The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for significant disability resulting from degenerative, theumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures. comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures, of the humeral head, and fractures of the anatomical neck.

The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

Device Description

The fracture adapters are manufactured from Titanium with a hydroxyapatite (HA) coating and are offered in 10 sizes. The Fracture Adapters mate with a trunnion and FDA cleared Arthrex Humeral Stems and Heads for anatomic hemi shoulder prosthesis.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study conducted for the Arthrex Fracture Adapter Hemi Shoulder Prosthesis (K181555), based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Fatigue Resilience	The device demonstrated fatigue strength meeting the same acceptance criteria as the predicate device for the desired indications.
Pyrogenicity (Bacterial Endotoxin)	The device meets pyrogen limit specifications.
Substantial Equivalence	The device is substantially equivalent to the predicate device in basic design features and intended uses. Minor differences do not raise questions concerning safety or effectiveness, based on indications for use, technological characteristics, and submitted data. This is the overarching goal of a 510(k).

Study Details

The provided document describes two types of performance studies: dynamic fatigue testing and bacterial endotoxin testing.

1. Dynamic Fatigue Testing

Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "the proposed construct" and "the proposed devices" but does not specify the number of units tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a mechanical engineering test, not an evaluation requiring expert opinion on diagnostic accuracy.
Adjudication method for the test set: Not applicable. This was a mechanical engineering test.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a mechanical device, not an AI or imaging diagnostic device that would require an MRMC study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
The type of ground truth used: The "ground truth" for this test would be the established mechanical limits and performance characteristics of the predicate device, against which the new device's fatigue strength was compared.
The sample size for the training set: Not applicable. There is no "training set" for this type of mechanical testing.
How the ground truth for the training set was established: Not applicable.

2. Bacterial Endotoxin Testing

Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions that the test was "conducted" but doesn't specify the number of devices or samples tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a laboratory test following recognized standards (EP 2.6.14/USP <85>).
Adjudication method for the test set: Not applicable. This is a standard laboratory test.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: The "ground truth" is defined by the pyrogen limit specifications outlined in EP 2.6.14/USP <85>.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary regarding AI/ML specifics:

It's important to note that the provided document is a 510(k) clearance letter for a mechanical orthopedic implant (shoulder prosthesis components). The questions about multi-reader multi-case studies, standalone algorithm performance, training sets, data provenance, and expert ground truth establishment are typically relevant for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices or diagnostic imaging devices. This document does not describe an AI/ML device, hence most of those specific questions are not applicable to the context of this submission. The "study" here refers to mechanical and biocompatibility testing to ensure the safety and effectiveness of the physical implant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2018

Arthrex Inc. David Rogers Regional Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K181555

Trade/Device Name: Arthrex Fracture Adapter Hemi Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: November 19, 2018 Received: November 20, 2018

Dear David 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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2018.12.21 16:10:24 -05'00' For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181555

Device Name

Arthrex Fracture Adapter Hemi Shoulder Prosthesis

Indications for Use (Describe)

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

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

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510(k) Summary or 510(k) Statement

Date Prepared	December 20, 2018
Submitter	Arthrex Inc.
	1370 Creekside Boulevard
	Naples, FL 34108-1945
Contact Person	David L Rogers
	Regional Manager, Regulatory Affairs
	1-239-643-5553, ext. 71924
	david.rogers@arthrex.com
Name of Device	Arthrex Fracture Adapter Hemi Shoulder Prosthesis
Common Name	Shoulder Prosthesis
Product Code	KWS, HSD
Classification Name	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cementedprosthesis
	21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis
Regulatory Class	II
Predicate Device	K020345: Arthrex Univers Fracture Prosthesis
	K071032: Arthrex Univers II Shoulder Prosthesis
	K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System
Purpose ofSubmission	This Traditional 510(k) premarket notification is submitted to obtain clearance fora product line of fracture adapters to be used with FDA cleared Arthrex humeralstems and heads for anatomic hemi shoulder prosthesis.
Device Description	The fracture adapters are manufactured from Titanium with a hydroxyapatite(HA) coating and are offered in 10 sizes. The Fracture Adapters mate with atrunnion and FDA cleared Arthrex Humeral Stems and Heads for anatomic hemishoulder prosthesis.
Indications for Use	The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for severepain or significant disability resulting from degenerative, rheumatoid, ortraumatic disease or injury of the glenohumeral joint. This includes traumatic orpathological conditions of the shoulder resulting in fracture of the glenohumeraljoint, including impression fractures, comminuted fracture, humeral headfracture, displaced 3-or-4-fragment proximal head fractures, avascular necrosis ofthe humeral head, and fractures of the anatomical neck.The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. Thedevice may be used for hemi or total shoulder repair, utilizing the appropriateArthrex Univers Glenoid component, which is to be cemented in place.
Performance Data	Dynamic fatigue testing was performed to evaluate the fatigue resilience of theproposed construct. The testing demonstrates that the fatigue strength of theproposed devices meets the same acceptance criteria as the predicate device forthe desired indications.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
Conclusion	The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is substantiallyequivalent to the predicate device in which the basic design features and
intended uses are the same. Any differences between the proposed device andthe predicate device are considered minor and do not raise questions concerningsafety or effectiveness.
Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

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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.”