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.

Device Description

The proposed device is comprised of augmented modular glenoid baseplates and modular posts made of the same materials as the predicate (titanium/ BioSync). The baseplates are full wedge augmented versions of the cleared size 24 and size 28 modular baseplates. The posts are offered in lengths ranging from 20 mm to 40 mm. The proposed device is a line extension to the Univers Revers Modular Glenoid System was cleared under K173900.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Univers Revers Modular Glenoid System (Augmented baseplates)". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific clinical acceptance criteria in the manner one might find for a novel diagnostic AI algorithm.

However, I can extract the relevant information from a mechanical testing perspective, as this is the "performance data" provided for this specific device clearance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Requirement/Specification)	Reported Device Performance (Summary)
Mechanical Testing:
ASTM F2028: Rocking horse testing	Meets standards requirements (demonstrated equivalence)
ASTM F2009: Disengagement testing	Meets standards requirements (demonstrated equivalence)
Biocompatibility/Sterility:
ANSI/AAMI ST72:2011/(R)2016: Bacterial Endotoxin Test	Meets pyrogen limit specifications
USP <161>: Bacterial Endotoxin Test	Meets pyrogen limit specifications
USP <85>: Bacterial Endotoxin Test	Meets pyrogen limit specifications
EP 2.6.14: Bacterial Endotoxin Test	Meets pyrogen limit specifications
MRI Safety:
FDA guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment	Testing conducted in accordance with guidance
ASTM F2182: MRI Safety	Testing conducted in accordance with standard

Explanation: The document states that "Mechanical testing (i.e., Rocking horse testing per ASTM F2028, disengagement testing per ASTM F2009) was performed to demonstrate that the proposed device meets the standards requirements." It also states for endotoxin testing that it "demonstrate[s] that the proposed device meets pyrogen limit specifications," and for MRI that "MRI testing were conducted in accordance with FDA guidance ... and ASTM F2182." The implied acceptance criterion for each is meeting the respective standard/guidance's requirements or specifications, and the device is reported to have met them. The specific quantitative results of these tests and the exact "acceptance values" are not detailed in this summary document.

The subsequent points (2 through 9) primarily apply to studies involving AI algorithms or clinical trials with human readers and ground truth established by experts/pathology. This device, a modular glenoid system, is a physical implant, and its performance evaluation for 510(k) clearance is based on bench testing (mechanical, biocompatibility, MRI safety) and demonstration of substantial equivalence to a predicate device, not clinical performance studies with "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in the way an AI medical device would be evaluated.

Therefore, for aspects related to AI/diagnostic performance:

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples used in bench testing (e.g., glenoid components, constructs for mechanical testing). The provenance of these physical samples is the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and biocompatibility testing is established by the specifications of the ASTM, ANSI/AAMI, USP, and EP standards themselves.
Adjudication method for the test set: Not applicable. Testing against engineering standards does not typically involve human adjudication in the sense of consensus on diagnostic findings.
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 physical implant, not a diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation consists of the established engineering and biological safety standards (e.g., force limits, pyrogen limits, MRI artifact levels) against which the physical device samples were tested.
The sample size for the training set: Not applicable. This is a physical implant.
How the ground truth for the training set was established: Not applicable. This is a physical implant.

In summary: The provided document is for a medical implant and details bench testing results demonstrating adherence to established engineering and safety standards, rather than clinical performance data against diagnostic accuracy metrics. The entire submission aims to demonstrate substantial equivalence to a previously cleared device.

Summary

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January 10, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Ivette Galmez Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K193372

Trade/Device Name: Univers Revers Modular Glenoid System (Augmented baseplates) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX Dated: December 3, 2019 Received: December 5, 2019

Dear Ivette Galmez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K193372

Device Name

Univers Revers Modular Glenoid System (Augmented baseplates)

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared	December 2, 2019
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ivette GalmezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 71263Ivette.galmez@arthrex.com
Name of Device	Univers Revers Modular Glenoid System (Augmented baseplates)
Common Name	Shoulder Prosthesis
Product Code	PHX
Classification Name	21 CFR 888.3660: Prosthesis, Shoulder, semi-constrained metal/polymer, cemented
Regulatory Class	II
Predicate Device	K173900: Arthrex Univers Revers Modular Glenoid System
Reference Device	K142863: Arthrex Univers Revers Shoulder Prosthesis System
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain clearance foradditional modular baseplates and posts as a line extension to the Univers ReversModular Glenoid System cleared under K173900.
Device Description	The proposed device is comprised of augmented modular glenoid baseplates andmodular posts made of the same materials as the predicate (titanium/ BioSync). Thebaseplates are full wedge augmented versions of the cleared size 24 and size 28modular baseplates. The posts are offered in lengths ranging from 20 mm to 40 mm.The proposed device is a line extension to the Univers Revers Modular GlenoidSystem was cleared under K173900.
Indications for Use	The Univers Revers Modular Glenoid System is indicated for use in a grossly rotatorcuff deficient glenohumeral joint with severe arthropathy or a previously failed jointreplacement with a gross rotator cuff deficiency. The patient's joint must beanatomically and structurally suited to receive the selected implant(s), and afunctional deltoid muscle is necessary to use the device.The Univers Revers Modular Glenoid System is indicated for primary, fracture, orrevision total shoulder replacement for the relief of pain and significant disability dueto gross rotator cuff deficiency.The Univers Revers Modular Glenoid System is porous coated and is intended forcementless use with the addition of screws for fixation.
Performance Data	Mechanical testing (i.e. Rocking horse testing per ASTM F2028, disengagementtesting per ASTM F2009) was performed to demonstrate that the proposed devicemeets the standards requirements.Bacterial Endotoxin test was conducted in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 to demonstrate that theproposed device meets pyrogen limit specifications.MRI testing were conducted in accordance with FDA guidance Testing and LabelingMedical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTMF2182.
Conclusion	The Univers Revers Modular Glenoid System is substantially equivalent to thepredicate device in which the basic design features and intended use are the same.The mechanical testing data demonstrates that the proposed device performance isequivalent to the predicate device for the desired indications. Any differencesbetween the proposed device and the predicate device are considered minor and donot raise questions regarding safety or effectiveness.Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”