reported Device Performance:
    • Dynamic Fatigue Testing: All constructs survived 10 million cycles for both compression and torsion loading conditions.
    • Abrasion Testing: Abrasion resistance exceeded the predicate.
  • Sample Size for Test Set: Not specified, but generally refers to the number of physical device constructs tested in the lab.
  • Data Provenance (Test Set): Not applicable in the clinical sense. These would be lab-generated test results.
  • Ground Truth: Not applicable in the clinical sense. The "ground truth" for these tests are the physical properties and failure points observed in a controlled lab environment.
  • Other points (Experts, Adjudication, MRMC, Standalone, Training Set): Not applicable to this type of regulatory submission and testing.

In summary, the provided text is a 510(k) clearance letter and summary, which focuses on regulatory equivalence and non-clinical bench testing for a physical implant, not a clinical performance study with acceptance criteria for patient outcomes or diagnostic performance.

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The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with 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 glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.

The Arthrex Univers Revers Shoulder Prosthesis System has an articular design that is inverted compared to traditional total shoulder prosthesis. The system is comprised of two main components; the Arthrex Univers Revers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis. The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stem and epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeral cup liner. The humeral stem and epiphysis are available uncoated or with CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, and titanium screws.

The provided document is a 510(k) summary for the Arthrex Univers Revers Shoulder Prosthesis System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a novel AI algorithm might. Therefore, many of the requested details about acceptance criteria, specific study design for device performance, ground truth establishment, expert involvement, and reader studies (MRMC, standalone AI) are not applicable to a 510(k) for a medical device like a shoulder prosthesis.

The core of a 510(k) submission is to show that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is typically done through a comparison of technological characteristics, materials, design, and often, mechanical testing.

Here's the information that can be extracted or deduced from the document, organized according to your request, with explanations for why certain aspects are not present in this context:

Acceptance Criteria and Device Performance for Arthrex Univers Revers Shoulder Prosthesis System (K130129)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) submission for a shoulder prosthesis. The "test set" here refers to the mechanical tests conducted on the device itself, not clinical data from patients. The number of samples for mechanical testing would be based on engineering standards and statistical requirements for device strength and durability specific to the tests performed (e.g., fatigue, static strength testing), but these numbers are not given in this summary.
• Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data originates from laboratory testing of the manufactured device components.

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

• Not applicable. "Ground truth" in this context would refer to the true state of a patient, which is not evaluated in a 510(k) for a medical implant like this. The "truth" for mechanical testing is derived from controlled laboratory environments. The experts involved would be engineers and material scientists conducting the tests, but their specific numbers and qualifications are not part of this summary.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1 for clinical interpretations) are not relevant for mechanical testing of a medical implant.

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. This is a medical device (shoulder prosthesis), not an AI diagnostic or interpretive tool. Therefore, MRMC studies and AI-driven performance improvements are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Mechanical Performance: The "ground truth" is established through objective engineering measurements and standards for material properties, fatigue life, and static strength of the device components. This involves direct physical testing of the device under simulated physiological conditions.
• For Substantial Equivalence: The "ground truth" is a comparison against the characteristics and performance of the predicate devices, which have already been deemed safe and effective by the FDA.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

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

• Not applicable, as there is no "training set" for this type of device submission.

Summary of 510(k) Approach:

The key to this 510(k) submission is establishing "Substantial Equivalence" to predicate devices (K053274: Zimmer Anatomical Shoulder System; K100142: Torneir Aequalis Revers Shoulder Prosthesis). The manufacturer (Arthrex) demonstrated this through:

• Comparison of Intended Use.
• Comparison of Technological Characteristics (design, size ranges, materials, components).
• Submitted mechanical testing data to show equivalent fatigue strength, ensuring the device is adequate for its intended use.

The document explicitly states: "Clinical data and conclusions are not needed for this device." This confirms that no clinical patient studies involving "test sets," "ground truth" derived from patient outcomes, or expert adjudication of clinical data were part of this submission for market clearance.

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