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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2016

Arthrex, Inc. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Blvd. Naples, Florida 34108-1945

Re: K161782

Trade/Device Name: Arthrex Univers Revers Shoulder Prosthesis System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD, PHX Dated: October 19, 2016 Received: October 20, 2016

Dear David L. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K161782

510(k) Number (if known)

Device Name Arthrex Univers Revers Shoulder Prosthesis System

Indications for Use (Describe)

(Humeral) Stems are intended for 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.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510K SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared	November 21, 2016
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	David L RogersProject Manager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@arthrex.com
Trade Name	Arthrex Univers Revers Shoulder Prosthesis System
Common Name	Shoulder Prosthesis
Product Code,	HSD – Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, CFR888.3690
Classification Name, CFR	PHX - Shoulder joint metal/polymer semi-constrained cemented prosthesis, CFR 888.3660
Predicate Device	K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System
Purpose of Submission	This traditional 510(k) premarket notification is submitted to obtain clearance for theArthrex Univers Revers Humeral Stems and Suture Cups as a line extension to the ArthrexUnivers Revers Shoulder Prosthesis System.
Device Description	The Arthrex Univers Revers Humeral Stems and Suture Cups is a line extension to theArthrex Univers Revers Shoulder Prosthesis System. The proposed humeral stems, sizes 6thru 15, are modified versions of the humeral stems cleared under K130129/K142863 andare designed to be shorter in medial to lateral width. The line extension also introduces asize 5 modular stem as well as modified versions of the Humeral Suture Cups.
Intended Use	The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuffdeficient glenohumeral joint with severe arthropathy or a previously failed joint replacementwith a gross rotator cuff deficiency. The patient's joint must be anatomically and structurallysuited to receive the selected implant(s), and a functional deltoid muscle is necessary to usethe device.
	The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revisiontotal shoulder replacement for the relief of pain and significant disability due to rotator cuffdeficiency.
	(Humeral) Stems are intended for cemented or cementless applications for use with ArthrexHumeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementlessuse with the addition of screws for fixation.
SubstantialEquivalence Summary	The Arthrex Univers Revers Humeral Stems and Suture Cups are substantially equivalent tothe predicate devices, in which the fundamental scientific technology and intended use arethe same. Any differences between the Arthrex Univers Revers Humeral Stems and SutureCups and the predicate are considered minor and do not raise questions concerning safetyand effectiveness.
	Dynamic fatigue testing was performed to evaluate the fatigue resilience of the proposedUnivers Revers Humeral Stems and Humeral Suture Cups. All constructs survived 10 millioncycles for both compression and torsion loading conditions. Abrasion testing was alsoperformed to assess the risk of suture abrasion using the new Humeral Suture Cups.Abrasion resistance exceeded the predicate.
	Based on the indication for use, technological characteristics, and the summary of datasubmitted, Arthrex, Inc. has determined that the Arthrex Univers Revers Shoulder ProsthesisSystem is substantially equivalent to currently marketed predicate device.

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.