. 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

Device Description

The Arthrex Univers Revers CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Arthrex Univers Revers CA Heads and Adapters." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness criteria. Therefore, the document does not contain information about acceptance criteria and a study to prove the device meets specific performance metrics in the way your request outlines for AI/software-based devices.

The information provided only discusses the substantial equivalence summary based on bench testing. Here's a breakdown of what is available and what is not in relation to your request:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail criteria for clinical performance in a typical sense for AI, but rather a demonstration of equivalence to predicates. The acceptance for this 510(k) submission is that the device's design, materials, and mechanical performance are comparable to cleared predicate devices and do not raise new questions of safety or effectiveness.
Reported Device Performance: The document states that in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) was performed and demonstrated that the performance of the proposed devices is "substantially equivalent to that of the predicate devices." No specific numerical performance metrics from these tests are provided, nor are the acceptance criteria for these mechanical tests detailed.

Table (based on available information, highly summarized):

Acceptance Criteria (Implied for 510(k))	Reported Device Performance
Mechanical performance not inferior to predicate devices.	In-vitro static loading, endurance, fretting corrosion, disengagement, torque-out tests demonstrated performance "substantially equivalent" to predicate devices.
Design, size range, and material consistent with intended use and predicates.	Device design, size range, and materials are comparable to predicates.

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

Test Set (for in-vitro mechanical testing): Not specified in this document. Since it's mechanical testing, the "sample size" would refer to the number of devices tested for each mechanical property.
Data Provenance: The nature of in-vitro testing suggests it's likely conducted in a lab setting, presumably by the manufacturer (Arthrex, Inc.). No country of origin is mentioned for the test data itself, but the manufacturer is based in Naples, Florida, USA. The testing is prospective in the sense that it's performed to support the 510(k) submission for this specific device.

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

Not applicable. This document describes mechanical testing of a physical implant, not clinical performance based on expert review or ground truth labeling like in an AI study.

4. Adjudication method for the test set:

Not applicable. This relates to clinical or interpretative studies, not mechanical bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study applies to diagnostic imaging or interpretation devices, typically AI-powered. The device in question is a physical orthopedic implant. The document explicitly states: "Clinical data and conclusions are not needed for this device."

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

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

7. The type of ground truth used:

Not applicable. For mechanical testing, the "ground truth" would be the measured physical properties against established engineering standards or predicate device performance.

8. The sample size for the training set:

Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning.

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

Not applicable. Again, no training set for a physical implant.

In summary: The provided document is a 510(k) clearance letter for a physical orthopedic implant, focusing on its substantial equivalence to previously cleared predicates through in-vitro mechanical testing. It does not contain the detailed performance criteria, clinical study designs, or AI-specific information requested.

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.

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

April 19, 2016

Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K151527

Trade/Device Name: Arthrex Univers Revers CA Heads and Adapters 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: March 9, 2016 Received: March 11, 2016

Dear Ms. Smith:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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" (21CFR 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 yours,

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

1.1 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151527

Device Name

Arthrex Univers Revers CA Heads and Adapters

Indications for Use (Describe)

The Arthrex Univers Revers CA Heads 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

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Date Summary Prepared April 12, 2016 Manufacturer/ Arthrex, Inc. Distributor/ 1370 Creekside Boulevard Sponsor Naples, FL 34108-1945 USA 510(k) Contact Courtney Smith Manager, Regulatory Affairs Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Telephone: 239/643.5553, ext.71720 Fax: 239/598.5508 Email: Courtney.Smith@Arthrex.com Trade Name Arthrex Univers Revers CA Heads and Adapters Common Name Shoulder Prosthesis Product Code, HSD - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, Classification Name, CFR CFR 888.3690 PHX - Shoulder joint metal/polymer semi-constrained cemented prosthesis, CFR 888.3660 Predicate Device Primary Predicate K130675: Arthrex Univers II CA Heads Reference Predicates: K130129 / 142863: Arthrex Univers Revers Prosthesis Shoulder System Purpose of Submission This traditional 510(k) premarket notification is submitted to obtain clearance for a line extension to the Arthrex Univers Revers Shoulder Prosthesis System. Device Description The Arthrex Univers Revers CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.

510K SUMMARY OF SAFETY AND EFFECTIVENESS 1.1

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Intended Use	The Arthrex Univers Revers CA Heads 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
SubstantialEquivalence Summary	The Arthrex Univers Revers CA Heads and Adapters is substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the Arthrex Univers Revers CA Heads and Adapters and the predicates are considered minor and do not raise questions concerning safety and effectiveness.The proposed devices are substantially equivalent to the predicate devices in regards to its intended use, design, size range, and material. The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Heads are available in 14 nominal sizes, and were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II CA Heads (K130675). The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes. The submitted in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) demonstrate that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Revers CA Heads and Adapters are adequate for their intended use. Clinical data and conclusions are not needed for this device.Based on the indication for use, technological characteristics, and the comparison to the predicate device, Arthrex, Inc. has determined that the Arthrex Univers Revers CA Heads and Adapters are substantially equivalent to currently marketed predicate devices.

Intended Use

The Arthrex Univers Revers CA Heads 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

SubstantialEquivalence Summary

The Arthrex Univers Revers CA Heads and Adapters is substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the Arthrex Univers Revers CA Heads and Adapters and the predicates are considered minor and do not raise questions concerning safety and effectiveness.The proposed devices are substantially equivalent to the predicate devices in regards to its intended use, design, size range, and material. The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Heads are available in 14 nominal sizes, and were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II CA Heads (K130675). The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes. The submitted in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) demonstrate that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Revers CA Heads and Adapters are adequate for their intended use. Clinical data and conclusions are not needed for this device.Based on the indication for use, technological characteristics, and the comparison to the predicate device, Arthrex, Inc. has determined that the Arthrex Univers Revers CA Heads and Adapters are substantially equivalent to currently marketed predicate devices.

Regulation Number and Section

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

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.